International Manager Salary in Bridgewater, NJ

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview Reporting to the Executive Director Quality GMP Compliance, the Director, Quality Operations will play a key role in managing QA and QC oversight activities for Insmed. He/she will be responsible for Quality related activities for commercial products including transition from development (Phase III) into commercial. Role is also responsible for critical supplier relationships and active Quality engagement with these suppliers. This is a supervisory position with 3-6 individual direct reports. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Responsible for final product Quality release/rejection and related processes. Partner with other Regional Quality Directors to ensure transparent communication and assess any product related issues. Impact assessment includes proper evaluation for Health Authority reporting (FAR, Quality Defect, Recalls, etc) and escalation within QA. Responsible for supplier day to day relationships of critical suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality, consistent supply. Review and monitor all lab processes to ensure they follow relevant regulatory GMPs and global company policies & procedures Lead overall management of Quality Assurance programs to support the QC lab and to ensure they are meeting expectations, which include oversight of raw material qualification, lab investigations, stability program, etc Provide oversight of QC equipment program, which includes qualification, calibration, PM, etc Review and approve deviations, CAPAs, SOPs and Change Control related to QC Lab and operations Partners within QA team to execute supplier risk mitigation strategies, supplier assessments, and Quality Agreements. This may include active participation on Joint Steering Committees, frequent communication with QA Leadership, and direct support of Insmed Person In Plant (PIP). Responsible for QA representation in Design Control Process for medical device products and combination products. Lead the quality assessment for product lifecycle changes, efficiency projects, and continuous improvement projects. Manage the performance and development of 3-6 direct reports. Support supplier and internal audits as necessary. Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc. Act as company's representative during regulatory agencies and customer inspections. Supports the investigation of product and related CAPAs. Partner with colleagues in other departments to increase the overall effectiveness of the Quality Assurance department. Support Statistical Trending of Manufacturing and Analytical Data. Additional duties as assigned Qualifications BS degree in Chemistry, Engineering, Life Science or related discipline and a minimum of 15 years of relevant Quality Assurance experience; advanced degree and a minimum of 10 years relevant experience required Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance. Commercial drug manufacturing site QA head experience preferred Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness. Ability to solve complex problems and take proactive action Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual. Maintain professionalism, self-motivation, and enthusiasm. Must be thoroughly knowledgeable on cGMP's, and familiar with other Regulatory Requirements applicable to a drug, medical device and combination product manufacturing and testing. Must perform statistical analysis and capable of analyzing data to solve problems Experience developing and overseeing laboratory SOPs and revisions according to FDA/ICH guidelines Solid knowledge of all QC laboratory equipment and manufacturing equipment Direct experience with investigations and root cause analysis in pharmaceutical or medical device products. Experience with internal and external audits. Experience reviewing manufacturing and QC validation documents. Preferred ASQ CQE and CQA Certifications. Medical device and Risk Management experience preferred, i.e. ISO 13485 and ISO 14971. Demonstrate ability to manage projects and variable workloads. Excellent communication and coaching skills (verbal and written). Highly organized with a strong attention to detail, clarity, accuracy, and conciseness. Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). Travel Requirements Up to 30% travel, both domestic and/or international. Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $200,000.00 to $280,000.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview Reporting to the Executive Director of Development Quality Assurance, the Senior Director of Pharmacovigilance QA serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance and Medical/Clinical Departments. The incumbent will provide support and promote collaboration internally and externally to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines in partnership with Drug Safety and Pharmacovigilance (DSPV) representative. Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Facilitate and maintain a risk-based and scientific-based quality system to support Good Pharmacovigilance Practice (GVP). Establish and maintain Pharmacovigilance inspection readiness in collaboration with DSPV subject matter expert (SME) and act as company's representative during regulatory agency inspections and vendor audits. Ensure that a risk-based audit plan is developed, designed and implemented, and that the activities are conducted, reports written according to SOPs and that QEs/CAPAs are written, reviewed and followed up. Structure and conduct internal Pharmacovigilance systems audits Supports the evaluation and acceptability of Pharmacovigilance vendors for potential use and provides direction, guidance and strategicconsultation for the company. Conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports along with reviewing and monitoring QE's/CAPAs. CQA representative for review of PV SOPs/WIs, PSMF, SDEA's, JOGs and other PV related documents. Supports strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks. Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources. Qualifications: Minimum BS degree in Chemistry or related life sciences discipline required with minimum 10-15 years of experience, 7 years of which are in Pharmacovigilance. Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered. Requires solid experience with pharmacovigilance in Phases I-IV (particularly Phase III) and post-marketing. Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required. Strong knowledge and understanding of drug and device FDA, EU and ICH regulations, pharmacovigilance regulations/processes and HA inspection procedures is required. Experience developing SOPs, reviewing internal pharmacovigilance, clinical, regulatory, and medical processes to ensure they are accurately represented in current SOPs is essential. CQA representative on weekly/monthly pharmacovigilance meetings. Ability to organize and conduct internal audits is necessary. Ability to conduct external audits on PV vendors, CROs, Specialty Pharmacies and monitoring organizations with responsibility for writing audit reports as well as reviewing and tracking CAPAs. Broad knowledge of risk-based quality systems approaches consistent with post-marketing Good Pharmacovigilance Practices and ICH E-6 for Good Clinical Practice. Must successfully exhibit Insmed's five (5) core values of: Passion, Respect, Integrity, Accountability and Collaboration. #LI-KM #LI-Hybrid Qualifications M #LI-Hybrid Travel Requirements Ability to travel both domestically and internationally, approximately 25%-30%. Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $200,000.00 to $280,000.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.

RESPONSIBILITIESSet standards across the team and lead a customer centric approachLead the team as one integrated teamDevelop the team: from administrative to proactive, customer focusOversee the achievement and maintenance of agreed customer service levels and standard KPI'sBe in close contact with the sales and supply chainCollaborate with commercial managers to prioritize and ensure USA business continuity in a smooth wayBring the wide company perspective into the teamCreate and implement standardize processes and procedures to the team related to the daily activities, within the systems we use (ERP, CRM, BY): samples handling, questionnaires, complaints, CN, RFC, order to invoice handlingSupport commercial manager with sales, RFC and WP analysis and gap follow upFollow up service quality levelFollow up on new projects/customers added into the team, keep the work balance across the teamFollow up on some key strategic customers and all contract/BPOExecuting customer communication activities (QA related notifications or marketing)Guiding the team in the event of a crisis to ensure support to our customers.QUALIFICATIONSBusiness / commercial education is a plusMinimum of 5 years of relevant B2B experienceMinimum of 3 years of team leading experienceIdeally experience with a value-added solution providerFluent in English and excellent written and verbal communication skills.Analytical mindsetDesire to work in an international, multicultural environmentDiscipline to initiate first contact and to make the first stepService orientationExperience with Microsoft, CRM/ERP softwareSound conversation techniques

Company Description Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Recognitions Named Science's Top Employer in 2021, 2022, and 2023 Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we were named the No. 1 company to work for in the biopharma industry in Science's Top Employers Survey for two years in a row. A Certified Great Place to Work We believe our company is truly special, and our employees agree. In July 2023, we became Great Place to Work-certified in the U.S. for the third year in a row. We are also honored to have been listed on the Best Workplaces in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists. Overview The Manager of Supply Chain and Logistics plays a crucial role in supporting both the commercial and clinical supply chains at Insmed. The primary focus is on managing import/export requirements and collaborating with third-party logistics companies. This position involves serving as the main point of contact for partners, ensuring on time, compliant, day-to-day shipment management, monitoring vendor performance through KPIs, and tracking budgets. The role also requires contributing to build and maintain Insmed's master data management practices, as well as implementing and monitoring DSCSA compliance initiatives. This is a non-supervisory position This role oversees vendors and/or contractors Responsibilities Additional representative responsibilities will include, but not necessarily be limited to, the following: Strategic Planning Collaborate with senior leadership and cross-functional teams to develop and implement strategic plans for the supply chain and logistics operations. Identify and assess potential risks in the supply chain and propose mitigation strategies. Vendor Management Establish and maintain strong relationships with third-party logistics companies and other relevant vendors. Oversee day-to-day interactions with vendors, ensuring adherence to contractual agreements and performance expectations. Monitor and analyze vendor management key performance indicators (KPIs). Shipment Management Oversee the day-to-day management of shipments, ensuring timely and accurate deliveries. Implement tracking systems to monitor the progress of shipments and address any issues that may arise. Implement quality control measures to ensure the integrity and safety of shipped products. Investigate and address any deviations from quality standards in collaboration with relevant teams. Budget Tracking Develop and manage budgets for supply chain and logistics operations. Monitor expenditures, identify cost-saving opportunities, and ensure financial objectives are met. Import/Export Compliance Ensure compliance with all import/export regulations and requirements. Stay informed about changes in international trade regulations and implement necessary adjustments to the supply chain processes. DSCSA Compliance Demonstrate expertise in the Drug Supply Chain Security Act (DSCSA) requirements. Implement and oversee compliance measures to ensure the traceability and security of pharmaceutical products throughout the supply chain. Master Data Management Utilize experience with master data management to ensure accurate and consistent data across the supply chain systems. Implement and maintain data governance practices to enhance data quality and reliability. Qualifications Qualifications Bachelor's degree in Supply Chain Management, Logistics, Business, or a related field. Master's degree is a plus. Proven experience (5 years) in supply chain and logistics management, preferably in the biotech or pharmaceutical industry. Skills Strong understanding of import/export regulations and compliance. Experience with master data management practices. Familiarity with DSCSA regulations and compliance. Demonstrated experience in managing third-party logistics companies and vendor relationships. Excellent project management and organizational skills. Strong analytical and problem-solving abilities. Effective communication and interpersonal skills for cross-functional collaboration. Proficiency in relevant software and technology, including supply chain management systems. #L #LI-KM #LI-Hybrid Travel Requirements Able to travel up to 10% (Domestic and/or International) Salary Range Insmed takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary level for potential new employees. The base salary range for this job is from $108,000.00 to $150,667.00 per year Compensation & Benefits We're committed to investing in every team member's total well-being, now and in the future. We offer a competitive total-rewards package to all employees around the world, including: Flexible approach to where and how we work Competitive compensation package including bonus. Stock options and RSU awards Employee stock purchase plan 401(k) plan with company match Professional Judgment Vacation Policy 11 paid holidays per year and Winter Break (typically between Christmas and New Year's Day). ADDITIONAL U.S. BENEFITS: Medical, dental, and vision plans Company-provided short- and long-term disability plans Company-provided life insurance Unique offerings of pet, legal, and supplemental life insurance Flexible spending accounts for medical and dependent care Accident and Hospital Indemnity plans Supplemental AD&D Employee Assistance Program (EAP) Mental Health on-line digital resource On-site, no-cost fitness center at our U.S. headquarters Paid time off to volunteer Additional Information Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.Applications are accepted until the position is filled.#LI-JK1

Location: Bridgewater, NJDescription: MUST HAVE SKILLS (Most Important):Minimum 4 years project planning and project management experience Strong Excel, SQL, data visualization, and presentation skills Client focused approach Superior oral and written communication skills Programming ability in one of the following languages JavaScript or Python, and Google Apps Script. DESIRED SKILLS: Strong project management skills Strong partnering skills Strong analytical skills Strong attention to detail Solid technical, business and financial acumen Ability to collaborate effectively with business unit personnel in a range of activities from clearance drafting and approval to periodic compliance reviews Ability to keep accurate records and produce management reports JOB DUTIES: The successful candidate will need a strong technical and project management background. They will be responsible for facilitating reviews of global service requests requiring global clearance, on behalf of all Organization business units. He/she will review, analyze, manage & recommend course of action on all global clearance requests from the inception of a project through completion of the clearance, working directly with the project team to determine the clearance type required and prepare all clearance documentation. The candidate will have programming ability in one of the following languages JavaScript or Python, and Google Apps Script. The candidate will have experience in automating collaboration and workflow processes with Gsuite. These skills will allow the candidate to provide operational support for the Business Clearance internal online presence such as managing Google documentation, process automation and KPI and metrics management. Job Duty / Responsibility (60% of Time) 1. Lead Organization business units in the global clearance development and approval process for moving work offshore, drive participants to meet SLAs, and own the process of keeping Records and Reporting on Results to Management. The end to end Clearance Process is a multi-layered, project specific assessment of information and operational risk, and the actions required to obtain authorization for the proposed offshore work Partner with domestic and international business units in drafting new and revised clearances. (The Clearance Analyst provides expertise with complex clearance rules and requirements, and the business unit personnel contribute knowledge of what the business wishes to get cleared). Partner with domestic and international business units in presenting clearance requests to approvers, following up on any requests for additional information or modifications, and obtaining all required approvals. Partner with domestic and international attorneys to review and evaluate clearance requests and ensure that they comply with country regulations and legal requirements. Interpret complex Clearance policies and rules and apply to individual clearances in creative and practical ways to facilitate approval and minimize exception requests. Ensure that assigned business personnel understand the role of the business unit in creating clearance requests and shepherding these through the approval process. Keep an accurate record of progress on assigned clearances, monitor progress against clearance timeline, and keep management apprised of any jeopardies that may arise, along with recommendations on addressing these jeopardies. Take ownership for driving all participants in the process to meet clearance timelines. Provide periodic management reporting on clearance timeliness and throughput.2. Working with the Clearance Manager, drive the process of continually improving the clearance development, approval, and record-keeping methodologies while also evolving these to support new business needs. 3. Provide Compliance guidance to the business units by working directly with clearance owners to ensure that they understand the rules for compliance for each clearance.Instruct clearance owners on the process for periodic self-assessment and verification of ongoing compliance with clearance parameters and conditions.Recommend improvements to the compliance aspect of the clearance process. Use lessons learned from the compliance aspect of the clearance process to drive down the incidence of non-compliance over time. Job Duty / Responsibility (40% of Time) 1. Operational- Participate in the build out of the internal online presence for the Global Clearance team. Use skills deploying Google sheets to streamline data collection, enhance collaboration, task assignment, and key documentation efforts in support of the Business Global Clearance process 2. Support Analytics strategy for Business Clearance team. Further Business Clearance analytics efforts to achieve a data driven approach for risk analysis and project management. EDUCATION/CERTIFICATIONS:Bachelors degree required ? Masters degree desirable and/or a combination of equivalent work experience Contact: [email protected] job and many more are available through The Judge Group. Find us on the web at www.judge.com