Evaluation 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.

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, Learning & Development role will design and develop engaging, innovative, and impactful learning experiences to enable the development of our organization now and in the future. This role is responsible for creation of learning solutions that span the 70:20:10 and leverage multiple modalities to bring learning to life in the flow of work. The Manager, Learning & Development will collaborate with stakeholders across the organization, leveraging data, insights, and feedback to identify and address leadership and power skill development needs. Collaboration and creativity are critical in this role to support a culture of learning and develop user-centric learning experiences that enable our employees and leaders to grow and thrive in their careers at Insmed. Responsibilities Responsibilities Apply adult learning theory and design thinking to design, develop, pilot and deliver engaging and effective learning experiences utilizing a variety of modalities, methods, and toolsSource, develop and customize content from a variety of internal and external sources (including LinkedIn Learning) to address organizational learning needsAssess organizational learning needs to ensure learning solutions developed are aligned with organization goals and strategyChampion a culture of learning at Insmed, including support for the use of innovative learning experiences, such as social learningLeverage strong collaborative partnerships with internal subject matter experts to incorporate insights, feedback and Insmed culture into learning solutions to effectively close capability gapsEffectively project manage learning projects to deliver effective content or solutions on time and on budgetCoordinate with external vendors to develop learning solutions in line with Insmed culture and organization needsUtilize creativity and design skills to create course assets and communications that are engaging and compellingContinuously innovate and improve learning design and approach by staying ahead of learning & development industry trends, tools, and technology, including AIAnalyze reporting and evaluation of learning solutions to ensure effectiveness, positive impact, and strong ROIAct as Learning Administrator for Workday Learning (LMS), ensuring a positive learning experienceQualificationsBachelor's degree in Human Resources, Organization Development, Education, or other related field required5+ years of related Learning & Development experience required, with a focus on LX/instructional design; prior experience in Pharma and/or Biotech a plusDemonstrated experience designing and developing learning programs and related assets in multiple synchronous and asynchronous modalities, including instructor-led learning, eLearning, and social learningExperience designing learning solutions for a cross-functional, multi-level Global audienceHighly proficient in Articulate 360, Vyond, Adobe Creative Suite, Microsoft Office 365 suite, and other learning/content development toolsExcellent verbal and written communication skillsStrong project management skills, with a proven ability to manage multiple projects simultaneouslyKnowledge of adult learning, instruction design methodology and tools, design thinking and current L&D trendsExceptional attention to detail and follow through, with ability to be flexible and adapt to in a fast-paced, evolving environmentAbility to cultivate relationships, consult and collaborate across all levels and functions within a global organizationAbility to maintain a high level of confidentialityExperience with Learning Management Systems or Learning Experience Systems; prior experience with Workday Learning a plus#LI-JT1#LI-Hybrid Travel Requirements Less than 10% travel 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 withcompanymatch 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.

Location: Bridgewater, NJSalary: NegotiableDescription: Our client is currently seeking a User Researcher - III [Additional Description] JOB DESCRIPTION JOB TITLE: UX Researcher, B2B OVERVIEW: Client is seeking a mid-to-senior level User Experience (UX) Researcher to join the Customer Marketplace Insights (CMI) team. You will help drive transformation and innovation by contributing insights and research outcomes that translate directly into business and product impacts. As a UX Researcher, you will be a core member of the team focused on business customers. Tightly partnered with Experience Designers and Managers, you will collaborate with the larger UX Research team as well as our wider CMI organization to develop and execute UX Research projects/programs aimed at understanding business customer needs, expectations, and experiences. Activities will range from early/generative user research, through rapid/iterative formative testing, and later evaluation. You have a critical approach to research. You're always looking for sources of bias. As appropriate, you challenge the use of research techniques, and suggest techniques better suited to a scenario. You understand when less-direct data gathering methods may be appropriate, e.g. observation vs interviewing when studying a business process. You have a healthy sense of "some things are difficult to know through research" and are quick to think about (and communicate to stakeholders) limitations to various research approaches. In this role you will: - Execute research activities (e.g. user interviews/testing/evaluation, field studies, journey mapping.) to uncover experience and product development insights - Produce research documents ? screeners, question guides, reports, et cetera - Moderate/host workshops such as ideation sessions - Build impactful and influential insights and stories spotlighting the most client-relevant user orientations and behaviors - Perform desk research (e.g. lit reviews) to inform the front end of new projects. - Manage the research participant experience, to ensure their comfort during research sessions, and protect their personal/private data. - Collaborate with and manage stakeholders across various functions/disciplines. EXPERIENCE REQUIRED: - Bachelor's degree in a research-related discipline - Five or more years of related non-academic work experience in a dedicated research role (we are not looking for someone who dabbles in research or has been research-adjacent in another function) - Experience defining and planning the approach and methodologies in context of project scope and timeline. - Experience with user research methods (usability testing, user interviews, diary studies, et cetera). - Experience crafting discussion guides and appropriate tools and exercises to reveal customer/user needs and desires - Experience moderating and planning field studies, user interviews, and usability studies in in-person and remote testing environments. - Experience with qualitative generative research, evaluative methodologies, and usability from concept formation through launch. - You have at least a non-specialist understanding of quantitative research ? you know the basics, and have a good sense of when to ask a specialist for help or look something up. - Experience with secondary data, trends, and learnings. - Experience demonstrating UX Research impact, including driving business and product decisions through UX Research. - You have worked in close partnership with designers and business units. - You are adept at managing stakeholders and understanding the orientations and needs of different business functions within a large organization. - Experience with project management in cross-functional teams - Experience working in an Agile environment. - Detail-oriented approach and the ability to work fairly independently on a variety of tasks. - Strong oral and written communication skills. EVEN BETTER IF YOU HAVE: - Masters or Ph.D. in Anthropology, Human Factors, Psychology, HCI/Computer Science, or a related field. - Experience providing insights to inform digital engagement (such as websites, apps, and APIs) - Experience with learning programs. - Experience with B2B workstreams - Partner, vendor, and resource management experience - Some understanding of semiotics Contact: [email protected] job and many more are available through The Judge Group. Find us on the web at www.judge.com