Senior Analyst, Quality Assurance

Insmed Incorporated

8d

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: Reporting to the Director, Quality - QC Oversight, the Senior Analyst is responsible for providing Quality Assurance oversight of internal and external Quality Control activities supporting small molecule and biologics drug product programs. This role ensures analytical testing, stability programs, and laboratory operations are conducted in compliance with cGMP regulations, global health authority guidelines, regulatory filings, and company procedures. The Senior Analyst serves as the primary QA point of contact for assigned products or laboratory functions, independently managing routine quality oversight and laboratory record approvals while escalating complex, high-risk, or strategic matters to QA leadership as appropriate. This position requires a strong quality mindset, technical understanding of analytical testing, and the ability to apply risk-based decision-making to maintain compliant, inspection-ready operations aligned with product lifecycle requirements.

Requirements

• You have a minimum of a Bachelor’s degree in Chemistry, Engineering, Life Sciences, or a related discipline required.
• Minimum of 5+ years of Quality Assurance experience within the pharmaceutical or biotechnology industry, preferably supporting Quality Control operations.
• Experience supporting small molecules and/or biologics experience required
• Strong knowledge of cGMP regulations and global laboratory compliance standards (FDA, EMA, ICH).
• Experience with deviations, investigations, CAPAs, change controls, and method validation oversight.
• Working knowledge of data integrity principles and regulatory expectations, including electronic records and laboratory systems compliance.
• Familiarity with risk management tools (e.g., FMEA) and risk-based decision-making.
• Solid understanding of QC laboratory operations and analytical testing.
• Familiarity with analytical techniques such as HPLC/UPLC, LC-MS, dissolution, pH, IR, and related methodologies.
• Experience with quality and laboratory systems (e.g., Veeva, LIMS, Empower, BMRAM or equivalent).
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Ability to work independently while managing multiple priorities in a dynamic environment.
• Excellent written and verbal communication skills.
• Highly organized with strong attention to detail, accuracy, and clarity.

Responsibilities

• Provide QA oversight of internal and external QC laboratory operations to ensure compliance with cGMP regulations and global health authority requirements.
• Serve as the QA point of contact for assigned products, stability programs, and/or laboratory functions.
• Review and approve release and stability testing documentation, raw material qualifications, method validation protocols and reports, and equipment qualification documentation.
• Review and approve SOPs, deviations, investigations, CAPAs, change controls, and supplier notifications.
• Provide QA oversight of OOS, OOT, and atypical laboratory investigations to ensure scientifically sound root cause analysis and compliant documentation.
• Assess quality impact of laboratory events and escalate high-risk, cross-functional, or potentially regulatory-impacting issues to QA management as appropriate.
• Review and approve equipment calibration and maintenance documentation.
• Ensure compliance with data integrity requirements, including 21 CFR Part 11.
• Ensure analytical methods and documentation remain aligned with regulatory filings and current product registrations.
• Track record status and analyze laboratory metrics and analytical trends to support compliance and continuous improvement.
• Participate in cross-functional discussions to provide quality input and risk-based recommendations.
• Support internal and external audits, regulatory inspections, and supplier-related quality activities as needed.
• Partner with QC to drive continuous improvement initiatives and maintain audit readiness.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level