Insmed Incorporated · 15 hours ago
Manager, Quality Control
Headquarters, NJ
Full-time
Hybrid
Mid, Senior Level
$124K/yr - $161K/yr
5+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Manager of Quality Control will ensure oversight and execution of all aspects of commercial GMP related analytical testing, and will be responsible for managing contract laboratories and ensuring data integrity throughout the product lifecycle.
BiotechnologyMedicalPharmaceutical
Responsibilities
Lead and assist in identifying changes to the processes and impact on the product quality and established procedures
Review, assemble and trend release, IPC, and stability data, generating reports as necessary
Handles contract laboratory vendors, supervises laboratory performance, assesses capability, and ensures actions are taken to improve if needed
Point person for weekly communications with external labs for status updates and testing activities
Measure performance against established Key Performance Indicators (critical metrics), thereby consistently ensuring timely and accurate testing, reporting, and release
Ensures all Out of Specification / Out of Trend results are thoroughly investigated with root cause identified and appropriate corrective actions implemented
Handle method transfer, method development and validation activities at external lab site
Cross-functional liaison working closely with internal collaborators
Statistical programming and data management support is a plus
Develop statistical analysis plans if needed, including the definition of derived data sets and the design of templates for statistical tables, figures, data listings and/or graphs for clinical summary reports
Provide mentorship, support and training to internal / external staff as the need arises
Qualification
Required
BS or BA degree or equivalent in a science or health care field with a preferred focus on chemistry, biochemistry, microbiology, physics, science program
Minimum of 5+ years in the pharmaceutical industry with a GMP testing focus, ideally covering the analytical method and testing lifecycle from development through commercial drug product testing
Knowledge of QC processes and procedures and GMP regulations and mentorship with shown efficiency in maintaining QC processes for compliance with regulations
Expertise in method verification and validation procedures
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to establish and maintain collaborative working relationships with internal and external partners
Ability to take initiative and work independently while optimally handling timelines
Preferred
Knowledge of Statistical programming
Experience of API manufacturing and process chemistry
Excellent presentation skills both verbal and written
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-13
2026-01-11
Company data provided by crunchbase