Manager, Quality Control

About the role

We're looking for a Manager, Quality Control (QC) on the Quality Control team to help us expand what's possible for patients with serious diseases. Reporting to the Associate Director, Quality Control, you'll independently lead and oversee all QC activities conducted at external contract laboratories for inhalation and small molecule drug substance, drug products, including raw materials, in-process, release, and stability testing. You will manage analytical projects, deviations, and investigations while ensuring all testing activities are compliant with cGMP, regulatory standards, and Insmed’s quality expectations.

Responsibilities

• Independently manage and provide technical oversight of QC testing conducted at contract laboratories for drug substances and drug products, with emphasis on inhalation dosage forms
• Lead analytical project activities from initiation through completion, ensuring testing aligns with project timelines, quality expectations, and regulatory requirements
• Review analytical data packages, protocols, test results, and reports for completeness, accuracy, and compliance with internal and external standards
• Independently manage deviations, out-of-specification (OOS), out-of-trend (OOT) investigations, and change controls, including performing root cause analysis and implementing effective CAPAs
• Support and drive analytical method implementation and troubleshooting related to APSD, MMAD, delivered dose, and particle size distribution testing
• Ensure timely review and approval of Certificates of Analysis (CoAs), method validation/transfer protocols, and analytical methods from external labs to enable batch disposition
• Lead the development and review of product specifications and justification documents for clinical and commercial programs
• Author, review, and contribute to QC sections of regulatory submissions (INDs, NDAs) and prepare responses to regulatory agency inquiries
• Monitor and evaluate contract laboratory performance metrics, providing technical guidance and escalating issues as needed
• Drive continuous improvement initiatives within QC and external lab oversight processes

Requirements

• You have a Bachelor's degree in Chemistry, Biochemistry, or a related scientific field along with 4 years of Quality Control experience within the biotech/pharmaceutical industry.
• You are or you also have:
• Experience in analytical testing of small molecule or inhalation drug products
• Nice to have:
• Advanced degree (MS)
• Familiarity with combination products
• Strong understanding of cGMP regulations, ICH guidelines, and global compendial standards (USP/EP/JP)
• Experience with oversight of contract testing labs
• Experience reviewing analytical data and technical documents such as CoAs, protocols, and regulatory submissions
• Analytical and problem-solving skills, including participation in investigations and CAPA implementation
• Effective communication and collaboration skills with ability to interface with internal teams and external partners
• Time management and prioritization abilities, with attention to quality and compliance

Qualifications

• You have a Bachelor's degree in Chemistry, Biochemistry, or a related scientific field along with 4 years of Quality Control experience within the biotech/pharmaceutical industry.
• You are or you also have:
• Experience in analytical testing of small molecule or inhalation drug products
• Nice to have:
• Advanced degree (MS)
• Familiarity with combination products
• Strong understanding of cGMP regulations, ICH guidelines, and global compendial standards (USP/EP/JP)
• Experience with oversight of contract testing labs
• Experience reviewing analytical data and technical documents such as CoAs, protocols, and regulatory submissions
• Analytical and problem-solving skills, including participation in investigations and CAPA implementation
• Effective communication and collaboration skills with ability to interface with internal teams and external partners
• Time management and prioritization abilities, with attention to quality and compliance

Skills

• Strong technical judgment, leadership, and decision-making ability
• Strong understanding of cGMP regulations, ICH guidelines, and global compendial standards (USP/EP/JP)
• Experience with oversight of contract testing labs
• Experience reviewing analytical data and technical documents such as CoAs, protocols, and regulatory submissions
• Analytical and problem-solving skills, including participation in investigations and CAPA implementation
• Effective communication and collaboration skills with ability to interface with internal teams and external partners
• Time management and prioritization abilities, with attention to quality and compliance

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support
• 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
• Employee 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

Pay

$124,000.00 - $161,000.00 Annual