Associate Director, CMC Quality Assurance
Insmed Incorporated
June 25, 2026
Remote
United States
Operations
Associate Director, CMC Quality Assurance
About the Role
Reporting to the Senior Director, CMC Quality Assurance, directs quality-related activities and processes for products in clinical phase studies, including supplier relationships/auditing, batch review/release, site transfers, and internal document setup/review, QMS, and weekly team meetings for drug substance, drug product, packaging, and labeling. Facilitates transition from drug development to commercial product.
What You’ll Do
- Establish and maintain a risk-based, scientific-based quality system and decision-making approach.
- Audit vendor, customer, and outside contract organization manufacturing facilities.
- Facilitate and approve Quality Technical Agreements with vendors.
- Ensure phase-appropriate GMP operations comply while maintaining efficient workflow.
- Apply phase-appropriate GMP compliance principles to quality decisions.
- Lead investigations, CAPAs, deviations, and quality events to resolution and closure.
- Transition Phase 3 clinical stage material to commercial success.
- Manage all quality aspects of Phase 1–Phase 3 clinical projects (raw materials through manufacturing, packaging, distribution, and release).
- Provide department leadership: objective setting, performance appraisal, and individual development.
- Release/reject GMP materials; use QA staff to manage timelines and on-time delivery.
- Prepare/review/approve regulatory- and customer-required reports and documentation.
- Support and train staff to develop auditing resources.
- Represent the company during regulatory agency and customer inspections.
- Identify and lead operational excellence initiatives; partner with other departments to improve Quality effectiveness.
Who You Are
- Minimum BS in Chemistry, Life Science, or related discipline.
- MS/PhD/MBA and 7+ years QA experience in regulated industry (pharmaceutical/biologics/device). If no advanced degree, 10+ years equivalent experience.
You Are or You Have
- Ability to manage staff/projects and variable workloads.
- Full understanding of cGMPs and GLPs; working knowledge of GCPs.
- Understanding of device regulations and development processes.
- Familiarity with pharmaceutical manufacturing (small molecule and biologics).
- Phase I–IV experience (especially Phase III); experience with Regulatory approval, NDAs, and MAAs.
- Experience managing FDA inspections, regulators, and customer audits.
- Experience writing manufacturing and lab investigations.
- Knowledge of risk-based quality systems consistent with ICH Q10.
Where You’ll Work / Travel
Fully remote. Occasional travel for team meetings/events; frequent domestic/international travel up to 25%.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
About the Role
Reporting to the Senior Director, CMC Quality Assurance, directs quality-related activities and processes for products in clinical phase studies, including supplier relationships/auditing, batch review/release, site transfers, and internal document setup/review, QMS, and weekly team meetings for drug substance, drug product, packaging, and labeling. Facilitates transition from drug development to commercial product.
What You’ll Do
- Establish and maintain a risk-based, scientific-based quality system and decision-making approach.
- Audit vendor, customer, and outside contract organization manufacturing facilities.
- Facilitate and approve Quality Technical Agreements with vendors.
- Ensure phase-appropriate GMP operations comply while maintaining efficient workflow.
- Apply phase-appropriate GMP compliance principles to quality decisions.
- Lead investigations, CAPAs, deviations, and quality events to resolution and closure.
- Transition Phase 3 clinical stage material to commercial success.
- Manage all quality aspects of Phase 1–Phase 3 clinical projects (raw materials through manufacturing, packaging, distribution, and release).
- Provide department leadership: objective setting, performance appraisal, and individual development.
- Release/reject GMP materials; use QA staff to manage timelines and on-time delivery.
- Prepare/review/approve regulatory- and customer-required reports and documentation.
- Support and train staff to develop auditing resources.
- Represent the company during regulatory agency and customer inspections.
- Identify and lead operational excellence initiatives; partner with other departments to improve Quality effectiveness.
Who You Are
- Minimum BS in Chemistry, Life Science, or related discipline.
- MS/PhD/MBA and 7+ years QA experience in regulated industry (pharmaceutical/biologics/device). If no advanced degree, 10+ years equivalent experience.
You Are or You Have
- Ability to manage staff/projects and variable workloads.
- Full understanding of cGMPs and GLPs; working knowledge of GCPs.
- Understanding of device regulations and development processes.
- Familiarity with pharmaceutical manufacturing (small molecule and biologics).
- Phase I–IV experience (especially Phase III); experience with Regulatory approval, NDAs, and MAAs.
- Experience managing FDA inspections, regulators, and customer audits.
- Experience writing manufacturing and lab investigations.
- Knowledge of risk-based quality systems consistent with ICH Q10.
Where You’ll Work / Travel
Fully remote. Occasional travel for team meetings/events; frequent domestic/international travel up to 25%.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.