BioSpace, Inc.
Job Details
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 four 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: The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.
What You'll Do: Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards. Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies. Oversee QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and protocols/reports. Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs. Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance. Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up. Drive phase-appropriate quality system improvements for development-stage programs. Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy. Lead and develop a team of 2-8 Quality professionals supporting development programs; provide coaching, feedback, and career growth opportunities. Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation. Create, maintain, and enhance Standard Operating Procedures governing Development QA activities. Support investigations and root cause analysis of product or process issues related to clinical manufacturing. Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs. Responsible for final product Quality release/rejection and related processes. Support supplier and internal audits as necessary. Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc Additional duties as assigned Who You Are:
BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred. Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage programs; advanced degree may substitute for years of experience. Minimum 7 years of direct GxP experience (GMP, GCP, and/or GLP) in a regulated environment supporting biologics, drug products, or combination products. Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development. Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and vendor management experience. Proven expertise in root cause analysis, investigations, change control, and Quality risk management. Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes. Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment. Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels. Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input. Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills. Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending/statistical analysis preferred. ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred. Travel - 40% domestic and/or international
#LI-JT1 #LI-Hybird
Pay Range: $207,000.00-289,867.00 Annual
Life at Insmed
At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
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 Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company
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 contribution to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four 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, each other, and the future of science, we're in. Are you?
Company info Website https://insmed.com/ Phone (908)977-9900 Location 700 US Highway 202/206 Bridgewater New Jersey 08807 United States
Share this job
Facebook Twitter LinkedIn
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 four 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: The Sr. Director CMC QA will lead QA CMC oversight for drug products, biologics, and combination product programs from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality leadership across internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, evolving pipelines.
What You'll Do: Provide strategic and operational Quality leadership for development programs from toxicology through Phase 3, ensuring compliance with GMPs and internal standards. Serve as the Quality lead for GMP activities supporting clinical trial materials, including DS/DP used in early and late-phase studies. Oversee QA support for development-stage manufacturing, analytical, and, including review and approval of deviations, CAPAs, change controls, and protocols/reports. Collaborate cross-functionally with CMC team, Regulatory, Clinical Operations, and Program Management to drive proactive Quality input into development programs. Provide Quality oversight of contract development and manufacturing organizations (CDMOs), and other GxP vendors used for clinical trial materials and services. Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and vendor qualification activities to ensure phase-appropriate compliance. Actively represent QA in technical development activities, including process development, method validation/transfer, formulation work, and scale-up. Drive phase-appropriate quality system improvements for development-stage programs. Participate in Quality governance forums, providing expert input on GMP requirements and ensuring alignment with global Quality strategy. Lead and develop a team of 2-8 Quality professionals supporting development programs; provide coaching, feedback, and career growth opportunities. Support regulatory submissions (e.g., IND, IMPD, BLA sections) by reviewing or contributing Quality input and documentation. Create, maintain, and enhance Standard Operating Procedures governing Development QA activities. Support investigations and root cause analysis of product or process issues related to clinical manufacturing. Drive Quality input into lifecycle changes, process optimizations, and continuous improvement initiatives across development programs. Responsible for final product Quality release/rejection and related processes. Support supplier and internal audits as necessary. Create and maintain Standard Operating Procedures relating to areas of responsibility including product release, design control, etc Additional duties as assigned Who You Are:
BS degree in Life Sciences, Chemistry, Engineering, or related discipline; advanced degree (MS, PhD, PharmD) strongly preferred. Minimum of 15 years of relevant Quality Assurance experience in the biopharmaceutical industry, including at least 10 years supporting development-stage programs; advanced degree may substitute for years of experience. Minimum 7 years of direct GxP experience (GMP, GCP, and/or GLP) in a regulated environment supporting biologics, drug products, or combination products. Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts 210/211, 600s, 820, ICH, EU Annexes, ISO 13485/14971), and compliance expectations across clinical development. Demonstrated success in QA oversight of CDMOs, CROs, and testing labs, including audit and vendor management experience. Proven expertise in root cause analysis, investigations, change control, and Quality risk management. Direct experience with clinical manufacturing, analytical method development/validation, tech transfer, and design control processes. Strong leadership skills with experience managing and developing high-performing QA teams in a fast-paced, matrixed environment. Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels. Experience supporting regulatory submissions (e.g., IND, IMPD, BLA/MAA) with high-quality documentation and Quality strategy input. Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills. Proficient in Microsoft Office and quality system tools (e.g., Veeva, TrackWise, MasterControl); familiarity with data trending/statistical analysis preferred. ASQ certifications (CQA, CQE) and prior experience in a global development organization are strongly preferred. Travel - 40% domestic and/or international
#LI-JT1 #LI-Hybird
Pay Range: $207,000.00-289,867.00 Annual
Life at Insmed
At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.
Highlights of our U.S. offerings include:
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 Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.
Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. 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.
Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.
Applications are accepted for 5 calendar days from the date posted or until the position is filled.
Company
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 contribution to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for four 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, each other, and the future of science, we're in. Are you?
Company info Website https://insmed.com/ Phone (908)977-9900 Location 700 US Highway 202/206 Bridgewater New Jersey 08807 United States
Share this job
Facebook Twitter LinkedIn