Associate Director, Early Development Quality Lead, R&D QA
Alnylam Pharmaceuticals
September 03, 2026
Remote friendly (United States)
United States
Operations
Key Responsibilities
- Provide strategic quality oversight for internal and outsourced laboratory activities supporting nonclinical studies (GLP/non-GLP), IND-enabling work, and biomarker use in development programs (preclinical/clinical).
- Establish and maintain quality oversight of external laboratories (test facilities/sites/clinical labs) via governance and performance monitoring.
- Partner with nonclinical and clinical teams (with GCP Program Leads) to integrate quality into selection, contracting, and management of external labs.
- Ensure biomarker development/analytical work meets internal quality system requirements and regulatory standards (GCP, GLP, ICH, OECD).
- Implement risk-based vendor oversight and a global audit program; lead risk assessment/audit strategy and execute planned audits aligned with the GCP/GLP yearly audit program.
- Manage outsourced lab quality issues (quality events, significant issues, CAPA) and lead CRO/vendor quality escalations.
- Provide quality strategic direction for evaluation/improvement of CRO/vendor processes and drive QMS process improvements.
- Partner with Legal/Procurement on quality oversight language in contracts.
Qualifications
- Life sciences education (preferred) or equivalent experience; Master’s preferred.
- 8+ years relevant experience including bioanalytical and toxicology, working with GLP/GCP/GCLP.
- Assay development/validation experience; familiarity with PCR, ELISA, FISH (preferred).
- Experience with risk-based quality assurance, auditing, and managing quality issues/escalations/QMS.
- Expertise in global GLP/GCP/GCLP regulations and guidance (e.g., FDA, PMDA, EU, MHRA).
Compensation/Benefits (as stated)
- U.S. pay range: $164,500.00–$222,500.00; eligible for annual short-term incentive and annual long-term incentive.
- Benefits include medical/dental/vision, life/disability, 401(k) with match, PTO/wellness days/holidays, and more (per Total Rewards).
- Provide strategic quality oversight for internal and outsourced laboratory activities supporting nonclinical studies (GLP/non-GLP), IND-enabling work, and biomarker use in development programs (preclinical/clinical).
- Establish and maintain quality oversight of external laboratories (test facilities/sites/clinical labs) via governance and performance monitoring.
- Partner with nonclinical and clinical teams (with GCP Program Leads) to integrate quality into selection, contracting, and management of external labs.
- Ensure biomarker development/analytical work meets internal quality system requirements and regulatory standards (GCP, GLP, ICH, OECD).
- Implement risk-based vendor oversight and a global audit program; lead risk assessment/audit strategy and execute planned audits aligned with the GCP/GLP yearly audit program.
- Manage outsourced lab quality issues (quality events, significant issues, CAPA) and lead CRO/vendor quality escalations.
- Provide quality strategic direction for evaluation/improvement of CRO/vendor processes and drive QMS process improvements.
- Partner with Legal/Procurement on quality oversight language in contracts.
Qualifications
- Life sciences education (preferred) or equivalent experience; Master’s preferred.
- 8+ years relevant experience including bioanalytical and toxicology, working with GLP/GCP/GCLP.
- Assay development/validation experience; familiarity with PCR, ELISA, FISH (preferred).
- Experience with risk-based quality assurance, auditing, and managing quality issues/escalations/QMS.
- Expertise in global GLP/GCP/GCLP regulations and guidance (e.g., FDA, PMDA, EU, MHRA).
Compensation/Benefits (as stated)
- U.S. pay range: $164,500.00–$222,500.00; eligible for annual short-term incentive and annual long-term incentive.
- Benefits include medical/dental/vision, life/disability, 401(k) with match, PTO/wellness days/holidays, and more (per Total Rewards).