Associate Director, Early Development Quality Lead, R&D QA
Alnylam Pharmaceuticals
June 27, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Key Responsibilities:
- Set strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical studies (GLP and non-GLP), including toxicology, bioanalytical and biomarker data supporting IND submissions.
- Establish and maintain quality oversight of external laboratories (Test Facilities/Sites and Clinical Laboratories) via governance framework and ongoing performance monitoring.
- Partner with nonclinical and clinical teams (with GCP Program Leads) to integrate quality into selection, contracting, and management of external labs.
- Ensure internally developed and outsourced biomarker development/analytical work complies with internal quality system requirements and external standards (GCP, GLP, ICH, OECD).
- Refine and implement a global, risk-based vendor oversight and audit program; lead risk assessment/audit strategy and ensure audits align with the GCP/GLP yearly audit program.
- Manage nonclinical/clinical lab quality issues from outsourced activities, including quality events, significant quality issues, and CAPA oversight.
- Serve as quality escalation point for CRO/vendor quality issues and lead quality governance to mitigate emerging compliance risks.
- Provide quality strategic direction for evaluation of CRO/vendor processes and process improvement opportunities.
- Drive process improvement opportunities within the QMS for early development and research.
- Partner with Legal/Procurement on appropriate contractual oversight language and ensure compliance.
Qualifications:
- Education in life sciences or equivalent; Master’s degree preferred.
- Minimum 8 years relevant experience including bioanalytical and toxicology subject matter related to GLPs, GCPs, and GCLPs.
- Assay development/validation experience; familiarity with biomarker-based assays (PCR, ELISA, FISH) preferred.
- Experience with risk-based thinking, quality assurance, auditing, and managing quality issues/escalations or other QMS elements.
- Expertise in global GLP/GCP/GCLP regulations and guidance (e.g., FDA, PMDA, EU, MHRA).
Benefits:
- Annual short-term incentive award and annual long-term incentive award (bonus/equity).
- Medical, dental, vision, life/disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) with match; paid time off, wellness days, holidays, and recharge breaks.
U.S. Pay Range: $164,500.00 - $222,500.00
Location: US (hybrid/onsite/remote).
- Set strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical studies (GLP and non-GLP), including toxicology, bioanalytical and biomarker data supporting IND submissions.
- Establish and maintain quality oversight of external laboratories (Test Facilities/Sites and Clinical Laboratories) via governance framework and ongoing performance monitoring.
- Partner with nonclinical and clinical teams (with GCP Program Leads) to integrate quality into selection, contracting, and management of external labs.
- Ensure internally developed and outsourced biomarker development/analytical work complies with internal quality system requirements and external standards (GCP, GLP, ICH, OECD).
- Refine and implement a global, risk-based vendor oversight and audit program; lead risk assessment/audit strategy and ensure audits align with the GCP/GLP yearly audit program.
- Manage nonclinical/clinical lab quality issues from outsourced activities, including quality events, significant quality issues, and CAPA oversight.
- Serve as quality escalation point for CRO/vendor quality issues and lead quality governance to mitigate emerging compliance risks.
- Provide quality strategic direction for evaluation of CRO/vendor processes and process improvement opportunities.
- Drive process improvement opportunities within the QMS for early development and research.
- Partner with Legal/Procurement on appropriate contractual oversight language and ensure compliance.
Qualifications:
- Education in life sciences or equivalent; Master’s degree preferred.
- Minimum 8 years relevant experience including bioanalytical and toxicology subject matter related to GLPs, GCPs, and GCLPs.
- Assay development/validation experience; familiarity with biomarker-based assays (PCR, ELISA, FISH) preferred.
- Experience with risk-based thinking, quality assurance, auditing, and managing quality issues/escalations or other QMS elements.
- Expertise in global GLP/GCP/GCLP regulations and guidance (e.g., FDA, PMDA, EU, MHRA).
Benefits:
- Annual short-term incentive award and annual long-term incentive award (bonus/equity).
- Medical, dental, vision, life/disability insurance; lifestyle reimbursement; flexible spending/HSAs; 401(k) with match; paid time off, wellness days, holidays, and recharge breaks.
U.S. Pay Range: $164,500.00 - $222,500.00
Location: US (hybrid/onsite/remote).