Associate Director, Early Development Quality Lead, R&D QA
Alnylam Pharmaceuticals
August 09, 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 for IND submissions.
- Establish and maintain quality oversight of external laboratories (Test Facilities, Test Sites, and Clinical Laboratories) via a governance framework and ongoing performance monitoring.
- Partner with nonclinical and clinical teams (with GCP Program Leads) to integrate quality into the selection, contracting, and management of external labs.
- Ensure biomarker development/analytical work complies with internal quality system requirements and external regulatory standards (GCP, GLP, ICH, OECD).
- Refine and implement a risk-based vendor oversight and audit program for nonclinical work; lead risk assessment and audit strategy and ensure audits align with the GCP/GLP yearly audit program.
- Support management of lab-focused quality issues from outsourced activities (quality events, significant issues, CAPA oversight).
- Serve as the 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 QMS process improvement opportunities for early development and research; partner with Legal/Procurement for appropriate contractual oversight language.
Qualifications
- Preferred: education in life sciences (technology, biological science, pharmacy, or related); Master’s in a science/technology/industry discipline preferred.
- Minimum 8 years relevant experience, including bioanalytical and toxicology subject matter, related to GLPs, GCPs and GCLPs.
- Preferred: experience in assay development and validation; familiarity with biomarker assays (PCR, ELISA, FISH).
- Prior experience with risk-based thinking, quality assurance, auditing, managing quality issues/escalations, and QMS elements.
- Prior expertise in global GLP/GCP/GCLP regulations and guidance (e.g., FDA, PMDA, EU, MHRA).
- Set strategic quality oversight direction for internal and outsourced laboratory activities supporting nonclinical studies (GLP and non-GLP), including toxicology, bioanalytical and biomarker data for IND submissions.
- Establish and maintain quality oversight of external laboratories (Test Facilities, Test Sites, and Clinical Laboratories) via a governance framework and ongoing performance monitoring.
- Partner with nonclinical and clinical teams (with GCP Program Leads) to integrate quality into the selection, contracting, and management of external labs.
- Ensure biomarker development/analytical work complies with internal quality system requirements and external regulatory standards (GCP, GLP, ICH, OECD).
- Refine and implement a risk-based vendor oversight and audit program for nonclinical work; lead risk assessment and audit strategy and ensure audits align with the GCP/GLP yearly audit program.
- Support management of lab-focused quality issues from outsourced activities (quality events, significant issues, CAPA oversight).
- Serve as the 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 QMS process improvement opportunities for early development and research; partner with Legal/Procurement for appropriate contractual oversight language.
Qualifications
- Preferred: education in life sciences (technology, biological science, pharmacy, or related); Master’s in a science/technology/industry discipline preferred.
- Minimum 8 years relevant experience, including bioanalytical and toxicology subject matter, related to GLPs, GCPs and GCLPs.
- Preferred: experience in assay development and validation; familiarity with biomarker assays (PCR, ELISA, FISH).
- Prior experience with risk-based thinking, quality assurance, auditing, managing quality issues/escalations, and QMS elements.
- Prior expertise in global GLP/GCP/GCLP regulations and guidance (e.g., FDA, PMDA, EU, MHRA).