Associate Director, Early Development Quality Lead, R&D QA
Alnylam Pharmaceuticals
August 31, 2026
Remote friendly (Cambridge, MA)
United States
Operations
Overview/Role
The Early Development Quality Lead provides strategic quality oversight of internal and outsourced activities supporting nonclinical studies (GLP/non-GLP) and IND-enabling work, including biomarker utilization in development programs.
Key Responsibilities
- Set strategic quality oversight for internal and outsourced lab activities (toxicology, bioanalytical, biomarker data supporting IND).
- Establish/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 QMS and external standards (GCP, GLP, ICH, OECD).
- Lead risk-based vendor oversight and global audit program; execute audits aligned with GCP/GLP yearly audit plan.
- Support management of outsourced lab quality issues (quality events, significant issues, CAPA oversight).
- Serve as quality escalation point for CRO/vendor issues; lead governance to mitigate emerging compliance risks.
- Provide strategic direction for evaluating CRO/vendor processes and process improvements.
- Drive QMS process improvement in early development/research; partner with Legal/Procurement on contractual oversight language.
Qualifications
- Life sciences (or related) education preferred; Master’s preferred.
- 8+ years relevant experience, including bioanalytical and toxicology within GLP/GCP/GCLP.
- Preferred: assay development/validation experience; biomarker assay familiarity (e.g., PCR, ELISA, FISH).
- Prior experience in risk-based QA/auditing/QMS elements and managing quality escalations.
- Expertise in global GLP/GCP/GCLP regulations (e.g., FDA, PMDA, EU, MHRA).
Compensation/Benefits (as stated)
- U.S. pay range: $164,500–$222,500.
- Eligible for annual short-term incentive and annual long-term incentive.
- Total Rewards include medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, and recharge breaks.
The Early Development Quality Lead provides strategic quality oversight of internal and outsourced activities supporting nonclinical studies (GLP/non-GLP) and IND-enabling work, including biomarker utilization in development programs.
Key Responsibilities
- Set strategic quality oversight for internal and outsourced lab activities (toxicology, bioanalytical, biomarker data supporting IND).
- Establish/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 QMS and external standards (GCP, GLP, ICH, OECD).
- Lead risk-based vendor oversight and global audit program; execute audits aligned with GCP/GLP yearly audit plan.
- Support management of outsourced lab quality issues (quality events, significant issues, CAPA oversight).
- Serve as quality escalation point for CRO/vendor issues; lead governance to mitigate emerging compliance risks.
- Provide strategic direction for evaluating CRO/vendor processes and process improvements.
- Drive QMS process improvement in early development/research; partner with Legal/Procurement on contractual oversight language.
Qualifications
- Life sciences (or related) education preferred; Master’s preferred.
- 8+ years relevant experience, including bioanalytical and toxicology within GLP/GCP/GCLP.
- Preferred: assay development/validation experience; biomarker assay familiarity (e.g., PCR, ELISA, FISH).
- Prior experience in risk-based QA/auditing/QMS elements and managing quality escalations.
- Expertise in global GLP/GCP/GCLP regulations (e.g., FDA, PMDA, EU, MHRA).
Compensation/Benefits (as stated)
- U.S. pay range: $164,500–$222,500.
- Eligible for annual short-term incentive and annual long-term incentive.
- Total Rewards include medical/dental/vision, life/disability, lifestyle reimbursement, flexible spending/HSAs, 401(k) match, paid time off, wellness days, holidays, and recharge breaks.