Quality Site Head
Alnylam Pharmaceuticals
June 24, 2026
On-site
Norton, MA
Operations
Key Responsibilities:
- Serve as the Site Quality Head, driving strategy, planning, and operations for the site Quality organization.
- Be the senior decision-maker for critical compliance, investigations, and risk management; accountable for product disposition.
- Ensure compliant and timely testing and release of clinical and commercial product.
- Lead all GMP Quality functions for the Norton Manufacturing Facility (Quality Assurance, Quality Control, Site Quality Systems, compliance, validation oversight, and inspection readiness).
- Ensure scalable Quality Management Systems meeting FDA, EMA, ICH, and global regulatory expectations.
- Provide Quality leadership for facility start-up, commissioning, qualification, validation, PPQ, technology transfer, and ongoing operations.
- Act as cross-functional Quality partner with Manufacturing, MTS, Engineering, Supply Chain, Regulatory Affairs, and CMC Development.
- Drive operational excellence via quality systems, metrics, governance, escalation, and continuous improvement.
- Maintain inspection readiness and lead interactions with regulators, partners, and auditors.
- Oversee Quality work products (deviations, investigations, CAPAs, change controls, data integrity, lab operations, computerized systems, supplier quality).
- Develop organizational capability via talent management, succession planning, coaching, and engagement.
- Build and lead a high-performing Quality organization for expanding clinical/commercial operations.
- Contribute to enterprise strategy as Quality Operations designee.
Qualifications:
- Bachelor’s degree in a scientific field (chemistry/engineering); advanced degree preferred.
- 15+ years progressive GMP Quality leadership in pharma/biotech.
- Deep expertise in chemistry and leading commercial Quality Control (preference: oligonucleotides, antibodies, or peptides).
- Proven success driving site start-up, commercialization, validation, and GMP manufacturing/testing.
- Demonstrated Site Quality Head capabilities (commercial operations preferred).
- Deep knowledge of FDA/EMA/ICH/global GMP requirements.
- Strong regulatory inspection experience with Health Authorities.
- Experience with complex investigations, quality risk management, CAPA systems, and continuous improvement.
- Strong operational/business acumen; balances compliance and execution.
- Exceptional leadership, communication, and influencing; leads through complexity and growth.
- Proven ability to build high-performing teams and a culture of accountability/collaboration/excellence.
- Experience leading both Quality Assurance and Quality Control (preferred).
Benefits:
- $276,300.00–$373,800.00 base pay range; eligible for annual short-term incentive and annual long-term incentive.
- Medical, dental, vision; life and disability; lifestyle reimbursement; flexible spending/HSAs; 401(k) match; paid time off, wellness days, holidays, and two recharge breaks.
Application instructions:
- Learn more about benefits at https://www.alnylam.com/careers
- Serve as the Site Quality Head, driving strategy, planning, and operations for the site Quality organization.
- Be the senior decision-maker for critical compliance, investigations, and risk management; accountable for product disposition.
- Ensure compliant and timely testing and release of clinical and commercial product.
- Lead all GMP Quality functions for the Norton Manufacturing Facility (Quality Assurance, Quality Control, Site Quality Systems, compliance, validation oversight, and inspection readiness).
- Ensure scalable Quality Management Systems meeting FDA, EMA, ICH, and global regulatory expectations.
- Provide Quality leadership for facility start-up, commissioning, qualification, validation, PPQ, technology transfer, and ongoing operations.
- Act as cross-functional Quality partner with Manufacturing, MTS, Engineering, Supply Chain, Regulatory Affairs, and CMC Development.
- Drive operational excellence via quality systems, metrics, governance, escalation, and continuous improvement.
- Maintain inspection readiness and lead interactions with regulators, partners, and auditors.
- Oversee Quality work products (deviations, investigations, CAPAs, change controls, data integrity, lab operations, computerized systems, supplier quality).
- Develop organizational capability via talent management, succession planning, coaching, and engagement.
- Build and lead a high-performing Quality organization for expanding clinical/commercial operations.
- Contribute to enterprise strategy as Quality Operations designee.
Qualifications:
- Bachelor’s degree in a scientific field (chemistry/engineering); advanced degree preferred.
- 15+ years progressive GMP Quality leadership in pharma/biotech.
- Deep expertise in chemistry and leading commercial Quality Control (preference: oligonucleotides, antibodies, or peptides).
- Proven success driving site start-up, commercialization, validation, and GMP manufacturing/testing.
- Demonstrated Site Quality Head capabilities (commercial operations preferred).
- Deep knowledge of FDA/EMA/ICH/global GMP requirements.
- Strong regulatory inspection experience with Health Authorities.
- Experience with complex investigations, quality risk management, CAPA systems, and continuous improvement.
- Strong operational/business acumen; balances compliance and execution.
- Exceptional leadership, communication, and influencing; leads through complexity and growth.
- Proven ability to build high-performing teams and a culture of accountability/collaboration/excellence.
- Experience leading both Quality Assurance and Quality Control (preferred).
Benefits:
- $276,300.00–$373,800.00 base pay range; eligible for annual short-term incentive and annual long-term incentive.
- Medical, dental, vision; life and disability; lifestyle reimbursement; flexible spending/HSAs; 401(k) match; paid time off, wellness days, holidays, and two recharge breaks.
Application instructions:
- Learn more about benefits at https://www.alnylam.com/careers