Quality Site Head
Alnylam Pharmaceuticals
August 06, 2026
On-site
Norton, MA
Operations
Key Responsibilities (including But Not Limited To)
- Serve as the site Quality Head, driving strategy, planning and operations for the site Quality organization.
- Serve as the senior site Quality decision-maker for critical compliance, investigations and risk management matters, with ultimate accountability for product disposition.
- Ensure compliant and timely testing and release of commercial and clinical product.
- Lead all GMP Quality functions for the Norton Manufacturing Facility (Quality Assurance, Quality Control, Site Quality Systems, compliance, validation oversight, inspection readiness).
- Ensure robust and 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 manufacturing operations.
- Partner cross-functionally with Manufacturing, Manufacturing Technical Services, Engineering, Supply Chain, Regulatory Affairs, and CMC Development.
- Drive operational excellence via quality systems, metrics, governance, escalations, and continuous improvement.
- Maintain continuous inspection readiness and lead interactions with regulatory agencies, partners, and auditors.
- Oversee Quality owned work products (deviations, investigations, CAPAs, change controls, data integrity, lab operations, computerized systems, supplier quality).
- Develop 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 the key Quality Operations designee.
Qualifications
- Bachelor’s degree in a scientific field (chemistry/engineering); advanced degree preferred.
- 15+ years of progressive GMP Quality leadership in pharma/biotech.
- Deep knowledge in chemistry and leading commercial Quality Control (preference: oligonucleotide, antibodies, or peptides).
- 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, and global GMP requirements.
- Strong regulatory inspection experience with Health Authorities.
- Experience leading investigations, quality risk management, CAPA systems, and continuous improvement.
- Strong operational/business acumen; ability to balance compliance and execution.
- Exceptional leadership, communication, influencing; ability to lead through complexity and change.
- Proven ability to build high-performing teams and a culture of accountability and excellence.
- Proven experience leading Quality Assurance and Quality Control is preferred.
- Serve as the site Quality Head, driving strategy, planning and operations for the site Quality organization.
- Serve as the senior site Quality decision-maker for critical compliance, investigations and risk management matters, with ultimate accountability for product disposition.
- Ensure compliant and timely testing and release of commercial and clinical product.
- Lead all GMP Quality functions for the Norton Manufacturing Facility (Quality Assurance, Quality Control, Site Quality Systems, compliance, validation oversight, inspection readiness).
- Ensure robust and 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 manufacturing operations.
- Partner cross-functionally with Manufacturing, Manufacturing Technical Services, Engineering, Supply Chain, Regulatory Affairs, and CMC Development.
- Drive operational excellence via quality systems, metrics, governance, escalations, and continuous improvement.
- Maintain continuous inspection readiness and lead interactions with regulatory agencies, partners, and auditors.
- Oversee Quality owned work products (deviations, investigations, CAPAs, change controls, data integrity, lab operations, computerized systems, supplier quality).
- Develop 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 the key Quality Operations designee.
Qualifications
- Bachelor’s degree in a scientific field (chemistry/engineering); advanced degree preferred.
- 15+ years of progressive GMP Quality leadership in pharma/biotech.
- Deep knowledge in chemistry and leading commercial Quality Control (preference: oligonucleotide, antibodies, or peptides).
- 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, and global GMP requirements.
- Strong regulatory inspection experience with Health Authorities.
- Experience leading investigations, quality risk management, CAPA systems, and continuous improvement.
- Strong operational/business acumen; ability to balance compliance and execution.
- Exceptional leadership, communication, influencing; ability to lead through complexity and change.
- Proven ability to build high-performing teams and a culture of accountability and excellence.
- Proven experience leading Quality Assurance and Quality Control is preferred.