Quality Site Head (Norton)
Overview The Quality Site Head will lead the Quality organization for the Norton Manufacturing and Testing Facility. This role serves as the senior Quality leader for the site, accountable for building and sustaining a high-performing GMP Quality organization, in support of clinical and commercial manufacturing operations.
Reporting to the Vice President, Quality Operations, this individual will lead site Quality Assurance and Quality Control organizations and serve as a core member of the Norton Site Leadership Team. The role is critical to ensuring operational excellence, inspection readiness, compliant and timely product supply, as well as successful execution of facility expansion and commercialization activities.
The ideal candidate is a highly respected GMP Quality leader who combines strategic thinking and innovation with operational execution, to ensure sustained, industry-leading site performance. This individual brings deep experience across manufacturing quality and quality control laboratory operations, including building and leading modern GMP quality systems. The candidate demonstrates sound judgment, an enterprise mindset, executive presence, and the ability to lead through growth, complexity, and organizational change while fostering a culture centered on quality and accountability.
This position is an on-site role based in Norton, MA, with periodic travel to Cambridge and external supplier sites, as needed.
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, including Quality Assurance, Quality Control, Site Quality Systems, compliance, validation oversight, and inspection readiness.
- Ensure robust and scalable Quality Management Systems that meet FDA, EMA, ICH, and global regulatory expectations.
- Provide Quality leadership for facility start-up, commissioning, qualification, validation, PPQ, technology transfer, and ongoing manufacturing operations.
- Acts as the strategic Quality partner cross-functionally with Manufacturing, Manufacturing Technical Services, Engineering, Supply Chain, Regulatory Affairs, and CMC Development.
- Drive operational excellence through effective quality systems, metrics, governance, escalation processes, and continuous improvement initiatives.
- Maintain a continuous state of inspection readiness and lead interactions with regulatory agencies, partners, and auditors.
- Oversee Quality support and is ultimately accountable for Quality owned work products, such as deviations, investigations, CAPAs, change controls, data integrity, laboratory operations, computerized systems, and supplier quality activities.
- Develop organizational capability through strong talent management, succession planning, coaching, and employee engagement.
- Build, develop, and lead a high-performing Quality organization capable of supporting expanding clinical and commercial operations.
- Contribute to broader enterprise strategy as the key Quality Operations designee across strategy initiatives.
Qualifications- Bachelor's degree in a scientific field such as chemistry or engineering; advanced degree preferred.
- 15+ years of progressive GMP Quality leadership experience within the pharmaceutical or biotechnology industry.
- Deep knowledge and expertise in chemistry and leading a commercial Quality Control function, with a preference for experience with oligonucleotide, antibodies, or peptides.
- Demonstrated success driving site start-up, commercialization, validation, and GMP manufacturing and testing operations.
- Demonstrated capabilities as a site Quality Head, with commercial operations preferred.
- Deep knowledge of FDA, EMA, ICH, and global GMP regulatory requirements.
- Strong regulatory inspection experience with demonstrated success interacting with Health Authorities.
- Experience leading complex investigations, quality risk management, CAPA systems, and continuous improvement initiatives.
- Strong operational and business acumen with the ability to balance compliance, execution, and organizational effectiveness.
- Exceptional leadership, communication, and influencing skills with demonstrated ability to lead through complexity and organizational growth.
- Proven ability to build and develop high-performing teams and drive a strong culture of accountability, collaboration, and excellence.
- Proven experience leading both Quality Assurance and Quality Control organizations within a manufacturing environment is preferred.
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U.S. Pay Range$276,300.00 - $373,800.00The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).
Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.
Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers
