The Senior Director of Quality Control has full accountability and responsibility for staff and GMP laboratory operations including the activities and strategies supporting early through late stage Alnylam programs. This position plays an integral role in various phases of the commercialization process and requires experience in applying cGMPs and regional regulations to meet deliverables, business and regulatory expectations.

The Senior Director is responsible for ensuring operations are maintained in a compliant state and have significant experience in team management, analytical methods, and tools used for monitoring and assessing the quality attributes of raw materials, drug substance, intermediates, and drug product. Experience in development, establishment, management, and defense of QC systems, both internally and externally, with proven communication skills is critical to the role.

Key Responsibilities (including but not limited to):

• Lead the development, implementation, and management of a comprehensive Quality Control operating strategy and management plan
• Lead and ensure a QC system that assures all aspects of QC testing are in compliance with CMC requirements and SOPs
• Provide strategic guidance for regulatory submissions, ensuring accurate representation of QC methodologies and compliance with regulatory standards (e.g., authorship of and contributions to CMC sections and responses to questions); ensure adherence to submissions and consistency between all testing sites
• Oversee operations of all internal and external QC testing activities
• Provide strategic and technical input and guidance as needed
• Represent QC organization in interactions with stakeholders (e.g. Manufacturing, Regulatory Affairs, Supply Chain, Finance, etc.) and Partners (external alliances)
• Represent QC during audits and Health Agency interactions, partner with other functional areas on due diligence evaluations, and contribute to regulatory submissions
• Oversee and provide directional steer for QC systems including data and sample management, routine and non-routine testing, digital excellence (LIMS, equipment, etc), method lifecycle management, and investigations
• Develop and manage a comprehensive budget for QC activities
• Staff strategically. Provide mentorship to team and maintain clear communication on performance, roles and responsibilities.
• Cultivate a high-performing Quality Control team, emphasizing team development, performance excellence, and a collaborative work environment
• Champion the advancement of QC capabilities, including business processes, laboratory methodologies, and the operational model, serving as a key agent of change within the department
• Promote collaboration between the QC department and other organizational functions, including CMC Development, Manufacturing, Manufacturing Technical Services, Supply Chain, Regulatory, and Quality Assurance, to ensure alignment with overall business goals

Qualifications

• B.S. in chemistry, biology, or biochemistry, or related scientific field; advanced degrees considered
• Pharmaceutical/Biotech industry experience with at least 12 years in a GMP Quality Control function, with at least 8 years in a leadership role managing multifaceted GMP functions
• Current knowledge of industry trends, technology advancements or direction, and regulatory requirements (e.g., FDA, EMA, regional compendia, etc.);
• Strong data analysis skills capable of interpreting diverse data sets to influence decision-making;
• Experience with technology transfer, method lifecycle management, and process monitoring
• Direct experience working with contract testing laboratories and manufacturing (CDMO) and/or technical service partners.
• Technical experience leading and providing guidance on OOS/Atypical investigations, deviations, change controls, and CAPAs
• Strong communication skills, written and verbal, to effectively articulate complex technical concepts to diverse audiences;
• Excellent interpersonal skills with proven ability to build relationships, influence stakeholders, and drive collaborative efforts cross-functionally
• Expert knowledge in phase-appropriate approach to compliance and in GMP quality systems and regulatory compliance.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.