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Role Summary:

The Senior Director, Quality Control leads the strategy and execution of Quality Control activities that support clinical and commercial manufacturing, pipeline advancement, and product lifecycle management. This role ensures global GMP compliance, inspection readiness, and robust analytical support across external testing laboratories, including release and stability testing.

The Senior Director partners closely with contract manufacturing and testing organizations and collaborates across Analytical and Process Development, Manufacturing, Quality Assurance, Supply Chain, Regulatory Affairs, and Project Management to advance quality and business objectives.

This position is based in Waltham, MA and is not eligible for remote work.

Primary Responsibilities Include:

QC Strategy, Compliance, and Regulatory Readiness

• Define and execute the Quality Control strategy in alignment with quality and business objectives.
• Ensure contract testing laboratories meet global GMP requirements and maintain inspection readiness.
• Represent Quality Control during regulatory inspections.
• Author, review, and approve analytical Chemistry, Manufacturing, and Controls sections of Investigational New Drug applications, Biologics License Applications, and Marketing Authorization Applications.
• Evaluate and implement effective tools for analytical data review, statistical analysis, stability assessment, and expiry assignment.
• Lead internal Specification and Stability Review Boards and facilitate clear, timely, and risk-based decisions.

Technical and Operational Leadership

• Lead the authoring, review, and approval of analytical method transfers, qualifications, and validations.
• Oversee external testing laboratory operations, release and stability testing, and the issuance of Certificates of Analysis.
• Review environmental monitoring, sterility, bioburden, and endotoxin data and participate in related reviews and investigations.
• Lead the establishment and revision of drug substance and drug product specifications, including the development of appropriate scientific and regulatory rationale.
• Lead Quality Control compliance activities, including change controls, corrective and preventive actions, and data integrity initiatives.
• Lead out-of-specification and out-of-trend investigations and ensure appropriate root-cause analysis, corrective actions, and timely resolution.
• Oversee the reference standard program across external testing vendors.

Performance, Analytics, and Vendor Partnership

• Build Quality Control capabilities in stability data analysis, biological assays, and statistical analysis to support evolving portfolio and business needs.
• Analyze laboratory performance and quality metrics and present findings, risks, trends, and recommendations in internal and vendor governance forums.
• Partner with contract manufacturing and testing organizations to align expectations, resolve complex issues, and drive reliable execution.
• Establish clear performance expectations for external laboratories and monitor execution against quality, compliance, and operational objectives.
• Apply sound judgment, situational awareness, collaboration, and negotiation skills to influence outcomes across a highly matrixed environment.
• Collaborate with internal stakeholders to anticipate analytical and Quality Control requirements for clinical development, commercialization, and lifecycle management.

People and Organizational Leadership

• Build and strengthen technical Quality Control capabilities to support corporate goals, pipeline advancement, and future growth.
• Recruit, coach, and mentor team members while supporting professional development and career growth.
• Establish clear priorities, promote accountability, and ensure resources are aligned with functional and organizational objectives.
• Foster an inclusive, collaborative, and high-performing team culture focused on quality, continuous improvement, and results.
• Empower team members and leaders to exercise sound judgment, take ownership of outcomes, and work effectively across functions.
• Promote transparent communication, constructive feedback, and effective collaboration with internal and external partners.

Education and Skills Requirements:

• Bachelor's degree in biology, analytical chemistry, biochemistry, or a related field.
• Advanced degree in chemistry, analytical chemistry, or a related discipline is preferred.
• 15+ years of experience in Analytical Development and Quality Control, or equivalent experience, including significant leadership of people or a function.
• Strong GMP Quality Control background, including experience with compendial and product-specific assays for antibodies and small molecules.
• Strong knowledge of current Good Manufacturing Practices and applicable International Council for Harmonisation, U.S. Food and Drug Administration, and European Union regulations.
• Demonstrated experience overseeing contract testing laboratories, analytical method lifecycle activities, release and stability programs, and inspection readiness.
• Demonstrated experience supporting regulatory submissions and inspections, including the preparation and review of analytical Chemistry, Manufacturing, and Controls content.
• Experience establishing and maintaining drug substance and drug product specifications, stability programs, reference standard programs, and laboratory compliance systems.
• Strong understanding of data integrity requirements, change controls, corrective and preventive actions, and out-of-specification and out-of-trend investigations.
• Demonstrated ability to set functional direction, manage interdependencies, influence senior stakeholders, and translate strategy into execution.
• Proven ability to establish productive relationships and negotiate effectively with contract laboratories, manufacturing organizations, and other external partners.
• Excellent interpersonal, organizational, negotiation, and written and verbal communication skills.
• Ability to operate effectively in a highly matrixed, fast-paced, and evolving environment.
• Sound judgment and the ability to make decisions involving complex technical, compliance, operational, and organizational considerations.

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