Associate Director, Quality Control

• Lead Quality Control activities supporting clinical and commercial drug substance and drug product programs in accordance with ICH and cGMP requirements
• Manage master specifications for starting materials, reference standards, API, and drug products
• Lead stability activities, including trending, statistical evaluation, scientific interpretation, shelf-life extensions, expiry dating justifications, and emerging risk evaluation
• Manage stability studies and monitor stability data for reference standards, API, and drug products
• Lead OOS and OOT investigations and draft reports with internal teams and external testing laboratories
• Review and manage analytical and non-analytical results for product release and stability
• Organize and file quality control data, protocols, and reports
• Manage reference standard qualification and distribution through external laboratories
• Lead quality control checks on CMC sections of IND, CTA, and NDA submissions
• Manage review and approval workflows for feasibility/comparability studies, validation protocols and reports, and test methods
• Collaborate with QA on release documents, including Certificates of Analysis and Certificates of Testing
• Manage relationships with external laboratories and CMOs; participate in remote audits and perform onsite audits as required
• Collaborate with Drug Product and API groups to optimize clinical trial material deliverables
• Support transfer of new drug candidates from research/discovery to CMC drug development
• Oversee sample movement between testing partners and CMOs for tech transfers, release, and stability testing
• Assess team capacity and lead assigned teams to meet project deliverables, including performance reviews
• Ensure compliance with deviations, change controls, and CAPAs
• Recruit, lead, develop, coach, and evaluate direct reports as applicable
• Ensure adherence to company policies and Code of Business Conduct and Ethics
• Travel internationally as required

• Undergraduate degree in life sciences
• 8+ years of relevant management experience in the pharmaceutical industry
• Experience with small molecules and/or biologics
• Experience working with external testing laboratories
• Ability to work independently and influence in a fast-paced environment
• Strong quality mindset
• Comfort working across locations and time zones
• Strong experience with quality control testing
• Experience managing stability programs in accordance with ICH guidelines
• Experience with master specifications
• Experience with method validations
• Experience with OOS/OOT investigations
• Experience with batch release processes
• Experience with quality management systems
• Experience auditing external laboratories, FDA/EMA inspections, and inspection readiness preferred
• Prior experience with IND, BLA, and/or CTA CMC submissions preferred
• Knowledge of cGMP and US, Canadian, and EU regulatory environments
• Excellent oral and written communication skills
• Previous team leadership experience
• Willingness to travel up to 20% domestically and internationally
• Ability to work onsite at the Boston office at least 2 days per week

Demonstrates extensive experience in leading Quality Control activities in compliance with ICH and cGMP requirements, managing stability programs, and overseeing analytical results for drug substance and product programs. Proven ability to collaborate across teams and manage relationships with external laboratories while ensuring adherence to regulatory standards.

• Quality Control Testing
• Stability Program Management
• OOS/OOT Investigations
• IND, BLA, CTA CMC Submissions
• CGMP Compliance

• Quality Management Systems
• Method Validations
• Master Specifications
• Statistical Evaluation
• Analytical Results Review
• Batch Release Processes
• Stability Data Monitoring
• Reference Standard Qualification
• CAPA Management
• Deviation Management

• Strong Quality Mindset
• Excellent Oral Communication
• Excellent Written Communication
• Team Leadership
• Influencing Skills

• Pharmaceutical Industry
• ICH Guidelines
• CGMP
• FDA Inspections
• EMA Inspections
• Clinical Trial Material
• External Laboratories
• CMOs
• Regulatory Environments
• Quality Control Activities