Associate Director, Product Quality Assurance

Responsibilities:
- Provide strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments.
- Drive and implement phase-appropriate Quality strategy for Beam’s products.
- Perform Quality review/approval of manufacturing-related records and documentation (e.g., process defining documentation).
- Conduct product quality impact assessments for complaints, manufacturing deviations, OOT/OOS, MRB, adverse trends, etc.
- Review and approve select technical documents (e.g., temperature excursion reports, justification of specification (JoS), specifications, method validations, CQA assessment, comparability, risk assessments, CPV, tech transfer, and ad hoc testing/characterization protocols).
- Serve as an ad hoc Quality representative on Program and CMC Teams supporting the primary PQL.
- Ensure alignment with regulatory requirements, industry standards/best practices, and company initiatives.
- Support clinical-to-commercial analytical control strategy.
- Provide strategic/technical support across the product lifecycle (process/method changes, tech transfer, characterization, comparability, validations, technology improvements).
- Review manufacturing/process performance, analytical method performance, and stability data for trends and support mitigations.
- Author annual product quality reviews.
- Handle compliance/quality troubleshooting; support expiry extensions with QC.
- Assist with quality systems/SOP implementation as needed.
- Enable clinical-to-commercial transition and site tech transfers.
- Propose product improvement activities related to quality and compliance.
- Review select CMC content for global clinical/commercial regulatory submissions.
- Support due diligence audits, site selection, and qualification of external partners.
- Support Quality Risk Management (QRM) and other assigned tasks.

Qualifications:
- Bachelor’s or advanced degree in a scientific discipline.
- 12+ years in pharma/biotech with drug substance/drug product manufacturing, development and/or quality; at least 4 years in a CMC-focused Cell & Gene Therapy Quality role.
- Detailed knowledge of GMP regulations and FDA requirements.
- Ability to influence without direct authority; ability to develop into a primary PQL.
- Excellent communication skills; detail-oriented; capable of driving change across functions.
- Experience with regulatory health authority interactions pre- and post-approval inspection.
- Customer-service mindset and solution-oriented; strong teamwork and interpersonal skills.
- Onsite requirement: Cambridge, MA, 1–3 days per week.