Associate Director, Product Quality Assurance

Position Overview:

The Associate Director of Product Quality for Cell and Gene Therapy Programs will act as a leader in the Quality organization and will support the quality aspects of Beams programs over the holistic product lifecycle. This position acts as a Quality Leader by supporting Product Quality Leads (PQLs) on program and CMC-focused deliverables and is a strategic partner with CMC functional areas across the product lifecycle.

This position will have a direct impact on the product quality strategy and overall lifecycle management aspects, from an end-to-end quality perspective (development to post-commercialization). Working closely with the assigned PQLs, the role supports consistency and quality of content and product strategy across the CMC spectrum including review of CMC technical content provided for global clinical and commercial regulatory submissions as well as associated quality records.

Responsibilities:

• Provides strategic Quality CMC-focused support based on Program Team timelines, milestones, and regulatory commitments.
• Drives and takes action on Phase Appropriate Quality strategy for Beams products.
• Performs Quality review/approval of records and documentation related to manufacturing such as process defining documentation.
• Performs product quality impact assessments for product complaints, manufacturing deviations, OOT/OOS results, MRB, adverse trends, etc.
• Quality reviewer and approver of select technical documents (e.g. complaints, temperature excursion reports, justification of specification (JoS), specifications, method validations, critical quality attribute (CQA) assessment, comparability, risk assessments, continued process verification (CPV), tech transfer, ad hoc testing / characterization protocols, etc.)
• Ad hoc Quality representative on Program Team and CMC Team in support of primary PQL.
• Ensures alignment with regulatory requirements, industry standards / best practices, and Beam initiatives.
• Support clinical to commercial analytical control strategy.
• Strategic and technical support across product lifecycle (manufacturing process and analytical method changes, tech transfer, characterization, comparability, validations, technology improvements, etc.).
• Reviews manufacturing process performance, analytical method performance, stability data, etc. for signals / trends / patterns to proactively monitor and if necessary, support mitigations.
• Authors annual product quality reviews.
• Responds to compliance & quality related troubleshooting activities.
• Supports expiry extensions in collaboration with QC.
• Assists in the implementation of quality systems and procedures/SOPs as needed.
• Enables alignment of product transition from clinical to commercial phase and tech transfers between sites.
• Proposes product improvement activities related to overall quality and compliance strategy.
• Quality reviewer for select CMC technical content provided for global clinical and commercial regulatory submissions.
• Support due diligence audits, site selection, and qualification of external partners as necessary.
• Supports other members of the Quality Team and organization.
• Supports Quality Risk Management (QRM) program.
• Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelors or Advanced degree in scientific discipline.
• 12+ years experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality with at least 4 years of which should have been in a CMC-focused position in Cell and Gene Therapy Quality role.
• Detailed knowledge and understanding of GMP regulations and Food and Drug Administration (FDA) requirements.
• Ability to influence without direct authority.
• Ability to develop into a primary PQL for Beam programs.
• Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions.
• Experience interacting with regulatory health authorities at pre- and post-approval inspection.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent listening, communication and interpersonal skills fostering team spirit.
• Consistent delivery of high-quality work at all times.
• Candidates are expected to come onsite to our Cambridge, MA site 1-3 days per week.