Position Overview:

The Associate Director of Product Quality Assurance (PQA) will be responsible for phase appropriate quality oversight of internal and external manufacturing and analytical activities. These activities include analytical testing performed by Beam staff in Cambridge as well as that performed by external partners at contract test labs. Oversight of internal analytical instrument and method qualification/validation is also in scope. Additionally, manufacturing of various products at our CDMOs/external partners is managed as part of this role. The position will be critical to the overall build strategy and growth of the Quality organization for Beam as the company grows and evolves from a Research and Discovery company to a broader organization moving products through the clinical pipeline to commercial launch and growth.

Responsibilities:

• Primary responsibilities encompass all aspects of Quality support for GMP operations. Quality oversight will include external GMP operations (ex. CDMOs, CTLs) and internal analytical operations.
• Responsibilities for quality oversight will also extend to support in other areas of Beam that may support early phase GMP activities.
• Responsible for the core interface and relationship with CDMOs and other external partners from a quality perspective.
• Use sound judgement and critical thinking to develop solutions and drive risk analysis and mitigation strategies.
• Create and ensure appropriate quality systems are in place to support analytical testing and product release in a compliant and timely manner and routinely monitor performance to established targets.
• Ensure appropriate systems are in place for follow up and closing investigations and audit observations.
• Ensure that exceptions are analyzed for corrective preventative actions and product impact.
• Provide technical expertise for quality decisions.
• Evaluate facility, procedures, equipment, personnel and processes to ensure that they consistently deliver product that meets all applicable requirements.
• Oversee all aspects of Quality related to the manufacture of products externally and to the testing of products internally and externally.
• Oversee analytical method and instrument qualification/validation relative to Beam internal testing.
• Provide leadership, guidance, and direction to staff consistent with cGMP.
• Evaluate and sign off on compliance documentation as required.
• Oversee batch record review and assure proper batch release documentation.
• Assure appropriate reviews and approvals for manufacturing and analytical testing records in support of product release.
• Take lead role in organizing and completing investigations, coordinating with other departments involved, and driving closure in a timely manner.
• Provide GxP auditing support for contract service providers.
• Ensure adherence to GxP requirements and SOPs.
• Embody Beam’s cultural values and align daily actions with departmental goals and company culture.

Qualifications:

• Bachelors or Advanced degree in a scientific discipline.
• Typically, 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality. Must have Biologics experience.
• 3+ years of Quality management experience with a successful track record in managing CDMOs as well as internal QA systems in a virtual environment.
• Understanding of worldwide requirements of cGMP and quality systems for commercial and clinical products.
• 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.
• Established expertise and training in GxP systems.
• Ability to evaluate Quality Systems and drive value added enhancements.
• 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 team building, leadership and management skills.
• Excellent listening, communication and interpersonal skills fostering team spirit.
• Consistent delivery of high quality work at all times.
• Outstanding skills in managing vendors and others involved in Quality and Regulatory activities to meet corporate objectives.