Senior Director, Product Quality Assurance, Cambridge

Position Overview:

The Senior Director, Product Quality Assurance, Cambridge (PQA) will be responsible for creating/monitoring and maintaining phase appropriate levels of compliance in all of our CDMOs/external partners. 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.

The position will have overall responsibility to ensure initiatives related to quality and compliance are optimized and executed appropriately in the areas of GMP compliance with Beams externally focused manufacturing efforts. Position will also provide top level guidance and support on internal GMP activities in the Cambridge location, and globally from a GMP perspective.

Primary Responsibilities:

• Primary responsibilities encompass all aspects of Quality support for GMP operations. Quality oversight will primarily encompass external GMP operations (ex. CDMOs) and QC support in Cambridge.
• Responsibilities for quality oversight will also extend to support in other areas of Beam that may support GMP activities.
• Responsible as a key relationship manager CDMOs/external partners from a quality perspective.
• Works cross-functionally with other members of the greater CMC area and program teams for CDMO selection and vetting.
• Establishes an overall KPI and metrics program to assist in governing the CDMO relationships.
• Establishes a routine process for continuous improvement of the CDMO oversight processes.
• Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies.
• Create and ensure appropriate quality systems are in place to support 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 preventive actions and product impact.
• Provide technical expertise for product 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.
• Oversee Quality support for QC activities in Cambridge, including testing, method qualification/validation, instrument qualification, and quality system records related to QC activities.
• Ensure Quality hands-on oversight of GMP-relevant facilities and equipment in Cambridge.
• Provide leadership, guidance, and direction to staff consistent with cGMP.
• Evaluate and sign off on compliance documentation including approving regulatory filings for designated products as required.
• Oversee external batch record review and ensure proper batch release documentation.
• Assure appropriate reviews and approvals of manufacturing and aseptic filling records for execution as well as for 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 for contract service providers including audit preparation, execution of the audit, the audit report, and follow up to any finding(s).
• Ensure adherence to GxP requirements and SOPs.
• Oversee relationship with Qualified Person (QP) and direct work requiring QP oversight and disposition.
• Embodies Beams cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• Bachelors or Advanced degree in a scientific discipline.
• 15+ years experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality. Must have CT/GT/biologics experience.
• 7+ years of Quality management experience with a successful track record in managing CDMOs as well as internal QA systems in a virtual environment.
• Experience in auditing/vetting of CDMOs.
• 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.