The Associate Director/Director of GMP Quality Assurance (External) Lead will be responsible for creating/monitoring and maintaining phase appropriate ICH 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 Associate Director/Director of GMP Quality Assurance (External) Lead will have overall responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately in the areas of GMP compliance with Beam’s externally focused manufacturing efforts. Position will also support Beam’s internal groups across the company where quality operations support is required (ex. Quality support in early phase GMP operations that may occur in Beam’s internal groups).
- As a core member of the Quality Team, individual will help define and drive the Quality vision and mindset of the entire company in close collaboration with the Head of Quality and the executive leadership team.
- Primary responsibilities encompass all aspects of Quality support for GMP operations. Quality oversight will primarily encompass external GMP operations (ex. CDMOs).
- 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/external partners from a quality perspective.
- 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.
- 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.
- Oversees batch record audits and assures proper batch release documentation.
- Assures appropriate reviews and approvals of manufacturing and aseptic filling records for execution as well as for product release.
- Takes lead role in organizing and completing investigations, coordinates with other departments involved, and drives 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).
- Ensures adherence to GxP requirements and SOPs.
- Supports QA Documentation & Training Plans/GxP Training Modules with Quality and internal/external stakeholders.
- 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 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.