Job: Director, Quality: Quality Assurance Operations, Beam Therapeutics, RTP, NC
The Director, QA Operations will be responsible for the QA oversight of product quality, manufacturing and support operations at Beam’s manufacturing facility in RTP, North Carolina. The NC manufacturing facility is a greenfield build and will build out in various phases over a 6-8 Year period, with a focus on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility will start as a clinical phase manufacturing plant with the intent to move several programs to commercial within the same facility.
The role will build a QA support team for plant start-up and routine operations thereafter to ensure that systems and processes are implemented to ensure compliance to Good Manufacturing Practices, and ultimately to Good Distribution Practices as the programs move to the commercial phase. QA operations functional area will be responsible for Product disposition, Plant floor Quality presence including support for initial Commissioning, Qualification and validation of facilities and equipment, batch record review and approval of associated deviation / investigations, release of incoming raw materials and consumables, QA oversight of the QC laboratory activities including approval for CoA, approval of OOS investigations and test data review as necessary. The position will report into Beam NC, Site Quality Head.
The Director, QA Operations is expected to be on-site resource for project start-up with option for flexible work arrangement with remote work some percentage of time depending on current work assignments.
Individual will act as a leader in the Beam Site Quality organization. As such, the individual will help define, communicate, and drive the Quality vision and mindset of the site in close collaboration with the Site Head of Quality.
Individual will partner with other functional area leaders for site start-up activities, quality risk management, ongoing continuous improvement and future scale-up as well as for complex problem resolution.
Responsible for the product quality of supply produced at the manufacturing facility.
Responsible to build and implement applicable quality systems for the site; ensuring rollout and connection to global systems and processes.
Responsible to build and implement a QA operations team which will have Quality oversight of on the floor activities including plant presence during operations and QC operations oversight.
Responsible to ensure GMP compliance in manufacturing and testing, exception management, and overall product lot review and disposition.
Responsible for facility support GMP compliance activities including Quality oversight of calibration and maintenance procedures as well as review and approval of change controls impacting operational status.
Individual will work and coordinate with other members of the greater quality organization (outside of the NC organization) to assist in developing, implementing, refining, and providing input to the overall Quality Management System (QMS) growth and evolution over time.
Responsible for leaderships responsibilities to meet functional and facility goals and objectives.
Responsible to assist in implementation of quality metrics for the facility and ensure that a management review process is in place.
Responsible to support and participate in external visits and regulatory inspections.
Ensures appropriate escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or the company brand image.
Support due diligence audits, site selection, and qualification of external partners as necessary.
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.
Provide leadership, guidance, and direction to staff consistent with GMP.
Supports other members of the Quality Team and organization during its growth period in aspects not related to the core responsibilities of the QA operations area.
Embodies Beam’s cultural values and aligns daily actions with departmental goals and company culture.
Bachelors or Advanced degree in a scientific discipline.
18+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
5+ years of Quality leadership experience.
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.
Solid knowledge of global regulations and standards.
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.