The Manager, QA Operations will be responsible for leading Quality's oversight of laboratory and manufacturing 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 support plant start-up, material onboarding, and routine operations thereafter to ensure that systems and processes are maintained to ensure compliance to Good Manufacturing Practices, and ultimately to Good Distribution Practices as the programs move to the commercial phase. The role will cover aspects of the QA Operations team, supporting material onboarding processes, release of incoming raw materials and consumables, approval of OOS investigations and test data review, approval of validation protocols, supporting product disposition, approval of associated deviation / investigations, Plant floor Quality presence in manufacturing and/or QC laboratories, and batch documentation review. The role will focus on material management and quality support of QC operations with opportunities to grow and cross train across future modalities and programs. The position will report into Beam NC, QA Operations Director.
The Manager, QA Operations is expected to be an on-site resource for project start-up and routine clinical and commercial operations.
- Individual will partner with other functional areas for site start-up activities, quality risk management, ongoing continuous improvement and future scale-up as well as for problem resolution.
- Assist in building a team which will provide QC operations oversight and quality oversight of manufacturing laboratory activities including plant presence during operations.
- Responsible to ensure GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations.
- Responsible for assisting with materials management processes:
- Supporting the supplier quality management program (identifying, communicating, auditing suppliers)
- Approving material specifications
- Releasing incoming raw materials and consumables
- Responsible for quality oversight of QC operations:
- Approval of OOS investigations, deviations, change controls, and CAPAs
- Test data review, when applicable
- Assisting with product disposition activities of supply produced at the manufacturing facility, which may include review of batch records and labels, and review and approval of manufacturing discrepancies.
- Aid in the development and ongoing improvement of applicable quality systems for the site; identifying gaps or improvements, authoring and approval of procedures, and providing training.
- Review and approve validation protocols, calibration and maintenance work orders and asset inductions.
- Provide Quality support towards resolution of material, product, environmental, facility and equipment manufacturing issues.
- Responsible for supporting functional and facility goals and objectives.
- Responsible for supporting and contributing to quality metrics for the facility.
- Responsible to support and participate in regulatory inspections.
- Responsible for communicating escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or the company brand image to senior management.
- Provide leadership, guidance, and direction to staff consistent with GMP.
- Bachelors or Advanced degree in a scientific discipline.
- 10-12+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality. Knowledge of analytical testing, aseptic processing, and/or cell and gene therapy is preferred.
- 2+ years of Quality leadership experience.
- Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
- Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
- Experience interacting with regulatory health authorities inspections.
- 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.
- Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.