Manager, Quality Assurance Operations

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 role will support plant start-up, material onboarding, and routine operations to ensure compliance to Good Manufacturing Practices. The Manager 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 and is expected to be an on-site resource for project start-up and routine clinical and commercial operations.

• Lead Quality's oversight of laboratory and manufacturing operations at Beam's manufacturing facility in RTP, North Carolina
• Support plant start-up, material onboarding, and routine operations to ensure compliance to Good Manufacturing Practices
• Cover aspects of the QA Operations team, including 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, and batch documentation review
• Focus on material management and quality support of QC operations
• Partner with other functional areas for site start-up activities, quality risk management, continuous improvement, and future scale-up
• Assist in building a team to provide QC operations oversight and quality oversight of manufacturing laboratory activities
• Ensure GMP compliance in QC, manufacturing, and facilities operations
• Support the supplier quality management program, approve material specifications, and release incoming raw materials and consumables
• Provide quality oversight of QC operations, including approval of OOS investigations, deviations, change controls, and CAPAs, and test data review
• Assist with product disposition activities and review of batch records and labels
• Aid in the development and improvement of quality systems for the site, including identifying gaps or improvements, authoring and approving procedures, and providing training
• Review and approve validation protocols, calibration and maintenance work orders, and asset inductions
• Provide quality support for resolution of material, product, environmental, facility, and equipment manufacturing issues
• Support functional and facility goals and objectives
• Contribute to quality metrics for the facility

• Experience in leading Quality's oversight of laboratory and manufacturing operations
• Knowledge of Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
• Familiarity with advanced therapeutic manufacturing technologies, specifically cell and gene therapy modalities
• Ability to support plant start-up, material onboarding, and routine operations
• Proficiency in material management and quality support of QC operations
• Strong understanding of quality risk management and continuous improvement processes
• Experience in supplier quality management, including identifying, communicating, and auditing suppliers
• Ability to approve material specifications and release incoming raw materials and consumables
• Knowledge of OOS investigations, deviations, change controls, and CAPAs
• Ability to review and approve validation protocols, calibration and maintenance work orders, and asset inductions
• Strong problem-solving skills for resolving material, product, environmental, facility, and equipment manufacturing issues
• Ability to contribute to the development and improvement of quality systems
• Strong attention to detail for reviewing batch records, labels, and manufacturing discrepancies
• Ability to support and contribute to quality metrics for the facility

• Competitive salary and benefits package
• Opportunity for professional development and growth
• Involvement in the development and improvement of quality systems
• Leadership and management opportunities
• Collaboration with cross-functional teams and external partners
• Exposure to regulatory health authorities inspections
• Work in a fast-paced and dynamic industry
• Flexible schedule during peak times
• Onsite work environment