Manager – Quality Assurance Operations
Confirmed live in the last 24 hours
Beam Therapeutics

501-1,000 employees

Research Triangle, Durham, NC, USA
Experience Level
Desired Skills
Customer Service
Operations & Logistics
Customer Success & Support
  • 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
  • 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