Lead Specialist, Quality Operations (Contractor)

The job overview for this role is that the QA Lead Specialist will be responsible for providing quality assurance expertise and support for commercial manufacturing and batch disposition activities in the field of gene therapies. They will be involved in external quality relationship development, QA review and approval of technical protocols and reports, as well as the review and approval of manufacturing records. The QA Lead Specialist will also be responsible for resolving quality systems issues and escalations encountered during manufacturing and testing processes. This is a 6-month contract role.

• Provide QA expertise in support of commercial manufacturing and batch disposition activities.
• Provide QA approval of change control ensuring appropriate impact assessments to assure compliance with bluebird bio and industry requirements.
• Provide Quality representation on internal bluebird bio and external CMO/CLO cross functional teams for batch disposition activities, deviation, OOS and change control management.
• Liaise with internal and external teams at bluebird bio CMO’s in support of a bluebird bio commercial product, including alignment with the bluebird bio CMO on release of drug product.
• Utilize in-depth knowledge and understanding of FDA expectations, specifically as they relate to batch disposition and product review.
• Exercise considerable latitude in determining objectives and approaches to critical assignments.

• Bachelors' degree in Scientific field required
• Minimum of five (5) years of experience in the biotech/pharma industry, ideally in QA oversight of commercial manufacturing and batch disposition activities
• Expertise in providing QA approval of change control and ensuring compliance with bluebird bio and industry requirements
• Experience in representing Quality on internal and external cross-functional teams for batch disposition activities, deviation, OOS, and change control management
• Ability to liaise with internal and external teams at bluebird bio CMO's in support of a bluebird bio commercial product, including alignment with the bluebird bio CMO on release of drug product
• In-depth knowledge and understanding of FDA expectations, specifically related to batch disposition and product review
• Ability to exercise considerable latitude in determining objectives and approaches to critical assignments

• Bachelors' degree in Scientific field required
• Minimum of five (5) years of experience in the biotech/pharma industry
• Broad in-depth knowledge and expertise in deviations, CAPAs, and change controls
• Direct experience with disposition of GMP commercial drug products
• Experience interacting with CMOs
• Knowledge of aseptic processing and manufacturing
• Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus
• Self-motivation and organizational skills to manage workload independently
• Equal opportunity employer
• Welcoming and diverse environment