Lead Specialist, QA Validation

About the role

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The Role:

ElevateBio is looking for a Lead QAV Specialist to provide QA oversight for the BaseCamp Waltham Commissioning, Qualification, and Validation activities. In this role the Lead will be responsible for managing cGMP compliance from a Quality Assurance prospective of validation master plans, project validation plans, facility commissioning/qualification, utility commissioning/qualification, process equipment qualification, and lab equipment and instrument qualification. In addition, this position will support all risk assessments, technical reports, change controls, deviations and CAPAs related to commissioning, qualification, and validation activities. The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.

Here’s What You’ll Do:

- Leads QA partnership for operational activities for Engineering groups (i.e. commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories). Recognized as quality expert for these programs and acts as direct escalation pathway for teams.

- Leads QA oversight of quality events for ongoing validation and engineering operations (equipment upgrades, deviations, and related CAPAs). Scope inclusive of manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.

- Independently evaluates CQV change controls by authoring impact assessments and provides QA support and approval for associated CQV activities.

- Leads QA oversight for CMMS, collaborates with Engineering and Lab and Site Services to evaluate Quality impact for database modification requests.

- Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.

- Potential to provide administration support for Kneat electronic validation system.

- Leads QA oversight and support for periodic review and requalification activities.

- Manage team of QAV personnel including both FTE and contractor resources

- QA SME for Equipment Relocation program, supports all relocation activities that arise due to ongoing manufacturing needs.

Requirements:

- Bachelor’s degree and at least 5 years of related experience; or Master’s degree with at least 3 years of related experience; or a PhD with up to 1 year of related experience.

- Strong knowledge of 21 CFR, ICH, EU regulations

- Prior experience in Cell and Gene Therapy manufacturing a plus.