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ElevateBio Verified
Biotechnology Research

Lead Specialist, QA Validation

Waltham, MAOnsiteFull TimeLeadPosted 1 month agoVisa sponsorship available

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Required skills

  • cGMP
  • 21 CFR
  • ICH
  • EU regulations
  • Technology Transfer
  • Process Validation
  • Risk Assessment
  • Process Characterization

Nice to have

  • CMC
  • client facing

Role summary

ElevateBio is seeking a Lead Specialist, Quality Assurance Validation (QAV) to manage cGMP compliance for technology transfer, manufacturing runs, raw material introduction, method validation, and process validation. This role involves supporting risk assessments, technical reports, change controls, discrepancies, and CAPAs. The candidate will act as QA Lead on cross-functional teams, provide QA oversight for transfer plans, protocols, and reports, and review master batch records and sampling plans. Strong knowledge of 21 CFR, ICH, EU regulations, technology transfer, process validation, and technical writing is required. Prior experience in Cell and Gene Therapy Manufacturing is essential. Prior experience with CMC and client-facing roles are a plus.

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.
  • Prior management experience a plus.
  • Experience in new facility commissioning and qualification preferred.
  • Experience with Blue Mountain CMMS system desired.
  • Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS)
  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk-based decisions.
  • A team player, who listens effectively and invites response and discussion.
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner.

    • Physical and Environment Requirements:

  • Ability to stand, walk, bend and stretch for extended period of time
  • Ability to lift 15-20 lbs
  • Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.
  • Ability to perform routine repetitive motions with use of arms, wrists and hands

    • The budgeted range for this position is $50/hour - $69/hour. This range is a good faith estimate of the expected hourly range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.

    ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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