Lead Specialist, QA Validation

ElevateBio; Waltham (MA); On-site; USD 69,000 - 95,000; Full time

Job summary

ElevateBio seeks a Lead QAV Specialist in Waltham to oversee commissioning, qualification, and validation activities from a QA perspective. You will manage CQV-related master plans, assist with risk assessments, deviations, and CAPAs, and lead a team of QA professionals.

Strong regulatory knowledge and GMP experience are required. The role emphasizes collaboration with Engineering, Lab, and Site Services, with potential Kneat system administration and continual process improvement across CQV

Qualifications

• Bachelor’s degree or higher with related experience; master or PhD acceptable with applicable experience.

Responsibilities

• Lead QA partnership for operational activities for Engineering groups (commissioning, qualification, and validation) for GMP facilities and labs.
• Oversee QA events for validation and engineering operations (equipment upgrades, deviations, CAPAs).
• Evaluate CQV change controls by authoring impact assessments and provide QA support and approval.
• Oversee CMMS quality impact assessments with Engineering and Lab teams.
• Coordinate with project teams to develop project schedules, elevate issues, and track milestones.
• Provide administration support for Kneat electronic validation system as needed.
• Lead periodic review and requalification activities in QA for CQV.
• Manage QA QAV personnel including FTEs and contractors.
• Act as QA SME for Equipment Relocation programs during ongoing manufacturing needs.

Skills

CQV oversight

Quality Assurance

Regulatory compliance

Project coordination

Education

Bachelor’s degree in related field

Tools

Kneat

Veeva

Blue Mountain CMMS

Word

Excel

PowerPoint

Job description

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, elevate 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.