Senior Manager, QA Validation

The Role:

ElevateBio is looking for a Sr. Manager to provide QA oversight and strategy for the BaseCamp Pittsburgh Commissioning, Qualification, and Validation activities. In this role the Sr. Manager 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 with 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:

• Provide QA oversight of commissioning, qualification, and validation activities to the GMP manufacturing facility and quality control laboratories.
• Provide QA oversight and support for periodic review and requalification activities.
• Change control assessment and approval to assure proper impact assessment and sufficient testing to develop and maintain a validated state.
• Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods, and laboratory instruments.
• Manage/complete Quality Risk Assessments (QRA) for facility and engineering activities.
• Support use of the Kneat Paperless Validation system at the BaseCamp Pittsburgh facility.

Requirements:

• Bachelor’s degree in engineering, life sciences or related field with 7+ years of validation and/or quality assurance 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 Kneat paperless validation 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.