QA Validation Manager

Our Cell Therapy Client in Boston is growing and looking to add a QA Validation Manager to their team!  This role will report to the Director of Quality Assurance, located in Boston, MA and will have some travel to their other facility in TX. The main responsibility will be the management of software and equipment implementation and for the oversight of each program This will mainly focus on GxP related activities but will also support any R&D related qualification. This role will also be involved with supporting the overall Quality Systems management.  Other responsibilities include but not limited to: 

 

  • Work with relevant departments to set-up an equipment management program for lab and GMP manufacturing facility, including but not limited to, equipment validation, calibration, maintenance, and tracking systems.
  • Determine SOPs required and participate in the authoring and/or review of SOPs to support the Equipment Management Program developed.
  • Provide computer validation support for computer system assessments, validation and change control, and provide effective Quality support at all applicable points of the Computerized System Lifecycle (CSLC)
  • Provide expertise in assessing the overall IT program and work with stakeholders to ensure the systems, SOP’s, and overall documentation is sufficient for phase appropriate activities and internal requirements.
  • Perform timely and effective QA review of validation documentation such as Validation Plans, Traceability Matrices, testing deliverables, SOPs, and data migration plans
  • Provide timely updates on IT validation projects and deliverables to Quality Systems management
  • Work in collaboration with Business Owners, IT Owners, and contracted vendors to execute or support Periodic Reviews of Computerized Systems
  • Work with the Vendor management SME to support IT related assessments and/or auditing

 

Requirements: 

  • Bachelor's degree or equivalent education and work experience
  • Professional with a minimum of 10 years of experience in Quality Assurance role in pharma, biopharma/biotech, or healthcare environment
  • Must have proficient computer skills in Microsoft Word, Excel and Outlook.
  • Experience with Software and Equipment Validation
  • Up-to-date on the regulatory requirements for Software and Equipment GMP operations
  • Expertise in compliance with respect to pharmaceutical/biologics Quality Systems and Quality Risk management
  • Skilled in problem solving, root cause analysis, decision-making, and corrective action management
  • Strong interpersonal skills and the ability to work well as part of a team
  • Solid organizational and time management skills
  • Excellent written and verbal communication skills
  • Ability to work independently with minimal supervision
  • Will require travel to TX facility