Senior Quality Validation Specialist

Responsibilities

• Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
• Author and maintain the IDMO Site Validation Plan
• Provide Quality oversight of process validation studies and process performance qualifications
• Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification & recertification, cleaning & sanitization, and facility controls
• Proactively identify & resolve technical and compliance issues/gaps
• Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge
• Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations – calibration/maintenance, shutdowns, construction projects, etc.)
• Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
• Act as Quality Engineering Subject Matter Expert for responsible areas/projects during client or regulatory inspections
• Drive continuous improvement and increase efficiency and productivity

Requirements

• Bachelor’s degree in a scientific or engineering discipline
• 5 to 8 years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
• 2+ years of direct experience in quality or validation, and demonstrated knowledge of relevant cGMP regulations
• Excellent knowledge of the regulations for biologics, cell and gene therapy products
• Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is desirable
• Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
• Excellent understanding of risk management and CAPA processes
• Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
• Experience with computerized systems validation (CSV) is a plus.