Quality Assurance Project Manager

Leadership & Oversight

• Provide guidance, support, and leadership to ensure QA Project Managers deliver quality support to internal and external customers.
• Define and set the model for superior customer service.
• Act as a point of escalation for QA staff and customers.
• Develop team goals and drive continuous improvement, efficiency, and innovative thinking.
• Oversee training, mentoring, and development in Quality principles.
• Conduct performance reviews, provide feedback, and support career development.
• Interview and hire personnel, ensuring capable and experienced staff.

Quality & Compliance

• Ensure quality deliverables (e.g., sterility assurance assessments) are achieved at key milestones during tech transfer (TT) and process validation.
• Oversee material assessments, process validation execution, TT production issues, deviations, change controls, regulatory compliance, and quality agreements.
• Manage and track Key Performance Indicator (KPI) quality metrics for both internal and external customers.
• Train and lead the team in identifying, resolving, and documenting quality issues.
• Assess risk and provide compliant, effective, and efficient solutions.
• Support completion of QA deliverables related to lot disposition, change controls, and root cause analysis on deviations.
• Prepare deviation trending reports for senior site management, assess trends, and provide recommendations.

Project & Customer Support

• Serve as QA Project Manager for client projects when required.
• Partner with internal stakeholders (MSAT, Engineering, QC, Validation, Supply Chain, Manufacturing) to review Change Controls, Deviations, CAPAs, and Investigations as the QA Subject Matter Expert.
• Support higher-risk quality issues across site functions.
• Represent QA in site meetings, regulatory inspections, and customer audits.
• Ensure all QA objectives and deliverables are aligned with Quality Agreements, SOPs, and applicable regulations.

Requirements:

• BSc/MSc in Science, Biotechnology, or related discipline.
• Specific tools or systems required (e.g. SAP, TrackWise, Veeva)
• Quality Assurance (Advanced Level): 10–15 years.
• Experience in management (Direct Reports)