Quality Assurance Project Manager m/f/d, WallisThe QA Project Manager is responsible for daily oversight, tactical and strategic leadership for a team of QA Project Managers, supporting both internal and external customers.
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.
- Quality Assurance (Advanced Level): 10-15 years.
- Experience in management (Direct Reports)
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