QA Validation Manager

Location: Waunakee, WI

• Lead and oversee equipment, process, cleaning, and computerized systems validation within a biologics drug substance manufacturing environment
• Own and maintain the Master Validation Plan (MVP) and validation governance framework
• Develop and execute risk-based validation strategies aligned with cGMP, 21 CFR Part 11, and global regulatory expectations
• Review and approve validation protocols, reports, change controls, deviations, and CAPAs
• Partner closely with Manufacturing, Engineering, Quality, IT, and Regulatory teams to ensure seamless integration of validation activities
• Serve as a subject matter expert during audits, inspections, and regulatory interactions
• Lead continuous improvement initiatives to modernize validation processes and documentation
• Support technology transfer, scale-up, and new product introductions
• Mentor and develop validation team members while managing resources and budgets

• Validation programs are inspection-ready, compliant, and efficient
• Cross-functional teams view you as a trusted technical and quality leader
• Validation strategies evolve with regulatory expectations and industry best practices
• Issues are proactively identified, thoroughly investigated, and effectively resolved

• Bachelor’s degree in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or a related scientific field
• 5+ years of validation experience in a regulated pharmaceutical or biologics environment
• At least 2 years of people leadership or management experience
• Deep expertise across multiple validation disciplines
• Strong knowledge of cGMP and regulatory compliance requirements

• Master’s degree or higher
• 10+ years of validation experience in biologics or complex manufacturing environments

• Meaningful work supporting life-saving biologically based therapeutics used worldwide
• Competitive compensation package including base salary and recognition programs
• 401(k) with company match to support your long-term financial goals
• Generous paid time off (PTO) and paid holidays
• Career development and leadership growth opportunities within a global biopharmaceutical organization
• Collaborative, science-driven culture that values integrity, accountability, and continuous improvement
• High quality of life in Waunakee, WI! A growing community just outside Madison with excellent schools and outdoor recreation

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