QA Validation Manager

MRA Recruiting Services • Waunakee, WI

1d • Onsite

About The Position

QA Validation Manager

Scientific Protein Laboratories (SPL) Waunakee, WI | On-site | Biopharmaceutical Manufacturing Lead validation. Shape quality. Make an impact in life-saving biologics. Scientific Protein Laboratories (SPL) is a global leader in biopharmaceutical manufacturing, supporting the production of critical therapies that improve and save lives worldwide. As we continue to expand our capabilities, we’re seeking a QA Validation Manager to lead enterprise-level validation programs across our Waunakee, WI site. This is a high-visibility leadership role for a validation expert who thrives in regulated environments, enjoys cross-functional collaboration, and wants to influence how validation is done, not just maintain the status quo. What You’ll Do As the QA Validation Manager, you’ll provide strategic and hands-on leadership across all major validation disciplines, ensuring SPL’s validation programs meet the highest standards of quality, compliance, and efficiency. 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 What Success Looks Like 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 What You Bring 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 Why Join SPL? 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 If you’re a validation leader ready to take ownership, influence quality strategy, and work on products that truly matter, SPL wants to hear from you . SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. We Make it Easy Founded in 1901, MRA is a nonprofit employer association that serves more than 4,000 employers, covering more than one million employees. As one of the largest employer associations in the nation, MRA helps its member organizations thrive by offering the most comprehensive assortment of HR services, information, education, and resources to help build successful workplaces and a powerful workforce. We partner with these companies working directly with their HR department and leadership to hire their talent. We are a direct line to the company, not an agency recruiter.

Requirements

• 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

Nice To Haves

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

Responsibilities

• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager