QA Validation Manager
MRA Recruiting ServicesWaunakee, WI
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Overview
Schedule
Full-time
Career level
Director
Remote
On-site
Benefits
Paid Holidays
Paid Vacation
Career Development
Job Description
QA Validation ManagerScientific Protein Laboratories (SPL)Waunakee, WI | On-site | Biopharmaceutical ManufacturingLead 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 DoAs 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
- 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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FAQs About QA Validation Manager Jobs at MRA Recruiting Services
What is the work location for this position at MRA Recruiting Services?
This job at MRA Recruiting Services is located in Waunakee, WI, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at MRA Recruiting Services?
Employer has not shared pay details for this role.
What employment applies to this position at MRA Recruiting Services?
MRA Recruiting Services lists this role as a Full-time position.
What experience level is required for this role at MRA Recruiting Services?
MRA Recruiting Services is looking for a candidate with "Director" experience level.
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