QA Validation Manager
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Job Location:
Waunakee, WI - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 were 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 Youll Do
As the QA Validation Manager youll provide strategic and hands-on leadership across all major validation disciplines ensuring SPLs 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
- Bachelors 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
- Masters 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
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.
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Required Experience:
Manager
Key Skills
- Quality Assurance
- FDA Regulations
- Food Industry
- Food Safety Experience
- ISO 9001
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- QA/QC
- Selenium
- HACCP
About Company
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