Manager, Quality Assurance (Process Team)

Your Role: Manager, QA (Process Team)

Responsibilities:
- Lead and develop a high-performing QA team, focusing on technical capability, problem-solving, and independent quality oversight
- Provide QA oversight across process teams (Filling, Bacterins/Media, Virus/Cell, Blending/Equipment Prep, Quality Control) ensuring GMP compliance
- Manage quality systems and lifecycle events (Deviations, CAPAs, Change Controls) within Veeva, ensuring timely and compliant execution
- Support audits (internal, corporate, regulatory) and lead investigation, root cause analysis, and CAPA effectiveness
- Drive operational excellence through Gemba walks, quality metrics, and cross-functional collaboration to improve Right First Time (RFT) performance

Qualifications:
- Education: Associate degree required; bachelor’s degree in a science-related field preferred
- Required Experience: Minimum of 5 years in regulated pharmaceutical or vaccine manufacturing
- Required Skills: Strong GMP/regulatory knowledge (FDA/USDA, aseptic processing) and leadership capability in developing technical teams

Preferred Qualifications:
- Experience with SAP, Veeva, and Microsoft Office
- Prior APHIS/USDA submissions and Outline of Production review experience
- Knowledge of Lean/Six Sigma methodologies
- Experience influencing cross-functional teams and driving quality culture initiatives
- Strong background in audit readiness and regulatory inspections

Additional Information:
- Travel: Minimal
- Location: Fort Dodge, IA Manufacturing Site

Benefits and Perks (highlights):
- Multiple relocation packages; two weeklong shutdowns (mid-summer and year-end) plus PTO; 8-week parental leave; 9 Employee Resource Groups; annual bonus offering; flexible work arrangements; up to 6% 401K matching