Director of Quality Assurance | Pharmaceutical Manufacturing
We’re currently seeking an experienced Director of Quality Assurance to lead Quality Systems, Clinical Quality and Manufacturing Quality within a growing pharmaceutical organization.
This is a senior leadership opportunity for a quality professional who can drive GxP compliance, quality strategy and continuous improvement across development, manufacturing and commercialization.
Key responsibilities:
- Lead Quality Systems, Clinical Quality and Manufacturing Quality
- Provide strategic direction across CAPA, Change Control, Supplier Quality, Audits, Risk Management and Product Disposition
- Lead regulatory inspection readiness and act as a key contact during FDA and international inspections
- Oversee quality activities with CMOs, suppliers and third-party laboratories
- Drive a strong quality culture and continuous improvement across the organization
- Lead, develop and coach the Quality Assurance team
- Manage quality strategy, metrics and departmental budgets
About you:
- Bachelor’s degree required; advanced scientific/engineering degree preferred
- 7+ years’ experience within a regulated GxP/pharmaceutical manufacturing environment
- Proven leadership and people management experience
- Strong knowledge of pharmaceutical manufacturing and GxP requirements
- Strategic thinker with excellent problem-solving, communication and decision‑making skills
Director of Quality Assurance in indiana at Unknown Company
This position is listed as full time and onsite.