Key skills
Leadership
About this role
Role Overview
- Leads preparedness for regulatory inspections ensuring compliance with global standards
- Conducts mock audits and coaches site leadership for successful audit outcomes
- Develops audit and inspection readiness plans
- Collaborates with AbbVie teams for compliance and quality deliverables
- Provides guidance on quality concerns ensuring new product launches meet requirements
Requirements
- Bachelor’s Degree in relevant Life Science or other technical area required
- Graduate degree desired
- 10+ years of experience in Quality Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required
- Experience working in a regulatory agency preferred; direct interaction with regulatory inspectors required
- 6+ years of direct Plant leadership in a pharmaceutical setting preferred
- Experience working with third party external manufacturers preferred
- Comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, devices, etc.)
- Strong analytical problem-solving skills
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k) to eligible employees
- participate in long-term incentive programs