The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality culture.
- Responsible for inspection readiness and compliance programs for external operations. Works cross-functionally and cross-company to ensure sites achieve and maintain a state of inspection readiness.
- Drive identification and resolution of issues, gaps and risks through collaboration with operational areas, assessments, audits, and evaluation of trends.
- Support and oversee inspection execution including responses and closure of CAPAs.
- Collaboration and Integration: Serve as an integrator across multiple functions, fostering collaboration and knowledge sharing. Develop trusted partnerships with external sites.
- Drive optimization, continuous improvement, and operational excellence to enhance processes.
- Report inspection readiness status including risks to leadership and governance forums
- Knowledge of regulatory requirements and inspection expectations globally
- Experience in multiple modalities preferred
- Strong technical knowledge including but not limited to: inspection management and risk management
- Continuous improvement experience such as six sigma or lean
- Proven ability to lead improvement projects and project teams and organize various teams and forums
- Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
- Proven ability to identify and analyze performance indicators.
- Bachelor's degree in a scientific discipline, or allied health field or equivalent degree
- 8+ years of relevant experience
Travel requirement: up to 10-20% including international travel possible
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select On-Site : work five days per week on-site with ad hoc flexibility.