Wayne Metro Area, New Jersey
- Minimum of a Bachelor degree in Life Sciences, Pharmacy or Medicine, or other related discipline required.
- 5+ years working experience in pharmaceutical development and excellent knowledge of the technical development and clinical operations processes and vendor related activities.
- Good knowledge of GCP, GMP, GVP.
- Manages quality programs to improve total quality of company product and processes. Oversees implementation and compliance with ISO and other applicable quality standards. Researches, analyzes and reports quality trends and other data.
- Demonstrated leadership in implementing robust processes and quality systems, and setting global quality standards in a regulated area, including controlled documentation for the pharmaceutical development area.
- Experience in managing third parties vendors and knowledge of quality standards requirements.
- Demonstrated root cause analysis skills
- Manage implementation of quality standards, processes, tools and systems used in managing external service providers (ESP) across GxP areas in GDQ.
- Responsible for QA ESP oversight activities across Global development Quality (GDQ), supporting and managing activities of the ESP GDQ governance board to ensure risks and trends are evaluated to identify potential quality and performance issues in a proactive manner and to facilitate escalation to GDQ management and External development Operations (EDO) organization including follow-up until risks are mitigated and relevant actions closed. Deputizes for the Chair of GDQ External Service Provider governance board.