Wayne Metro Area, New Jersey
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.
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.
Single point of contact for reviewing related standards in QA agreement with ESP to coordinate and share information across groups and to ensure processes are implemented, metrics are reported and followed-up on to achieve a holistic landscape of ESP across GDQ.
Facilitates effective collaboration with the GDQ line functions responsible for day to day ESP operations.
Assures the quality and compliance to regulatory standards of outsourced activities within respective (GxP areas).
- 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.
- 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.
- Thorough technical understanding of specifications setting, collecting, analyzing and monitoring.
- Experience in data analysis and trending using Microsoft based or other tools.
- Demonstrated effective management and establishment of successful international and cross-divisional collaborations.
- Demonstrated root cause analysis skills
- Ability to work in a global team and matrix structure organization, meet timelines and work with minimal supervision
- Excellent communication and interpersonal skills.
- Self-motivated with a high degree of ownership and responsibility for results
Minimum a Bachelor degree in Life Sciences, Pharmacy or Medicine, or other related discipline required.