GCP Quality Governance Operations Lead
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Job Description
GCP Quality Governance Operations Lead managing quality governance forums in pharmaceuticals. Leading initiatives to ensure compliance with GCP regulatory requirements and quality management standards.
Responsibilities:
- Works with the quality governance chairs and coordinators to lead and execute quality governance forums addressing quality concerns and risk adjudication and escalation.
- Plans, drafts, reviews and delivers outputs from quality governance forums including escalations, decisions, annual reports and other documentation as well as coordinate, prioritize and sequence quality governance topics.
- Directs GCP quality governance metrics and assessment of GCP quality governance effectiveness and efficiency. Collects and reports data to support assessment of compliance to process, trends, and common issues with a view towards overall impact and continuous improvement
- Serves as liaison between GCP quality governance board members and teams providing clear communication and direction on goals and objectives for review completion.
- Initiates and coordinates the periodic review of the GCP QMS Manual and the management of related training
Requirements:
- 5+years of related pharmaceutical and/or quality experience
- A robust understanding of GCP regulatory requirements and the Quality Management System (QMS)
- Excellent verbal and written communication skills; must be able to interact effectively with professionals at all levels and communicate recommendations with diplomacy and tact
- Strong project management skills, with experience managing time sensitive projects
- Bachelor’s Degree or equivalent experience a must
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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