Quality Director

Recruiter
Wentworth Pharmaceutical
Location
Wiltshire
Posted
11 Jan 2018
Closes
17 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
This is an outstanding permanent opportunity with our biopharm client in the Wiltshire area, key duties will include:

- Ensure GMP and quality system compliance of all products and relevant operations with UK, US and international pharmaceutical GMPs and form a close working relationship with the Managing Director, Company Secretary and other Senior Executives and Non Executives.
- Oversee the internal GMP and quality system audit program for all products.
- Design, implement, and administer a management escalation process to ensure appropriate issues are elevated for management awareness and intervention.
- Facilitate the management review process with executive management.
- Ensure the quality and compliance of all required regulatory notifications.
- Communicate with regulatory bodies as necessary and host regulatory inspections, as necessary.
- Monitor the external FDA, MHRA and Japanese regulatory landscape to assure internal systems and controls are in line with current practices and approaches to compliance.