We have partnered with an Oncology Biotech company in the San Francisco Bay Area in search of their next Associate Director, Document Management System! The ideal candidate will have excellent leadership and mentoring skills, be energetic, and posses regulatory inspection knowledge for both US and EU.
RESPONSIBILITIES
- Work with stakeholders across the board
- Look through existing SOPs and identify any gaps, flagging over any roadblocks
- Develop and maintain a document management system
- Ensure GxP controlled documents adhere to quality standards
- Support document structure allowing a seamless transition from clinical to commercial, new product introductions and tech transfers across entire network
- Provide technical expertise in the areas of responsibility
REQUIREMENTS
- Needs to have prior Pharmaceutical or Biotech experience
- 3+ years of people management experience, either directly or indirectly leading a team
- Deep knowledge and understanding of drug development process and the Global Regulatory Requirements and regulations related to GXP
- Excellent writing skills and editing, formatting and organization skills