Do you have experience designing and executing Quality Assurance inspection and audit strategies and programmes?
Are you an expert in GCP, GPV and GLP regulations?
Have you successfully prepared, defended and hosted regulatory inspections?
Fraser Dove International is partnering with a creative, award-winning US biopharmaceutical organisation seeking a strategic, result orientated individual to join them as they embark on their growth roadmap.
Discover more about our Executive Director, R&D Audit and Inspections opportunity; it’s objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
What you will do:
As the Executive Director, R&D Audit and Inspections, your duties and responsibilities will include:
- Leading inspections and work with the Health Authority first hand. This will include the setup of the audit and inspection strategy, running the audit and inspection programs for both internal and external audits.
- Build a well-executed inspection and audit plan to ensure a smooth transition between inspection rounds with no problems for the R&D Group to cover GCP, GPV and GLP.
- Provides leadership & Management for the Audit organisation, cascading messages and goals from Sr. Management, managing & prioritizing team workload, managing team performance.
- Key contact for inspectors before, during and after sponsor regulatory inspections. Informed of the clinical site and key vendor inspections activities & outcomes and may coordinate/provide input to inspection responses impacting the organization.
- Identifies approves and serves as the process owner/provides oversight of the design and implementation of relevant GXP Audit and Inspection Management processes and procedures, including metrics, thresholds, continuous improvement initiatives.
What you will bring:
These are the skills and experience you will need to succeed as the Executive Director, R&D Audit and Inspections:
- Background in Quality Assurance in the Biotech or Pharmaceutical space.
- Previous success setting up Audit and Inspection strategies and programmes.
- A deep understanding in GCP and ideally but not essential GPV and GLP.
- 10 years + years’ experience in QA Environment.
- Regulatory inspection management experience and demonstrated management of an audit and Inspection team.
What you will get:
In addition to an annual salary of $250,000 – $260,000, the successful candidate will receive the following perks and benefits:
- Company pension.
- Generous holiday allowance.
- Bonus scheme.
Got what it takes?
- To apply for the Executive Director, R&D Quality Audit And Inspection, click the ‘Apply’ button below or contact the Executive Search Consultant on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.
If you’re exploring executive opportunities in the life sciences, get in touch with our executive search consultants, upload your CV or apply for our life science executive jobs.