Do you have experience in ensuring that Quality Assurance activities are compliant with regulations?
Are you looking for an opportunity to push Quality up the agenda in a growing organisation?
Are you based in San Francisco, USA, or are you willing to relocate?
Fraser Dove International is partnering exclusively with an innovative organisation specialising in developing drugs to treat rare diseases. Operating worldwide, they are committed to making a difference in patients’ lives.
Our client is seeking a proactive leader to take ownership over the QA (Quality Assurance) function, ensuring that business goals are met, and activities are compliant with industry regulations.
Discover more about our Quality Assurance Executive Director opportunity; it’s objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Quality Assurance Executive Director, you will be measured against the following objectives:
1) Working closely with the Global Quality Leadership team to ensure regulatory QA compliance at US sites.
2) Implementing a culture change and pushing Quality up the agenda.
3) Acting as the host and expert during Health Authority Inspections.
What you will do:
As the Quality Assurance Executive Director, your duties and responsibilities will include:
- Overseeing that QA activities are compliant with US regulations and internal policies.
- Ensuring that business goals are met, and the level of Quality remains high.
- Developing QA strategy for Pharmacovigilance in compliance with regulations.
- Ensuring the QA system is effective and adheres to industry best practices.
- Developing and maintaining quality standards and processes across the organisation.
- Leading Health Authority Inspections and implementing changes accordingly.
- Producing comprehensive reports on QA and providing input to the Global Quality Management Review meetings.
- Designing and building the function while pushing Quality up the agenda.
- Recording, supporting and reporting on all QA activity.
What you will bring:
These are the skills and experience you will need to succeed as the Quality Assurance Executive Director:
- Track record of delivering and managing QA function.
- First-rate stakeholder engagement and management skills.
- High level of commercial awareness and business acumen.
- Determination to overcome setbacks and drive business performance.
- Highly experienced in communicating with regulatory bodies.
- Minimum of 15 years’ experience in Biopharma industry and at least 10 years’ experience in QA and Quality Management.
- Master’s degree in a Life Science related field.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- • Short-term bonus.
• Long-term incentive.
• Generous holiday allowance.
• Life insurance.
• Car/travel allowance.
Got what it takes?
To apply for the Quality Assurance Executive Director, click the ‘Apply’ button below or contact the Head of Research – Peter Vedde – 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.