Do you have experience in managing people in a Quality Assurance role and strong knowledge in cGMP requirements?
Are you looking for an opportunity to develop and implement the Quality strategy at a mid-scale facility?
Are you located in New Hampshire, US, or are you willing to relocate?
Fraser Dove International is working exclusively with an established biotechnology organisation specialising in pioneering cell therapies and new medicines. Operating worldwide, they are dedicated to becoming the world’s leading pharma healthcare organisation.
Our client is seeking a visionary leader to oversee all aspects of QA for the manufacturing asset and manage the QA team.
Discover more about our Head of Quality Assurance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Head of Quality Assurance, you will be measured against the following objectives:
1) Overseeing all aspects of quality assurance for the manufacturing asset, ensuring that the quality systems meet global standards and regulatory requirements.
2) Ensuring that project and delivery timelines meet expectations for product quality and GMP (Good Manufacturing Practices) compliance.
3) Building strong relationships with internal and external stakeholders.
What you will do:
As the Head of Quality Assurance, your duties and responsibilities will include:
- Developing and implementing the overall quality strategy for the mid-scale facility.
- Partnering with the Site Director and Site Leadership Team to ensure alignment with Manufacturing and support functions in executing the strategy.
- Managing the asset QA budget and resources to maximise efficiency and maintain quality/compliance at high levels.
- Developing, directing, and maintaining quality systems in support of manufacturing.
- Overseeing all aspects of QA operations within the facility, including batch record review, deviation investigations, change controls and Quality agreements.
- Releasing clinical and commercial batches.
- Ensuring QA support for internal and external project and team meetings.
- Owning decision-making for all asset Quality issues and informing Site QA Head of critical issues in a timely manner.
- Building and maintaining expertise in the asset QA team, ensuring the development of staff.
What you will bring:
These are the skills and experience you will need to succeed as the Head of Quality Assurance:
- Ability to collaborate with key stakeholders to build the organisation and deliver the success.
- Ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted.
- Confident decision-maker with the ability to think strategically.
- Self-motivated and accountable individual prepared to fix any issues that arise.
- Strong knowledge in the application of cGMP requirements to biologics manufacturing processes.
- Prior experience in biologics API or drug product QA in a GMP environment.
- Bachelor’s degree in life sciences or engineering.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Full relocation package
- Sign-on bonus
Got what it takes?
To apply for the Head of Quality Assurance, click the ‘Apply’ button below or contact the Executive Search Consultant – Jason Cachia – 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.