Are you a senior leader with robust experience in Quality Assurance and GMP manufacturing?
Are you looking for an opportunity to implement continuous improvement strategies to develop the Quality strategy?
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 strong leader to provide strategic leadership and management for the Cell and Gene Therapy Quality organisation. They will be tasked with ensuring that teamwork, high morale and innovation are fundamental components of the team.
Discover more about our Associate Director of Quality Assurance opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Associate Director of Quality Assurance, you will be measured against the following objectives:
1) Overseeing the entire Cell and Gene Therapy function for QA.
2) Providing strategic leadership and growth strategy implementation.
3) Serving as a subject matter expert in Cell and Gene Therapy regulatory compliance.
What you will do:
As the Associate Director of Quality Assurance, your duties and responsibilities will include:
- Developing and executing the Quality strategy while ensuring that it aligns with the organisation’s business strategy.
- Implementing continuous improvement initiatives to drive Quality programmes and ensure maximum productivity.
- Ensuring systems meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
- Developing and monitoring Quality programs, policies and procedures to ensure compliance with GMP standards, corporate qualities, FDA, EMA and other regulatory regulations.
- Acting as a subject matter expert for GMP QA during audits and regulatory inspections.
- Evaluating all current Quality systems and processes and recommend appropriate improvements.
- Creating active training and development plans for Quality staff to drive competence and professionalism.
- Establishing and maintaining a positive working relationship with customers, the FDA and other regulatory bodies.
- Serving as the site Cell and Gene Therapy Quality expert and providing support when needed.
What you will bring:
These are the skills and experience you will need to succeed as the Associate Director of Quality Assurance:
- Excellent communication skills and ability to collaborate with others.
- Confident decision-maker and ability to make practical, compliant decisions.
- Ability to manage projects and prioritise appropriately.
- Excellent leadership skills with an understanding of how best to utilise and deploy staff.
- Advanced understanding of GMP, FDA and EMA regulatory requirements.
- Substantial relevant experience in GMP manufacturing and Quality Management of products regulated by FDA.
- Bachelor’s degree in a Life Sciences, Engineering or Quality Management discipline.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- 20% bonus.
- Health care.
- Relocation assistance.
- Clear growth path.
Got what it takes?
To apply for the Associate Director 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.