Do you have previous experience implementing and monitoring all Quality processes?
Are you looking for an opportunity to ensure products are executed in compliance with cGMP (Current Good Manufacturing Practice) and quality release procedures?
Are you located in California, US, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a growing pharmaceuticals organisation specialising in the development of breakthrough therapies. Operating worldwide, they are committed to improving and saving lives.
Our client is seeking an innovative leader to play an active role in the quality and commercial deliverables for the site, overseeing that batches manufactured meet the required quality, safety and efficacy standards.
Discover more about our Head of Product Quality opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Head of Product Quality, you will be measured against the following objectives:
1) Ensuring that Drug Substance and Drug Product batches are executed in compliance with cGMP regulations and quality release procedures.
2) Maintaining all Quality procedures necessary to provide assurance that batches manufactured meet the required quality, safety and efficacy standards.
3) Identifying and implementing business process improvements to drive business performance and Quality innovation.
What you will do:
As the Head of Product Quality, your duties and responsibilities will include:
- Overseeing that batches are only released once such standards and requirements have been confirmed to comply with specifications and Regulations.
- Providing technical expertise on Quality standards and processes to team members.
- Implementing tactical planning within the department for the daily operations and batch release schedule.
- Presenting the batch release approach and status to management, contract customers and Regulatory Agencies as required.
- Identifying and implementing business process improvements to drive business performance and Quality innovation.
- Managing QA resources to ensure batches are released according to quality standards and in support of project/client timelines.
- Participating actively as a core team member for improvement efforts associated with global procedures.
- Coaching, mentoring, leading and managing QA personnel.
- Working with managers in the department to optimise productivity and quality of work.
What you will bring:
These are the skills and experience you will need to succeed as the Head of Product Quality:
- Excellent leadership skills with an understanding of how best to utilise and motivate staff.
- Demonstrated influencing, relationship building, and effective facilitation and change management skills.
- High level of commercial awareness and business acumen.
- Confident decision-maker and problem solver.
- Knowledge of cGMP regulatory compliance standards and experience presenting quality and site strategies to FDA/EMA.
- Minimum of 10 years’ previous experience working in the Quality aspects of the life sciences.
- Bachelor’s, Masters or PhD degree, preferably in Life Sciences, Engineering or similar pursuit.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Relocation package.
Got what it takes?
To apply for the Head of Product Quality, click the ‘Apply’ button below or contact the Executive Research Manager – Kaitlin Francis – 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.