Senior Director of Quality Systems, Biologics

Do you have at least 12 years of previous experience in cGMP and Quality?

Are you looking for an opportunity to maximise the efficiency and effectiveness of a Quality Management System?

Are you located in the US, or are you willing to relocate?

Fraser Dove International is partnering exclusively with a leading biotechnology organisation specialising in speciality products. Operating worldwide, they are committed to saving lives.

Our client is seeking an experienced leader to maximise efficiency, effectiveness, and compliance with all GxP regulations through proactive planning, high-quality training programs, and value-added internal and external audit processes.

Discover more about our Senior Director of Quality Systems opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Senior Director of Quality Systems, you will be measured against the following objectives:

1) Leading the development, design, and maintenance of the Quality Management System.

2) Providing an on-going assessment of the QMS effectiveness via Quality Management Review and other processes.

3) Identifying, prioritising, and executing quality improvement efforts to continually improve efficiency, effectiveness and compliance.

What you will do:

As the Senior Director of Quality Systems, your duties and responsibilities will include:

• Developing and maintaining measures for the cost of Quality/cost of poor Quality and provide routine status reports to management.
• Engaging and enabling the development of site objectives, ensuring that Quality Plan initiatives are properly planned and executed.
• Mentor, and coach staff to continually develop and enhance skills.
• Maintaining oversight of analysis and reporting of Quality System performance metrics.
• Identifying compliance gaps and improvement opportunities to inform the Site Quality Plan.
• Leading the Internal Audit program, including but not limited to audit schedules and plans.
• Overseeing the CAPA system and ensuring clear root causes are identified and addressed.
• Having responsibility for site-wide GMP training programs.
• Coordinating activities for regulatory inspections and reviewing/preparing documentation.
• Fostering a culture that values innovation, continuous improvement, and personal accountability.

What you will bring:

These are the skills and experience you will need to succeed as the Senior Director of Quality Systems:

• Excellent leadership skills with an understanding of how best to utilise and deploy staff.
• A self-motivated individual with high energy and attention to detail.
• A critical thinking approach to processes/policies with an enterprise mindset.
• Significant experience working cross-functionally in global, cross-cultural teams.
• An excellent understanding of regulated activities, health authority expectations and GxP.
• 12-15 years of cGMP/Quality experience.
• Bachelor’s degree in Biology, Chemistry, Engineering or related field.

What you will get:

These are the perks and benefits that will complement your generous base salary:

• 25% bonus
• Stock options

Got what it takes?

To apply for the Senior Director of Quality Systems, click the ‘Apply’ button below or contact the Executive Search Consultant – on +44 (0)203 355 7050.

Please Note:

• 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 ten working days from the date of your application, please consider yourself unsuccessful on this occasion.
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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.