Do you have previous experience working in GMP Quality Assurance Functions within commercial Aseptic/Sterile manufacturing?

Are you looking for an opportunity to develop a strategy for ensuring compliance with medical device and drug regulations?

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

Fraser Dove International is working exclusively with an established biologics 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 proactive leader to oversee all aspects of QA and compliance with applicable regulations for Media (Liquid and Powder) and LAL products.

Discover more about our Head of QA Operations opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.

Your objectives:

As the Head of QA Operations, you will be measured against the following objectives:

1) Bringing Quality up the agenda.
2) Developing a closer working relationship with Operations.
3) Improving the Quality Operations function.

What you will do:

As the Head of QA Operations, your duties and responsibilities will include:

  • Directing staff of QA Media and LAL Operations specialists and overseeing batch release.
  • Developing and planning strategy and departmental goals, establishing timelines and monitoring progress.
  • Managing QA on the floor team to observe aseptic processing and media fills and ensure processing requirements are met.
  • Assessing facility and quality systems’ compliance with internal requirements and appropriate regulations.
  • Participating in the development of actions plans to correct deficiencies and improve quality processes.
  • Providing direction for complex deviations and compliant investigations.
  • Managing media deviations, CAPAs and Compliant handling and ensuring that quality-related deviations and complaints are investigated and resolved.
  • Leading and supporting regulatory or client audits as the Aseptic Media subject matter expert.
  • Developing and improving cGMP documents including SOPs and specifications.

What you will bring:

These are the skills and experience you will need to succeed as the Head of QA Operations:

  • An extensive leadership skillset of managing both large and small teams.
  • Confident decision-maker and the ability to think strategically.
  • Strong cross-functional stakeholder engagement skills with the ability to bring Quality up the agenda.
  • Track record of meeting and exceeding targets in a fast-paced environment.
  • Previous experience turning around a facility that has come under an FDA warning letter.
  • Substantial management experience in a QA supervisory or management role.
  • 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:

  • 20% Bonus
  • Bonus Accelerator
  • Medical insurance
  • Relocation package
Got what it takes?

To apply for the Head of QA Operations, click the ‘Apply’ button below or contact the Executive Search Consultant – Jason Cachia – 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.
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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.

If you’re exploring executive opportunities in the life sciences, get in touch with our executive search consultants, upload your CV or apply for our life science executive jobs.