QA Operations Team Manager

QA Operations Team Manager

[Employer hidden — view at passion-project.co.uk] is seeking a QA Operations Team Manager to oversee and support the Quality Management System (QMS) for our client’s UK operations, ensuring compliance with EU, UK, and US GMP regulations. You will lead a team, drive continuous improvement, and ensure inspection readiness while collaborating with teams in Ireland and the USA as needed.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Lead and manage the QA Operations and Document Control team to ensure smooth daily operations.
• Act as the main point of contact for operational quality issues.
• Oversee internal audits and ensure timely follow-up on findings.
• Support investigations into quality issues and implement corrective actions.
• Provide training and guidance on quality systems across UK, USA, and Ireland sites.
• Ensure timely review of batch records to facilitate product release.
• Collaborate with operational teams to address and resolve potential quality issues.
• Manage risks, deviations, change controls, and corrective actions to meet deadlines.
• Prepare for and support regulatory inspections and audits.
• Develop and deliver compliance training to operational teams.
• Foster a culture of quality and compliance within the organization.
• Oversee team performance, including hiring, mentoring, and development.

Key Skills and Requirements:

• Strong leadership and team management skills.
• Strategic thinker with experience in risk management.
• Familiarity with sterile/aseptic GMP manufacturing environments.
• Proficient in Microsoft Office and electronic QMS systems.
• Excellent organizational and time management skills.
• Strong attention to detail and ability to work independently or as part of a team.
• Knowledge of GMP regulations and QMS activities.
• Experience with regulatory inspections and audits.
• Science-based degree (e.g., Chemistry, Biology, Pharmacy) preferred.
• Strong communication and interpersonal skills.

For more information, please contact Frankie Cunningham.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.