QA Manager, GMP

Proclinical is seeking a GMP QA Manager to oversee quality assurance activities related to subcontracted manufacturing operations. This position ensures compliance with regulatory standards and maintain high product quality and safety. The successful candidate will collaborate with internal teams and external contractors to manage quality events and fulfil responsibilities effectively.

Responsibilities:

• Maintain and improve the Quality Management System (QMS) in line with regulatory standards.
• Document and enhance QA processes and procedures.
• Conduct audits and participate in regulatory inspections.
• Ensure product compliance with regulations and implement new requirements.
• Prepare and review quality-related documentation and reports.
• Conduct risk assessments and manage quality issues.
• Oversee the CAPA process and manage change control.
• Provide training and development in QA processes.
• Collaborate with cross-functional teams to ensure product quality.
• Lead initiatives for process improvements and quality enhancement.

Key Skills and Requirements:

• Degree in pharmacy or related field preferred.
• Experience with GMP in manufacturing, understanding of CMOs.
• Strong knowledge of Good Manufacturing Practices.
• Experience in quality management systems and regulatory inspections.
• Excellent communication skills; proficiency in English required, other languages a plus.
• Ability to manage multiple projects in a fast-paced environment.
• Certification in quality assurance is a plus.
• Willingness to travel to CMO partners.
• Agile thinker, problem solver, and team player with a growth mindset.

If you are having difficulty in applying or if you have any questions, please contact Ingrid Aymes at i.aymes@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.