Product Quality Manager

Proclinical is seeking a dedicated Quality Assurance Specialist to drive operational quality assurance activities for commercial biological drug products. This role will also contribute to the development of GMP quality infrastructure in collaboration with internal teams.

Responsibilities:

• Collaborate with vendors, Tech Ops teams and other Product Quality managers to manage deviation investigations, change controls and product complaints.
• Analyse batch record documentation and support the release of commercial products.
• Assess Product Quality Review (PQR) reports from vendors.
• Support the compilation of submission dossiers and related queries from Health Authorities.
• Monitor and trend vendor performance and maintain key performance indicators for key operational QA activities.
• Support the further development of quality processes and systems.
• Identify the need for global or local processes to ensure compliance with regulatory requirements.
• Review quality agreements with external parties.
• Support the Global External Audit Program through the execution of qualification audits and routine GMP audits.
• Provide expert advice and support on operational and general QA activities for projects part of the commercial portfolio.

Key Skills and Requirements:

• In-depth knowledge of FDA, PMDA, NMPA, EU regulations, and ICH Guidelines.
• Experience in Product Quality Complaint Management.
• Ability to work independently and make decisions based on experience.
• Strong leadership and communication skills.
• Versatility and flexibility in managing projects and making decisions related to product quality issues.
• Strong technical mastery, analytical and investigation skills.
• Quality Auditing experience is an advantage.
• Ability to operate in a dynamic environment of a fast-growing biotech company with challenging timelines.

Interested or know someone who might be? Reach out to ­­­­Josh Godden using the following:

✉️ j.godden@proclinical.com

📞 0203 854 0101 (5324)

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.