Hobson Prior is seeking a QA Manager/Senior QA Manager for a permanent role fully remote. The successful candidate will play a crucial role in establishing and maintaining a Quality Management System (QMS) across all functions. This role will involve a variety of tasks, including developing standard operating procedures (SOPs), ensuring compliance with regulations, and managing audits.

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

Key Responsibilities

• Set up and maintain a QMS across all functions, including change control and annual reviews.
• Develop SOPs, policies, and procedures in line with international standards.
• Host QMS periodic reviews to monitor performance, effectiveness, and evaluate trends.
• Manage the implementation of a validated QMS software system.
• Collaborate with cross-functional management to drive process and system improvements.
• Ensure all operational processes comply with regulations.
• Develop phase-appropriate SOPs, policies, and procedures.
• Collaborate with the QP to support the review of manufacturing and quality control records.
• Contribute to the preparation, review, and upkeep of product specification files.
• Provide quality support on various GMP studies.
• Manage the audit program including execution of internal and external audits.
• Monitor and support risk management activities.
• Maintain knowledge of existing and emerging industry-related regulations, standards, or guidance documents.
• Oversee, manage and deliver the training programs.
• Offer specialist advice to all team members to enable operational efficiency.

Requirements

• Strong experience in GCP QA, helping implement QMS.
• Good understanding of GMP/GLP.
• Experience managing vendors and clinical trial.

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click Apply and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select Contact me at the top of this page.

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

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