Clinical Quality Manager

JR United Kingdom; Bolton; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in healthcare innovation seeks a Clinical Quality Manager to oversee the quality of clinical trials on a global scale. The position requires a strong background in Clinical QA and experience with regulatory inspections, ensuring compliance with standards while developing robust quality systems across investigational sites. Candidates should have excellent communication and collaboration skills, along with a passion for improving patient outcomes.

Qualifications

• 5+ years' experience in a Clinical Quality oversight role.
• Clinical QA experience in the pharmaceutical industry essential.
• Experience in audits and/or quality oversight in GxP areas.

Responsibilities

• Develop and maintain an effective clinical quality management system.
• Collaborate with cross-functional teams to support clinical trial programs.
• Ensure GCP/ICH-compliant systems and processes are maintained.

Skills

Communication

Team Collaboration

Presentation Skills

Education

Bachelor's Degree (Science discipline preferred)

Job description

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Clinical Quality Manager, bolton, greater manchester

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Client:

HRM Search Partners

Location:

bolton, greater manchester, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

5

Posted:

26.06.2025

Expiry Date:

10.08.2025

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Job Description:

For over a century and five generations, this family-owned company has been dedicated to improving lives through innovative healthcare solutions, particularly in hormonal treatments for women's and men's health.

Now seeking a Clinical Quality Manager (GCP), the company continues to build on its legacy of pioneering breakthroughs. Over the past 20 years, they have expanded into a global operation with a direct presence in 22 countries and a multicultural team of 1,500 employees worldwide - having doubled in size in recent years. Generating $500 million in annual revenues, their remarkable growth is driven by a commitment to innovation, diversity, and a deep understanding of what truly matters to patients and their families.

The Position

• Develop and maintain an effective clinical quality management system to oversee investigational sites and vendors.
• Collaborate with cross-functional teams (Clinical Operations, Project Management Office, Medical, Regulatory, Pharmacovigilance, etc.) to support clinical trial programs for both new products and new indications of marketed products.
• Ensure GCP/ICH-compliant systems and processes are established and maintained to uphold the quality of clinical trials conducted globally and locally, as needed.
• Contribute to the development, review, and continuous improvement of clinical processes and Standard Operating Procedures (SOPs).
• Monitor adherence to applicable SOPs, guidelines, and regulatory requirements across clinical activities.
• Oversee inspection readiness efforts, including planning and coordination of inspection-related activities.
• Assess and qualify Clinical Research Organizations (CROs) and other vendors involved in clinical operations.
• Develop audit plans, and conduct investigator site audits to ensure compliance with protocols, Good Clinical Practice (GCP), and applicable regulations.
• Oversee CRO and investigator monitoring activities to ensure alignment with protocols, GCP, regulatory requirements, and internal policies.
• Manage quality records, including change controls, investigations, deviations, and Corrective and Preventive Actions (CAPAs), ensuring timely resolution and closure.

The Person

• Bachelor's Degree (Science discipline preferred).
• 5+ years' experience in a Clinical Quality oversight role.
• Clinical QA experience in the pharmaceutical industry essential.
• Experience in audits and/or quality oversight processes in GxP areas.
• Experience carrying out regulatory inspections.
• You work independently as well as collaboratively with cross functional teams.
• Strong communication skills both written and verbal.
• Excellent presentation and training skills.

To learn more about this role apply online or contact Anita Osibuamhe on [phone] for a confidential discussion.