Clinical Quality Manager

JR United Kingdom; Bath; On-site; GBP 50,000 - 70,000; Full time

Job summary

A leading company in innovative healthcare solutions seeks a Clinical Quality Manager (GCP) to enhance their clinical trials oversight. This role involves developing quality management systems, collaborating with cross-functional teams, and ensuring adherence to GCP regulations. Ideal candidates will have a Bachelor's in Science and extensive QA experience in pharmaceuticals.

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 processes in GxP areas.

Responsibilities

• Develop and maintain an effective clinical quality management system.
• Ensure GCP/ICH-compliant systems and processes are maintained.
• Oversee inspection readiness efforts and conduct audits of investigator sites.

Skills

Strong communication skills

Excellent presentation skills

Training skills

Education

Bachelor's Degree (Science discipline preferred)

Job description

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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.