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- Tasks: Lead clinical quality management and ensure compliance in global clinical trials.
- Company: Join a century-old family-owned company revolutionising healthcare with innovative hormonal treatments.
- Benefits: Enjoy a dynamic work environment with opportunities for growth and collaboration across cultures.
- Why this job: Be part of a pioneering team making a real impact on patients' lives worldwide.
- Qualifications: Bachelor's degree and 5+ years in Clinical Quality oversight, preferably in pharmaceuticals.
- Other info: Contact Anita for a confidential chat about this exciting opportunity.
The predicted salary is between 43200 - 72000 £ per year.
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.
- Strong project management skills.
- 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 +44 (20) 3769 7178 for a confidential discussion.
Clinical Quality Manager employer: HRM - Delivering Leadership Talent
Contact Detail:
HRM - Delivering Leadership Talent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Quality Manager
✨Tip Number 1
Familiarise yourself with Good Clinical Practice (GCP) guidelines and the specific regulations that govern clinical trials. This knowledge will not only help you in interviews but also demonstrate your commitment to maintaining high-quality standards in clinical operations.
✨Tip Number 2
Network with professionals in the clinical quality management field, especially those who have experience in the pharmaceutical industry. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in clinical quality.
✨Tip Number 3
Prepare to discuss your experience with audits and regulatory inspections in detail. Be ready to share specific examples of how you've ensured compliance and improved processes in previous roles, as this will highlight your expertise and suitability for the position.
✨Tip Number 4
Showcase your project management skills by discussing any relevant projects you've led or contributed to. Highlight your ability to work collaboratively with cross-functional teams, as this is crucial for the Clinical Quality Manager role at our company.
We think you need these skills to ace Clinical Quality Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in clinical quality oversight, particularly in the pharmaceutical industry. Emphasise your 5+ years of experience and any specific projects that demonstrate your skills in GCP compliance and audit processes.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for improving lives through healthcare solutions. Mention your understanding of the company's legacy and how your background aligns with their commitment to innovation and quality in clinical trials.
Highlight Key Skills: In your application, clearly outline your project management skills and experience working with cross-functional teams. Provide examples of how you've successfully managed quality records and conducted audits to ensure compliance with regulations.
Proofread Your Application: Before submitting, carefully proofread your application materials for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a Clinical Quality Manager role.
How to prepare for a job interview at HRM - Delivering Leadership Talent
✨Know Your GCP Inside Out
As a Clinical Quality Manager, you'll need to demonstrate a solid understanding of Good Clinical Practice (GCP) and ICH guidelines. Brush up on these regulations and be prepared to discuss how you've applied them in your previous roles.
✨Showcase Your Audit Experience
Highlight your experience with audits and quality oversight processes. Be ready to share specific examples of audits you've conducted or participated in, and how you ensured compliance with protocols and regulations.
✨Emphasise Collaboration Skills
This role requires working closely with cross-functional teams. Prepare to discuss instances where you've successfully collaborated with other departments, such as Clinical Operations or Regulatory Affairs, to achieve common goals.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills and decision-making abilities. Think of situations where you've had to manage quality records or resolve deviations, and be ready to explain your thought process.
