Clinical Quality Associate Director

TFS HealthScience; City Of London; Hybrid; GBP 100,000 - 125,000; Full time

Job summary

A leading Global Contract Research Organization is seeking a Clinical Quality Associate Director to oversee quality in clinical trials. This hybrid role requires 3 days in the office in Luton, with responsibilities including ensuring compliance with GCP and internal procedures and providing support in audits. Ideal candidates will have at least five years of experience in quality assurance within the CRO/pharma sector, particularly in Oncology.

Benefits

Competitive compensation package

Comprehensive benefits

Professional growth opportunities

Qualifications

• At least five (5) years’ experience in clinical trials, including quality assurance.
• Deep understanding of GCP/GxP regulations to interpret audit findings.
• Experience working in the CRO/pharma industry.

Responsibilities

• Act as the first point of contact on quality and compliance matters.
• Develop and manage local country quality plans.
• Ensure adherence to GCP and internal procedures.
• Oversee training compliance and provide training.
• Support issue resolution, investigations, and CAPA management.
• Analyze and interpret quality metrics and track trends.

Skills

GCP/GxP regulations knowledge

Quality assurance experience

Oncology experience

Interpersonal and communication skills

Planning and organization skills

Problem-solving abilities

Fluent in English

Education

University/college degree in a relevant area

Job description

About this role

This role is a direct-hire to one of our clients, a reputableBig Pharma company. It is a hybrid role, with 3 days per week at the office in Luton, Londonrequired.

The Clinical Quality Associate Director is responsible for the quality oversight of the GCP activities related to clinical trials. The Clinical Quality Associate Director performs day-to-day clinical quality operations and compliance activities to support the success of the clinical trial projects. The primary responsibility is to ensure that clinical processes are conducted in accordance with the applicable regulatory requirements, ICH Guidelines (e.g. ICH E6 GCP), Standard Operating Procedures and country-specific requirements, along with current industry standards and practices.

This person has experience in clinical research and quality assurance and is able to provide support and advice throughout this area.

Key Responsibilities

• Act as first point of contact on quality and compliance matters, supporting oncology country teams in delivering high-quality clinical trials.
• Develop and manage local country quality plans and annual quality control plans.
• Ensure adherence to GCP and internal procedures; maintain country-specific guidelines.
• Oversee training compliance, provide onboarding and ad hoc training, and share process updates impacting compliance.
• Support issue resolution, investigations, and CAPA management; promote best practice sharing.
• Foster a strong quality culture by developing and implementing compliance improvement initiatives.
• Provide consultation and support during audits, inspections, and risk reviews; may serve as audit coordinator or SME.
• Analyze and interpret quality metrics, track trends, and contribute to proactive risk and issue management.
• Participate in leadership meetings, deliver quality reviews, and manage country-level risk registers.
• Collaborate with quality networks and stakeholders to resolve issues and align on practices.
• Promote continuous improvement, knowledge sharing, and learning from audits and inspections.

Qualifications

• University/college degree in a relevant are
• Experience workingin the CRO and/pharma industry, including knowledge of GCP/GxP regulations
• Experience within Oncology
• Deep understanding of GCP/GxP regulations and standards to facilitate the interpretation and impact of findings of internal and external audits.
• At least five (5) years’ experience in clinical trials, including quality assurance and quality operation experience.
• Excellent interpersonal and communication skills and ability to work with a team.
• Good planning, organisation and problem-solving abilities
• Fluent in English, both written and verbal

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients

A Bit More About Us

Our journey began over 29 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.

Together we make a difference.