Clinical Quality Associate Director

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities resourcing and Functional Service (FSP) solutions.

This role is a direct-hire to one of our clients a reputable Big Pharma company.
It is a hybrid role with 3 days per week at the office in Luton London required.

About this role

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 working in 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. Youll 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.