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Associate Director - Quality and Training

Job Field:
Regulatory and Drug Safety Jobs
QA Jobs
United Kingdom
Contract Type:
Salary Description:
Job Ref:

Provide strategic, tactical and hands-on support to represent, develop, implement and coordinate clinical trial quality for Clintec’s clients. This includes preventing or eliminating GCP infringements as well as coordinating all client related and regulatory body audits for all Clintec facilities and Clintec managed sites. The role will also include an element of training; responsible for planning, ensuring quality deliverables, organizing, leading and supervising the Learning and Development department.

Key Accountabilities - Quality Assurance

Utilising prior QA and Training experiences to provide leadership to QA, Compliance and Training functions within Clintec
Promote a pragmatic, proactive and supportive culture which maintains an appropriate level of regulatory compliance while facilitating the achievement of project deliverables and timelines
Pro-actively contribute to global management team discussion by providing quality/compliance management and consultancy on international projects
Provide input into the development of all Clintec Quality documents regionally and globally, to be the approved signatory
Identify and evaluate potential clinical research misconduct, document and refer on cases of potential causes, assist in determination of root cause and provide assistance in writing failure investigations
Identify process gaps and/or quality deficiencies in Clintec global activities, proposing opportunities for improvement and raising awareness
Oversee the Quality Management System and provide input and training review to all departments in Clintec to ensure compliance with GCP and country specific regulatory requirements
Design and implement audit and assess methods to measure compliance, perform internal and external audits of clinical activities ensuring compliance to regulatory standard guidelines, and company policies/procedures
Ensure that audits are performed as defined in the internal Audit Plan and that corrective and preventative actions (CAPA) are followed up in a timely manner
Drive the overall CAPA Management Process
Design and maintain database of observations for quality analysis, assessment and compliance risk
Provide support for Business Development during the generation of cost proposals for QA services
Provide compliance support prior, during, and after regulatory authority inspections

Key Accountabilities – Training

Management of all training department staff within the company
Evaluate and manage all global training materials of the company
Evaluate all training provision and coverage. Amend, create and refresh as needed
Facilitate training requests
Identify new training (materials, courses, services, delivery methods, and IT software) based on staff developmental needs within the organization
Ensure all staff & contractor training records are 100% compliant
Manage training budget
Provide training and compliance reports to senior management
Contribute to business development activities as required

Candidate specification

Recognised subject matter expert on quality management and training
8-10+ years relevant industry expertise gained within the pharmaceutical / biotechnology industry, ideally in a Clinical Research function
The ability to create a quality culture, and a passion for process improvement to contribute and make a difference across the business
Strong communication and organizational skills
Ability to think analytically and systematically
Strong team leadership capability
Experienced and able to build strong and lasting relationships
Effective at collaboration on cross-functional projects

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package

Closing Date:

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