Head of Clinical Quality Assurance

4 weeks ago

Remote, United Kingdom Dechra Pharmaceuticals PLC Full time

Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, sales and marketing of high-quality products exclusively for veterinarians worldwide.

The Head of Clinical Quality Assurance will design, direct and where necessary implement activities related to the quality system in order to maintain and improve the quality processes for field and laboratory studies conducted in support of animal health development programs at Dechra. The Head of Clinical Quality Assurance will maintain a collaborative approach to Quality, ensuring that audit activities are approached as a partnership with the scientific teams at Dechra. Overall, this person will support the PDRA team by helping to build appropriate quality while maintaining focus on rapid project delivery.

The Head of Clinical Quality Assurance will continuously scan the external Animal Health environment to adopt best practice and ensure that the Dechra PDRA quality standards and process remains appropriate for successful registration and maintenance of Dechra’s products. This person will interface with other quality functions across Dechra to ensure harmonization of quality and compliance activities and systems where appropriate.

Main Responsibilities
- The management of GCP/GLP quality systems which include the following:

- Oversight of Standard Operating Procedures
- Updates to current and development of new SOPs
- Management of SOP training programme
- Implementation of systems to assess compliance with SOPs and facilitate improved compliance where necessary
- Management of Work Instruction documentation
- Audit internal records (e.g. employee training records, study files, etc) for compliance with SOPs and applicable regulations, guidelines, and Dechra policies
- Facilitate implementation of non-QA document and data review process to ensure compliance while maintaining efficiency
- Provide team member Quality training as applicable
- Responsible for Sponsor quality assurance oversight of field and laboratory studies (in vivo and in vitro)
- Create study-specific QA plans in coordination with Sponsor Representative and Clinical Operations
- Conduct, or facilitate the conduct of, Quality Assurance (QA) audits of study protocols, reports, raw data, statistical processes and study sites ensuring communication of results with a collaborative approach to ensure corrective and preventative actions are taken as required
- Conduct, or facilitate the conduct of, qualification and regular review (via audit) of facilities for participation in clinical or non-clinical studies.
- Gain internal alignment and push externally, in a positive way that facilities project delivery while maintaining supplier relationships
- Identify regulatory compliance risks and propose proactive mitigation plans to management
- Inspection readiness
- Prepare procedures and training for regulatory authority inspections of Dechra PDRA activities
- Implement mock regulatory authority inspection program
- Attend regulatory authority inspections as appropriate
- Provide GCP and GLP compliance advice and guidance to Team members to achieve continuous quality improvement
- Help to build / encourage a quality by design culture within PD
- Develop a measurement system to track quality and develop a quality learning culture whilst ensuring that the PDRA quality standard remains fit for purpose and focused on project delivery at the right standard.
- Ensure the delivery and recording of Quality training for PDRA staff as appropriate
- Minimum 10 years of experience in compliance activities (GCP/GLP) related to veterinary product development.
- Demonstrated understanding of protocols, data collection methodologies, GCP guidelines, GLP regulations, and report writing.
- Collaborative in a team environment, shares knowledge, influences best practices, and coordinates workflow
- A track record of bringing forward and delivering process improvements designed to drive quality and efficient operations.
- A clear understanding of how to achieve scientific goals whilst maintaining compliance.
- Ability to communicate effectively with excellent written and verbal communications skills.
- Exemplary relationship building skills and the ability to influence.
- Diverse problem-solving skills and strong ability to think “outside-the-box”.
- Self-starter, independent, proactive, and self-motivated.
- Significant experience of Animal Health development programmes
- An ability to bring practical solutions to solve quality issues
- Experience of EU EMA and US FDA-CVM regulatory environments and standards for veterinary product development and registration
- A flexible, hands-on, can-do mentality

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