One of the largest CROS in the global market is currently recruiting a QA Director to their Reading team on a home-based capacity. This contract research organisation (CRO) is renowned for their work in technological advances and access to real-world data. This is an exciting opportunity to work on ground-breaking new medicine developments.
- Process Assessments
- Conducting annual Process Robustness Assessment and ongoing risk analysis of Clinical Operations (Clin Ops) systems and processes to recommend process audits for the Global Annual Audit Plan, and support process audit conduct.
- Monitoring progress, with Clin Ops Process Owners, of strategies and action plans to improve existing KCPs.
- Supporting the investigation of current/recurring key issues or findings relating to Clin Ops by reviewing the existing processes, CAPAs and initiatives to identify gaps and make recommendations to the Lead QA and operations.
- CAPA Management
- Facilitating the processing of critical Quality Issues for Clin Ops.
- Maintaining oversight of the status of approved preventive actions to address improvement opportunities.
- Working with Clin Ops Functional Heads and their representatives to ensure efficient and timely processing of audit reports/findings and Quality Issues in their domain.
- Process Improvement Initiatives and New Service offerings
- Monitoring and proactively contribute to improvement initiatives undertaken by Clin Ops and the development of new service offerings.
- Providing consultancy and input into incremental process improvements, such as advising on SOP content.
- Customers and Regulators
- Maintaining an up-to-date knowledge of emerging/changing regulations and changing expectations of regulatory inspectors and customers. Assess the risks and feedback recommendations to Clin Ops.
- Hosting or support Regulatory inspections and customer audits as the SME for Clin Ops.
- Insights and Reporting
- Reviewing audit findings and Quality Issue/ Nonconformance events as they relate to Clin Ops on an ongoing basis. Conduct periodic trend analyses.
- QA insights to feedback to Clin Ops management. Facilitate periodic management quality reviews and capture and track agreed actions.
- Support QA colleagues
- Supporting QA colleagues in the oversight of the practices of other Business Areas conducting work allied to Clin Ops.
- Contribution to Functional QA Strategy
- Contributing ideas for improvements in the services of the Functional Strategy Team, and to the development of new, more impactful, efficient or effective ways of working.
- Line Management
- Managing a team of one other Functional QA Leads working to support Clin Ops services.
Skills and Requirements:
- Circa 8 years' experience working in Clinical Operations and/or Clinical Quality Assurance
- Line Management Experience
- Experience in hosting customer audits and regulatory inspections
- Experience of interacting with and influencing Executive Management
- Experience working in a CRO is desirable, but not a pre-requisite
- Extensive knowledge of Clinical Operations regulations and their interpretation
- Strong knowledge of pharmaceutical research and development processes and regulatory environments.
- Detailed working knowledge of quality assurance processes and procedures.
- Excellent problem solving, risk analysis and negotiation skills.
- Possess experience in conducting audits, writing audit reports and analysing audits.
- Demonstrated ability to lead and manage multiple responsibilities.
- Ability to identify functional constraints and identify solutions.
- Ability to coordinate timelines with internal customers and external vendors.
- Demonstrated experience of maintaining up to date knowledge of regulatory requirements, including changes in requirements and expectations.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia at 0203 854 3317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.