Senior Director Clinical Quality Assurance
An internationally renowned pharmaceutical company is seeking to recruit a Senior Director Clinical Quality Assurance to their office in the UK. The organisation works across a range of therapeutic sectors, including oncology, neurology, and gastroenterology. This position is an exciting opportunity to work with a global establishment that discovers and develops innovative therapies to help address unmet medical needs.
- Designing, delivering, and executing the global Clinical Quality Assurance (CQA) strategy, including audit and inspection management, issue management, and oversight of the Quality management system.
- Assuming responsibility for the oversight of Good Clinical Practice (GCP) and Pharmacovigilance (PV).
- Assuring the compliance of projects, products, and programs with the company's Standard Operating Procedures (SOPs), Policies, and all applicable worldwide regulations and guidelines (e.g. EU Directives, US FDA, PMDA, ICH, and National regulations).
- Main duties/responsibilities
- Developing and executing QA strategy.
- Completing audit program spanning site, vendor, process, systems, regulatory submissions, and clinical trial documents.
- Conducting wide range and GxP (Good Practices Quality Guidelines and Regulations) complex audits (i.e. directed, for-cause, etc) in accordance with QA risk-based processes.
- Maintaining oversight, guiding subject matter experts in developing solid CAPA, and resolving CAPA from audits in order to prevent repeat or complex resolution to findings.
- Leading and supporting inspection preparation.
- Ensuring that health authority inspections of global clinical facilities and study sites are facilitated.
- Leading the development of responses to inspection observations and overseeing corresponding CAPA.
- Liaising and communicating with regulatory agency/ies for inspection responses and follow-ups.
- Leveraging internal audit and industry intelligence relating to inspections and sharing results with teams in order to improve the effectiveness of the Quality Management System.
- Ensuring management of quality issues is robust and comprehensive.
- Triaging quality issues for significance and assuring the appropriate and timely escalation of quality issues, including potential misconduct, according to the company's established SOPs and regulatory requirements.
- Overseeing validation deliverables for Clinical GxP systems and software to ensure compliance with regulations and guidelines.
- Promoting the spirit of proactive, continuous quality improvement.
- Acting as a strategic and proactive thinker, providing strong input and guidance to situations that arise that require in-depth knowledge of SOPs, GCP, PV regulations, and guidelines, as well as local regulations.
- Developing and delivering awareness sessions on various GCP (Good Clinical Practice) and PV topics internally and externally.
- Driving Interactions with QA colleagues at other company locations to ensure consistency in application of the QA strategy and promoting standardisation of auditing approach within QA.
- Providing training and mentorship to less experienced members of CQA staff.
- Actively engaging in appropriate activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues.
- Exemplifying, driving, and promoting a culturally diverse environment.
- Leading complex, large-scale CQA initiatives with significant business impact with minimal oversight.
Skills and Requirements:
- Bachelor's degree in a scientific discipline; Master's degree preferred.
- Demonstratable relevant clinical pharmaceutical experience (i.e., clinical development or operations, regulatory compliance), including previous Clinical Quality Assurance experience conducting a broad range of audits.
- Successful track record of supervising employees and managing cross-cultural differences.
- 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 Joshua Godden at +44 2038540101 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Bad Homburg vor der Höhe (61348), Germany
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