Director / Senior Director GCP Quality Assurance
ProClinical is partnering with a biopharmaceutical company focused on developing cancer treatments. This organisation is currently recruiting for an experienced Senior Director/Director of GCP Quality Assurance to join either of their offices in California or the UK. This is an exciting time to join this company who operate across the United States, Europe and other international markets and have an extensive pipeline of products under development.
As, Sr. Director/Director of GCP QA, you will establish the vision and implement the associated strategy for the clinical Quality Assurance function. This includes developing, executing, and maintaining of risk-based audit strategies focused on internal and Good Clinical Practice (GCP) audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, Clovis Oncology procedures, and clinical trial protocols. Furthermore, the Sr. Director/Director of GCP QA will deploy comprehensive GCP inspection readiness plans which require overall management of a large cross-functional team.
- Establishing the vision and implementing the associated strategy for the clinical Quality Assurance function.
- Managing and/or participating in complex audits, including but not limited to, internal process, external vendors and clinical investigator sites; determining compliance status and identifying compliance risks.
- Instituting comprehensive GCP inspection readiness plans for regulatory authority inspections and conducting GCP inspections.
- Directing the development of adequate and appropriate responses and resolutions to identified observations.
- Driving timely completion of the agreed corrective and preventive actions.
- Identifying, communicating, and escalating GCP corporate risk and serious non-compliance situations and following to resolution, acting with an appropriate sense of urgency.
- Establishing effective means for communicating audit and inspection outcomes, developing metrics, measuring trends, and driving improvements thus identified.
- Monitoring and reinforcing the timely completion of corrective and preventive actions that are defined to address GCP issues.
- Attending clinical sub-team and ad hoc meetings internally and externally, at investigator meetings as needed, to present quality system expectations and GCP training.
- Ensuring policies and/or procedures within clinical research, (such as Clinical Development, Translational Medicine, Molecular Diagnostics and other departments) are building quality within clinical research programs and activities, particularly focusing on a risk-based approach.
- Performing detailed reviews of policies, procedures, work instructions, clinical trial protocols, regulatory submissions, internal deviations, CAPAs, and other essential documents prior to their Quality Assurance acceptance or approval.
- Representing GCP Quality Assurance on compliance-related projects and initiatives; leading such projects and initiatives, particularly those related to application of new and revised industry standards, guidelines and regulations within all affiliated areas of GCP.
- Participating in the development and management of the departmental budget.
Skills and Requirements:
- A Bachelor or a Masters' degree in a scientific or life sciences discipline, with a healthcare background preferred.
- At least 15 years of relevant and increasingly responsible experience in the Biotech/ Pharmaceutical Industry, specifically within GCP, clinical monitoring or equivalent and with at least 10 years in quality or compliance.
- Extensive experience in GCP auditing and managing regulatory authority inspections.
- A minimum of 7 years direct management experience.
- An in-depth knowledge of the drug development process (early through late stages), trial design, data and trial management procedures.
- A demonstrable ability to define and implement procedures which ensure compliance to GCP and regulatory standards.
- Extensive experience in and knowledge of internal and external GCP auditing and quality systems operations.
- Wide-ranging experience leading regulatory authority inspections of clinical research activities, particularly in the US and EU, but also in Rest of World regions.
- A current and in-depth knowledge and application of international requirements of Good Clinical Practice (GCP), ICH GCP Guidelines, regulations and compliance initiatives globally applicable to the conduct of clinical trials.
- Strong knowledge of health authority submission activities, specifically in relation to GCP, for regulatory filings in USA, EU and Rest of World regions.
- Capable of working in a team, analysing, and working with attention to detail, process and prioritise sensitive complex information, and solving problems.
- 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 in 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 call Josh Godden on + 442038540101 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.
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