Director of QA, GCP

10 Jan 2019
24 Jan 2019
Quality, QA / QC
Contract Type
ProClincial is working with a global healthcare company that is seeking a Director of QA, GCP, to be based in Nyon Switzerland on a permanent basis. The Director of QA, GCP will provide compliance leadership and work with quality management, external auditors, in conjunction with clinical department to ensure GCP and GLP-clinical compliance across all company projects. The position will be responsible for implementing clinical compliance processes including SOPs and plans to include external GCP audits of clinical services providers, CROs, suppliers, and investigator sites, as well as internal audit of clinical processes and procedures including selection of provider which could conduct these services as needed. In addition, the job holder will serve as the GCP compliance partner to CROs providing the expertise in request for proposals, clinical quality agreements, oversight, CAPAs etc. Inspection readiness and leading inspections at Sponsor and sites is a given.

Job Responsibilities:

* Formulate GCP compliance strategy and provide advice for all programs within FKSBS in collaboration with key stakeholders
* Develop, implement and maintain Quality Management Systems and SOPs for Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) related to clinical activities in compliance with the applicable regulations.
* Partner with Clinical Development, Clinical Operations, Nonclinical and Regulatory Affairs stakeholders regarding compliance issues and provide compliance guidance to audited parties to encourage process improvement, serve as an expert in the interpretation of GCP and GLP regulatory requirements and expectations
* Manage QA reviews of project?related of essential clinical study documents
* Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures
* Develop and prioritize an audit strategy for all programs in collaboration with the Quality lead
* Plan and lead GCP and GLP compliance audits (world-wide) with external providers as needed, including clinical investigator sites, contract clinical laboratories and CROs to determine compliance status and identify compliance risks
* Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented
* Manage regulatory authority inspections and the coordination of responses to resolve inspection findings, if any
* Report and escalate compliance issues to management, including requests for directed audits
* Participate in quality and compliance improvement initiatives within and outside of Clinical Development/Clinical Operations departments
* Lead Ensure appropriate evaluation of CROs and other clinical service providers as part of the vendor selection process, and serve as SME in the partnership with the CRO
* Provide the GCP support to the development and implementation of E-Systems and new technologies in clinical trials.
* Prospectively identifying critical quality risk factors and potential impact to ensure subject safety and protection and data reliability and validity.

Skills and Requirements:

* BS/BA degree in scientific discipline from an accredited college or university or equivalent experience. Advanced degree preferred
* In-depth knowledge of and ability to interpret and apply GCL, GLP, EU, FDA and ICH regulations, guidelines, and best practices
* Experience in planning and overseeing GCP and GLP audits
* Experience with regulatory inspections and inspection readiness
* Experience with Quality Management Systems (e.g., documentation and record management, change control, deviations, investigations, training and CAPA programs)
* Experience reviewing and auditing study-related documentation (ie clinical study reports, Investigator’s Brochures)
* Strong team player with demonstrated track record of success in a cross-functional team and fastmoving environment
* Excellent organizational, computing and oral/written communication skills
* Ability to influence and negotiate effective solutions
* Strong critical thinking and decision-making skills
* Excellent English communication skills required
* Ability to travel up to 30%

To Apply:
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 +44 203 854 0101 or upload your CV on our website -
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.