Associate Director, Quality Assurance (GCP) – Global Pharma, London

Recruiter
Just Pharma
Location
All Saints
Posted
17 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
My client, a world leader in the development of novel drug therapies for a variety of therapeutic areas including a pioneering therapy in Oncology, are looking to offer this position on a full-time, permanent basis. They are willing to offer highly competitive salaries as well as comprehensive benefits packages, and this is an excellent opportunity for an experienced GCP Auditor to develop their career within a variety of therapy areas. Accountabilities Prepare for and conduct QA audits (10-15 per annum) and follow up with reports, ensuring that the results are communicated and issues are dealt with. GCP routine/directed audits of investigator sites, COs, vendors, regulatory documents and 3rd party collaborations. Act as the single point of contact for QA for assigned therapeutic areas/projects, or for select countries. Contribute to global QA strategy and Quality Management with regards to GCP and ensure company alignment through extensive cross-functional communication. Development and continuous improvement of internal QA procedures and audit tools to ensure global consistency. Act as a strong SME to resolve any GCP issues based on knowledge of SOPs, GCP, PV and country regulations. Train/mentor junior QA staff. The position in itself will involve 30% - 50% of travel time throughout the EU predominantly, with rare travel to Russia and areas in Asia for audits/QA meetings. Reports into the applicable TA Quality Assurance Head. Qualifications BSc or equivalent. Proven experience of GCP auditing with a knowledge of global regulations. Extensive experience in Clinical QA. Experience in a variety of therapeutic areas and PV experience is preferred. Quality, QA, QC, Quality, Standard Operating Procedures, Specialist, Director, Sr Manager, Management, Individual Contributor, Global, International, Mgr, Management, Senior Manager, Lead, Matrix, Clinical, QMS

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