Associate Manager, GCP Compliance

Associate Manager, GCP Compliance

A fantastic opportunity has arisen for an Associate Manager of GCP to join an International Biotechnology company focused on the development and commercialisation of unique products to address unmet medical needs.

The Associate Manager will manage all aspects of clinical compliance and QA activities, including documentation review, internal process audits and external site and vendor audits and follow-up, providing guidance to clinical operations, ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, SOPs, and study requirements.

Main Responsibilities:
* Manage and assist in implementing and maintaining a comprehensive GCP compliant quality program
* Assist in setting annual audit schedule and preparing necessary budget
* Manage and conduct external site and vendor audits according to SOPs
* Assist in preparing audit responses and evaluating adequacy of corrective actions
* Identify and assist in developing SOPs and systems needed to comply with regulatory requirements.
* Manage and conduct internal clinical process audits according to SOPs
* Perform quality reviews of protocols, case report forms and other supplemental study documentation
* Perform quality audits of data tables and study reports
* Manage other team members

Experience Required:
* At least ten years of relevant pharmaceutical industry experience which includes at least four years of direct quality assurance or regulatory compliance experience.
* Working knowledge of GCP/ICH regulations and guidelines and international regulatory practices.
* Commitment and ability to handle high workloads, stressful situations, and deadlines.

This is a newly created position for my client.

To apply for this role please upload a recent CV or call Rachael Young on 020 7758 7311 for a confidential disucssion.

KEYWORDS: Quality Assurance, QA, Quality, Assurance, GCP, Good laboratory practice, testing, QC Manager, QC Associate, QC Analyst, Quality Controller, Manager, director, pharma, pharmaceutical,CMO, contract manufacturing, Qualified Person Services, Quality Assurance, Regulatory Affairs, QA, GxP's, SOPs, Systems, Quality Management, Product Release,GMP, Good Manufacturing Practice, Quality Assurance Manager, Qualified Person, Audit, Auditing, Validation.

To find out more about Real Staffing please visit www.realstaffing.com