**Quality Assurance Manager - GCP - Exciting, Global Company - Central London!**
Company: Advanced Clinical Recruitment Ltd
Location: Central London
Closing Date: 15 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent Salary & Package
I am currently recruiting on behalf of a very interesting and exciting Global client, based in Central London, who are looking for a Quality Assurance Manager to join their successful and expanding team! This professional will be at the centre of the QA team's growth, with one direct report and more to recruit. The experience required is a strong GCP background ideally with Quality and QMS expertise. The role will be based in a fantastic location in Central London, with some flexibility offered.
Role and Responsibilities
- Take ownership, develop and maintain and continually improve business processes and procedures.
- To ensure quality compliance against Good Clinical Practice (GCP), clinical trials regulations and MDD expectations; e.g., EU Directives, CFR 21 Parts 11 and 312, along with guidelines and other applicable external legislation and standards e.g., ISO 9001, ISO 13485, ISO 14971, MDD 93/42 EEC and Data Protection legislation.
- Provide GCP, MDD and regulatory expertise, guidance and training for the company.
- Implementation and maintenance of all aspects of the Quality System and SOP life cycle including (but not limited to) process development, review, implementation, training, monitoring of process compliance e.g., via evaluation of SOP deviations, revision and decommissioning of SOPs.
- Updating, maintaining and improving the Quality manual and process content on our document management system.
- Implementation and maintenance of the QA and Compliance Strategy including (but not limited to);
- Defining, maintaining and periodically reviewing the strategy for effectiveness.
- Take ownership of the internal and key suppliers auditing schedule and process.
- Host and manage audits by potential and on-going customers and regulatory inspections.
- Support implementation and oversight of Corrective Actions and / or Preventive Actions and other issues that may impact quality.
- Identify those areas of quality processes that need to be improved and propose new ways to improve quality, while maintaining those processes and systems that are working.
- Ensuring that the quality system is established, implemented, maintained and monitored in accordance with relevant standards.
- Monthly reporting to senior management of quality and regulatory metrics and issues; e.g., non-conformities and progress in resolving these through monthly reporting.
- To prepare and conduct with top management, reviews QMS at planned intervals to ensure its continued suitability, adequacy and effectiveness. ?
Skills and Experience
- Extensive experience as a quality professional in the pharmaceutical regulatory environment, and has held Quality / Regulatory positions for more than five years.
- Experience within both large pharmaceutical companies and CROs is desirable.
- Extensive experience of definition and maintenance of Quality Management Systems, audit planning and management and the clinical trials process.
- Excellent understanding of GCP and clinical trials regulation and compliance requirements.
- Experience of ISO 9001 / ISO 13485 Quality Management Systems.
- Experience of managing external (client) audits and regulatory inspections.
- Ability to work in a small company environment and influence at all levels in the organisation.
- Ability and experience to drive the Quality and Regulatory Compliance agenda.
- Experience in submissions to regulators and interaction with regulators is desirable.
- Strong organisational skills and the ability to multi-task with a goal-oriented approach whilst maintaining attention to detail.
- Ability to prioritise and manage tasks/requests for support and sometimes competing demands.
- A strong team-player. Proactive and personable.
- An excellent communicator able to influence others to bring about quality improvements.
- Highly IT literate, methodical, meticulous and a completer finisher.
For further information on how to progress your career through this excellent opportunity, within a fantastic organisation, please contact me ASAP for a completely confidential conversation! Alternatively, to apply directly, please send through an updated copy of your CV, and I will do the rest!
Sam Caley - Advanced Clinical Recruitment
+44 (0) 114 270 1741
LinkedIn Search: Sam Caley Quality Assurance
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