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European Quality Assurance Director

Permanent / Italy

up to

European Quality Assurance Director

We are working with a global Pharmaceutical company who have built a fantastic reputation based on an unwavering focus on clinical development and an ethical approach. The company operated in the top echelons of the Pharma world and had continuously been recognised for its drug pipeline and for being a top employer.

Role:

  • Project management and leadership within quality focusing input to key areas within clinical trial development including protocol amendment review, study documentation content and review, site selection/suitability process, vendor management oversight, and trial conduct and execution activities.
  • Tracking the performance of Clinical trials whether those be in-house trials or CRO managed trials.
  • Assess and identify gaps within Compliance as needed; Recommending training as applicable to improve overall compliance.
  • Work closely with the other Regional Head of Compliance in sharing best practices and lessons learned;
  • Subject matter expert in providing input on new SOPs ensuring compliance for training opportunities for new SOPs.
  • Lead change management initiatives re-lated to process improvement with implementation of SOPs and business guidance.
  • Manage SOP deviation ensuring appropriate documentation is filed and corrective actions are take and applied.
  • Process Expertise ?Establish and maintain regional and global collaborations with partnering organisations
  • Lead and champion new initiatives and processes. Implement process management practices within the region and verify/validate project results.
  • Applicability of training ? Ensure compliance with select quality focused required training by tracking and reporting global GMO status. Identify gaps and assign action where needed to promptly gain compliance.
  • Serve as CAPA Coordinator. Ensuring audits and inspections are supported, tracked and outcomes requiring corrective action are managed.

Requirements:

  • Life science/healthcare degree.
  • Excellent knowledge of written and spoken English
  • 10 years pharmaceutical experience in clinical development
  • requires a thorough knowledge of the overall clinical development process specifically centred around global operations,
  • Detail oriented, have excellent communication,
  • Excellent organization, investigation, and negotiation skills,
  • Good negotiating, networking experience and advanced problem solving skills

 

 

Keywords: Pharmaceuticals, GCP, GXP, GMP, CAPA, API, diagnostic, Italy, Quality, MHRA, Regulatory, Clinical

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email info@life-science.co.uk. We regard all communication and correspondence as confidential. Full job descriptions are available on request.

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Resourcing Life Science is a specialist recruitment agency, providing career advice and employment opportunities within the Pharmaceutical, Biotechnology, Medical Devices and Clinical Research industries across the globe.

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info@life-science.co.uk

0044 (0) 207 421 0000

0049 152 1164 1635

Resourcing Life Science Ltd.
Clerkenwell Workshops,
27/31 Clerkenwell Close,
London
EC1R 0AT