Senior Quality Assurance Manager GCP Europe/Clinical Trials

Senior Quality Assurance Manager GCP Europe/Clinical Trials

TFS

Copenhagen, Denmark

GENERAL DESCRIPTION:

The Quality Manager is a position in the Quality & Compliance Department.

Successful Quality Manager is capable of independently conducting all types of GxP audits including system audits according to company policies, SOPs and regulatory requirements.

This function reports to the: Quality Operations Director

Key Responsibilities:

  • Prepare, conduct and follow up on all types of internal and external GxP audits including system, process, investigator site;
  • Support and guide operational staff in preparing investigator sites for regulatory inspections;
  • Support, guide and facilitate regulatory inspections and customer audits of the company and/or projects;
  • Peer review of audit reports;
  • Provide quality management advice and support to internal and external clients;
  • Participate in internal meetings as required and liaise with other departments as necessary;
  • Develop new and review existing Quality & Compliance SOPs as required;
  • Maintain required knowledge of applicable regulations and company GxP standards and procedures;
  • Assist in writing SOPs for other departments;
  • Assist with business development of external quality and compliance services;
  • Accompany Commercial Operations colleagues on customer visits and participate in presentations when required;
  • Actively contribute to continuous improvement of the TFS Quality Management System (QMS).

REQUIREMENTS

  • University/college degree or equivalent industry experience;
  • Awareness of global and local industry trends, government policies and regulations in the clinical trials and pharmacovigilance area;
  • In depth knowledge of GxP regulations and guidance;
  • Previous pharmacovigilance auditing experience is required, with thorough knowledge of requirements for PV compliance;
  • Knowledge on GxP regulated computerized system validation activities and principles;
  • Previous audit management experience;
  • Good computer skills (Microsoft Word and Excel);
  • Ability to work independently and efficiently;
  • Good planning, organisation and problem solving abilities;
  • Fluent in English, both written and verbal;
  • Several years’ experience in clinical research, (e.g. monitoring, data management, drug safety, training, etc.);
  • 5+ years’ experience of auditing in two to three GxP areas;
  • International travel to audit sites, worldwide;
  • Delegated for other tasks and activities by Quality Operations Director within scope of experience.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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