Quality Management System Manager

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About the job

  • UK
  • Competitive USD / Year

The QMS Manager will manage and coordinate quality aspects of our client’s business operation, including management of the company’s quality management system and monitoring of key performance indicators to ensure a well-controlled and time-managed system. They will ensure quality compliance throughout the business in compliance with the 2013/C 343/01 EC Guidelines on Good Distribution Practice of medicinal products for human use and Directive 2003/94/EC for the QMS system. The successful candidate will also hold direct line management for the Senior Quality Assurance Officer for compliance.

Key Responsibilities

  • To ensure that a quality management system is implemented and maintained and appropriate to the activities at the Company inclusive of the EU Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use (EudraLex Volume 4, 2003/94/EC).
  • Maintenance for the awareness of new and revision to existing quality directives: (E.g. Medicines directive 201162EU, Directive 2003/94/EC and EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.
  • Develop and maintain a series of KPIs for each area of the QMS. Produce monthly reports for the QMS review meeting.
  • Chair and be responsible for the effective running of the monthly cross department QMS compliance meetings.
  • Monitoring and compliance of deviation, CAPAs, change controls, risk assessment, complaints, recall, documents, approvals and bona fides.
  • Maintain employee training records and coordinate the compliance of employee training with regulatory requirements.

Qualifications, Experience & Knowledge Required

Understand the role of the HPRA, MHRA, and other competent authorities, in the licensing of medicines, including the risk-based inspection process, the role of the enforcement group, the Inspection Action Group (IAG) and resulting actions that can be taken due to non-compliance.

  • Good understanding of GMP / GDP
  • Relevant knowledge and experience related to the distribution of medicinal products.
  • Good understanding of customer requirements and certification for products traded under the Company WDA.
  • Be a member of a professional body with a published code of conduct.
  • Good interpersonal and communication skills to communicate complex information to others and be able to put across ideas in a clear and concise manner and present a well-structured case.
  • Ability to work under pressure and to tight time deadlines with prioritisation of work. Excellent attention to detail.
  • Effective time management.
  • Proficient IT skills.
  • Skills in English language and writing.
  • Degree level in a Life Science subject or equivalent in relevant experience.

Interested to learn more? Apply today.