Head of GQA Medical Device

Head of GQA Medical Device

Ferring Pharmaceuticals

Saint-Prex, Switzerland

Your Mission:

Lead and manage the GQA team overseeing the QA roles in Ferring Medical Device activities, securing Ferrings license to operate in the area building an effective and compliant Quality System and assuring its implementation in IPC -DK, FICSA, and relevant Manufacturing Sites, R&D and M&S sites. Provide QA support to Medical Device business functions and develop and train Ferring organization in Medical Device regulations.

Responsibilities and duties:

Compliance:

  • Lead quality and compliance oversight and generated initiatives globally to improve quality and compliance in medical device activities;
  • Drive the global transparency to quality and compliance issues for devices;
  • Assign GQA representation in R&D projects and other relevant projects within Global Technical Operations, and GQA;
  • Proactively contribute to Device supplier assessments, Involved in Supplier Technical Quality Agreements and device supplier auditing;
  • Drive inspection readiness activities prior to audits by Notified Bodies and inspections by health authorities;
  • Lead response board for inspections and has responsibility for effective communication of observations and learnings;
  • Participate in the decision-making process of recalls and critical issue investigations;
  • Appear in relevant product recall committees, and Drug Safety Teams;
  • Support the local QA operations (e.g. complaints, Deviation/CAPA, CR, vendor assessments) mainly in manufacturing Sites and central function by guidance, coordination and escalation. Where appropriate, direct involvement in QA review of CR, Deviation/CAPA, device documentation;
  • Coordination of the global audits program for medical device internal and systems audits;
  • Ensure global peer review of audit report ensuring aligned audit output and high quality of audit reports.

Performance Management: Within own responsibility are:

  • Contribute to Quality Reporting monthly reports, Compliance Board reports, Quality Review Boards Manage and develop the team’s roles and involvement in GQA and local site operational activities;
  • Delegate responsibilities and tasks to secure the team’s performance on its deliverables;
  • Ensure optimal collaboration and utilization of the team’s competences · Ensure development of the team competences and performance;
  • Member of MDOT representing GQA and LQA on both Development and Commercial Product topics Prepare monthly reporting of relevant topics to the GQA report;
  • Follow up and ensure escalation of quality issues in GQA , Device R&D and Project organization Support the local QA operations ( e.g. complaints, Deviation/CAPA, CR, vendor assessments) mainly in manufacturing Sites and central function by guidance, coordination and escalation;
  • Where appropriate, direct involvement in QA review of CR, Deviation/CAPA, device documentation.

Interface management:

  • Report of Critical Observations and issues to Top Management;
  • Interface with global function at Senior director and VP level;
  • Act as opinion leader in the promotion of the Quality Management ideals, concepts and practices;
  • As part of GQA R&D, engage in driving the GQA objectives to the Ferring Sites;
  • Establish and maintain a global forum to ensure involvement and alignment between the global and local Site QAs for Device activities;
  • Ensure sharing and coordination of device supplier audits, and audit follow up.

Regulatory Watch:

  • Carry out systematic regulatory watch to implement new regulations to the QMS system;
  • Benchmarking with peer industry to keep updated industry standards and effective quality assurance tools.

Required Experience & Competences:

  • Master of Science or equivalent degree in engineering, pharmacy or in another life science field;
  • Minimum10 years of experience from relevant Industry including QA;
  • Expert knowledge in medical device development, medical device regulation;
  • Experience as a team leader for a team of expert professionals;
  • Strong Knowledge Pharmaceutical and device industry regulations in general (EU, FDA and others);
  • Fluent in English speaking and writing;
  • Excellent interpersonal and communication skills;
  • Strong business mind-set with demonstrated ability of conceptual and strategic thinking.

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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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