QA GCP Manager (m/f/d).

Job ID: 11536

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Type of employment

We are management consultancy. We are personnel consultancy. We are specialized. On Life Sciences. On Pharma. On MedTec. On LabMed. We work in DACH. In Munich. In Basel. We recognize motives. With candidates. We recognize needs. With clients. We bring people and organizations together. In permanent employment. In projects. In consulting scenarios.

  • Plan, lead, conduct and report audits in the GCP area, such as e.g. investigator site audit, system or process audits and vendor audits and qualification. Audits are performed both internally as well as externally on an international basis. Travel up to 25% expected.
  • Work with contract personnel or consultants to prepare, conduct and report outsourced audits.
  • Support the preparation, coordination and management of regulatory GCP inspections as assigned.
  • Document audits and inspections in the internal audit management e-system, assess responses, and follow-up and track corrective and preventive actions following audits and inspections.
  • Involved in revision of QA processes and procedures including SOPs and risk assessment Tools.
  • Act as Quality Approver for GCP Non-Conformances and CAPAs in the internal e-system for handling of non-conformances and CAPAs.
  • Provide GCP guidance and 
  • M.Sc. degree in Pharmacy, Chemistry, Medicine or other relevant degrees.
  • Fluent in English verbally and in writing.
  • Minimum 5 years of experience from the pharmaceutical industry within GCP/clinical trial responsibilities.
  • Minimum 2 years of audit experience within GCP.
  • In depth UpToDate knowledge and understanding of relevant regulations and quality standards in the GCP area.
  • Extensive experience from working in an international organization and across borders.
  • Preferred experience from working within a Quality organization.
  • High ethical standards, trustworthy, operating with integrity
  • Strong collaborative, partnering, and interpersonal skills
  • Strong communication skills
  • Ability to work independently
  • Ability to prioritize, take decisions and act upon them