Beschreibung
Process Excellence & Compliance Manager - Global Regulatory Affairs (m/f/d)
Reference: -en
Start: asap
Duration: 6 MM+
Main tasks:
- Responsible for the GRA QMS, including implementation of QMS strategy and tactics
- Responsible for supporting and coordinating GRA internal Policy/SOP/WI creation, review, approval, version control and ensuring consistency across
- Regular review of global procedural documents status and analysis of status reports
- Ensure continuous compliance with QMS procedural documents
- Supporting the development of KPIs for key compliance activities and analyze quality compliance metrics
- Represent GRA in global projects, audits and inspections associated with the GRA QMS
- Implement and maintain training curricula for all GRA functions / maintain a GRA training database
- Oversee training status across GRA, collect and analyze regular reports and provide consolidated status report
- Represent GRA in global projects, audits and inspections associated with global training management systems
- Support the implementation of the GRA training governance at all sites globally
- Act as a key contact for internal audits of GRA (e.g. by internal audit groups / third party auditors), including coordination of CAPA responses
- Support regulatory agency inspections including pre-inspection and related follow-up activities
- Coordinate and conduct audits of GRA global processes in order to assess and/or ensure compliance with relevant guidelines, legal requirements and GxP guidelines
- Contribute to audit and inspection readiness activities
- Track audits & inspections performed in GRA
- Oversee and track quality incompliances in GRA
- Track status of CAPAs assigned to GRA resulting from Audits, Inspections and GRA internal sources
Main qualifications
- A degree (min. BSc or equivalent in life science, pharmacy, law or business economics preferred).
- Experience in managing Quality Management Systems including procedural document development, training requirements and conducting audits
- Flexibility to work independently and in teams in a global matrix organization.
- Comfortable working across the business and 2-3 levels above his/her grade.
- Knowledge of ICH guidelines/GCP, related regulatory guidelines and experience in scientific/medical research
- Emonstrated project management skills. Possesses excellent planning, time management & coordination skills
- Demonstrated ability to problem solving and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies
- Fluent in English
- Microsoft Office Skills, focus in Excel skills
Main advantages:
- Reputable international company
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Yves Fabien Deschamps
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