Global Head of Quality

vor 7 Monaten

Frankfurt am Main, Deutschland Adepto Technical Recruitment Vollzeit

Global Head of Quality - Frankfurt - Permanent

Our client is a global Pharmaceutical manufacturing company based in Europe and the US, who are looking for a Head of Quality to join the company on a permanent basis.

**Main activities and responsibilities**
- Act as a Subject Matter Expert on QMS and Quality Execution Excellence across the our clients network e.g. enhancement of systems / processes, quality standards
- Perform internal audits and offer trainings to the sites regarding new compliance topics.
- Supervise the clients sites on regulatory inspection readiness and inspection management including regulatory responses and action implementation adherence.
- Lead Best Practise and benchmarking activities in the network supporting Quality Culture and cross-functional transformation projects.
- Participate in global Quality projects with focus on continuous improvement and enhancement to the QMS integrating risk management and gap assessment principles.
- Moderate Quality ad-hoc boards for Escalations to Management cases rapidly after notification raised by the sites to ensure and support timely actions, effective communication (if needed) and closure of the issue.
- Model action plans to continually improve performance in KPIs, with specific focus on RFT and overdue compliance activities to minimize Costs of Poor Quality
- Champion the visualization of regular KPI and QMR reporting in an electronic format to increase transparency and enable the build of organizational efficiencies.

**Your Profile**
- University degree or similar qualification with at least 10 years of working experience in a GxP controlled environment
- In depth-knowledge of FDA- / EU-Guidelines and other relevant quality system requirements
- Skills in risk management and gap assessment principles
- Fluent English, with one additional European language
- Flexibility and willingness to travel (< 20%), Internal auditor trained.
- Confident handling in electronic systems, ideally familiarness with Trackwise, LIMS, SAP, eCTD, EDMS
- Excellent interpersonal and communication skills; ability to develop and maintain good working relationships and work productively with others in a team environment.
- highly self-motivated with “Can do” mentality and a strong sense of ownership.

Art der Stelle: Vollzeit, Festanstellung

Arbeitszeiten:

- Montag bis Freitag

Möglichkeit zu pendeln/umzuziehen:

- Frankfurt: bereit sein zu pendeln oder vor Antritt der Stelle einen Umzug zu planen (Erforderlich)

Arbeitsort: Vor Ort

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