Director, Operational QA Network Management

€120000 - €130000 per annum
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. Germany
Mainz, Germany
Posting date: 01 Feb 2024
58684

Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis. The opening position currently available is for a Director, operational QA Network Management.

Responsibilities:

  • You will lead by example and be a proactive and visible Quality Leader.
  • Communicate and direct decision-making procedures for network partners in GMP query, which involves onboarding partners, new products execution and technology transfer.
  • Assist the responsible persons for release as the first QA expert contact for quality events.
  • The ideal candidate will serve as a quality representative of the company within both external and internal manufacturing networks as a marketing authorisation holder.
  • Train and teach QA Managers to accomplish the next level and develop themselves as QA experts within the manufacturing and testing operations.
  • Guarantee assessment of quality events and notification from the network's partners.
  • Implement and ensure seamless communication t the company's business partners, CMOs and internal divisions to guarantee product release in a compliant and timely manner.
  • Other duties may be assigned.

Key Skills and Requirements:

  • Educated to a degree level in a life science, engineering or medical discipline.
  • Know-how of pertinent US and EU guidelines, EMA, FDA and any other regulatory standards as well as GMP.
  • Demonstrable experience within quality assurance, quality oversight or corresponding, preferably within a biotech or pharmaceutical organisation with respective knowledge.
  • Familiarity with both external and internal contract manufacturing organisations, which involves expertise on CMO operations and release testing.
  • Works well with others both internally and externally in a cross-functional matrix team, as well as abilities in shareholder management.
  • Tactical and operational abilities with the capacity to make flexible but thorough decisions in a dynamic setting.
  • A high attention to detail.
  • Fluency in both German and English.
  • Presentation and communication skills both verbally and in writing towards a varied audience.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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