(Senior) Manager Quality Operations & GDP Deputy RP

Highly Competitive
  1. Contract
  2. Good Distribution Practice (GDP)
  3. France
Aubonne, France
Posting date: 06 Nov 2023

This vacancy has now expired. Please see similar roles below...

Proclinical are partnering with a biotech organisation who are currently recruiting for an individual to join their team. This role is on a contract basis and is located in wither Switzerland or France. The opening position available is for a (Senior) Manager Quality Operations & GDP Deputy RP.


  • Supervise quality systems for trends and give notice to management of events needing immediate action.
  • Handle events, changes, CAPAs mediating with the pertinent functions of the business unit, production units and suppliers.
  • Assist with the tech transfer, such as DS and SP for biosimilars, as well as analytical method transfer and offer quality oversight for GMP compliant implementation.
  • Offer quality assistance guaranteeing smooth transition from development to commercial.
  • Gather key quality/compliance indicators for periodic evaluation of local quality management systems.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to a degree level in a technical, engineering or similar discipline.
  • Demonstrable experience within a quality function with increasing levels of accountability within a biotech, life science or pharmaceutical organisation.
  • Comprehension of quality standards, for example: ISO 9001, ISO 13485, ICH Q8, ICH Q9 & ICH Q10, etc., cGMP & GDP needs for Pharmaceuticals and Combination Products, which involves Biologic Products.
  • Comprehension of GMPs and best quality practices concerning biotech manufacturing procedures.
  • Familiarity with regulatory agencies, for example: FDA, EMA, etc.
  • Exhibited background within third-party's quality management.

If you are having difficulty in applying or if you have any questions, please contact Ayesha Kippie at +41 615 687 995

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.