Job Details

Director, Commercial Affiliate QA GMP GDP and Qualified Person

4804
  • ₣180000
  • basel, Switzerland
  • Permanent

QA Director

 

Location: Basel, Switzerland

Start Date: ASAP (permanent position)

Up to CHF 180k

 

A global, innovative biopharmaceutical company are searching for a driven QA GMP expert to provide vital strategic input across all EU affiliate sites. Within this role you will be responsible for ensuring the highest Quality and Regulatory standards (GMP, GDP, PV) are maintained across the sites as well as the optimisation and implementation of a standardised QMS.

 

What is it like to work here?

  • Gain the opportunity to work across several therapeutic areas including cardiovascular, immunology, and neuroscience.
  • Experience for yourself what it’s like to work in a company that is internationally recognized as a 'top employer'.
  • Enjoy being part of a collaborative work environment.

 

What will you be doing?

  • You will be the prominent figure for ensuring affiliate QMS compliance in line with the company’s and industry Quality standards and local PV, GMP, GDP regulatory requirements.
  • Use your expertise in collaboration with local Responsible Persons and Qualified Persons to ensure continuous inspection readiness.
  • Support internal and external audits and inspections.
  • PV vendor management, ensuring they are appropriately qualified & audited.
  • You are expected to ensure timely management of deviations, CAPA, change controls and Quality events.
  • Batch record review, deviation review and approval, batch release.
  • Liaise with multiple internal departments and external stakeholders.

 

What do you bring to the table?

  • Strong working knowledge PV regulations (including product complaint and recall management), as well as GMP/GDP requirements.
  • Graduate degree in Pharmacy or related degree.
  • Demonstrable pharmaceutical industry experience.
  • Qualified person (requirement).
  • Excellent communication skills.
  • Fluent in English and German, French also desirable.
Robyn O'Toole Recruitment Consultant

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