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Qualifications Manager (M/F)

October 27th 2020

Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medicinal products. We assist our clients from candidate selection, through non-clinical and clinical studies, to marketing authorisation, using our state-of-the-art, product-dedicated expertise in analytical sciences. For each customer and each project, we design customised solutions, define analytical protocols, develop and validate specific new analytical methods and perform characterisation, stability, pharmacokinetic, biomarker and immunogenicity studies as well as batch release testing, in order to evaluate the Quality, Safety and Efficacy of the given drugs. The company holds a unique position on the market with all its laboratories on one site, 200 highly qualified professionals and over 35 years’ expertise at the forefront of analytical sciences. The Quality Assistance environment is GMP, GLP and GCLP/GCP compliant.

Mission Description

You will report to the Technics Director
You will manage a team of 12 people (Technical Leaders, Qualifications Experts, Quality Associate, Technicians).
In this role, you will be accountable for:  Co-ordinating projects and resources according to defined priorities o Planning of team activities o Participating in technical troubleshootings o Managing quality documentation including SOPs updates, CAPA, Change Control, Deviations, … o Validating qualifications analysis reports  Managing all HR aspects such as o Participation to selection interviews o Staff evaluation o Ensuring coaching meeting with staff members o Career development plan follow-up

  • Participating to new lab equipment purchase (URS, DQ, IQ, OQ, PQ)
  • Being the point of contact for internal client
  • Participating to internal and clients audits and regulatory inspections

Candidate profile

Bachelor or Master’s degree in Sciences or Applied Sciences Required

  • Minimum 5 years of practical experience working in Lab Equipment Qualification in a regulated environment
  • Minimum 2 years of experience in a people management role
  • Strong organizational skills with ability to manage projects through wise planning, time optimization, detail orientation and prioritization.
  • Strong leadership with ability to train and mentor staff
  • Very good communication skills both in French and English (writing documents, mails, phone conferences, audits…) 

Offer

  • We are a true career partner.
  • We accelerate people’s access to new medicines.
  • We offer an inspiring work-life balance in a human scale environment.
  • We care about mutual respect, assistance and communication.
  • We listen to your needs and your suggestions.
  • We offer a market-competitive remuneration package including numerous fringe benefits.

Contact Details

Send your application (reference JOB224) now to Mr Bernard Adant, Talent Manager, to recrutement@quality-assistance.be or consult the Careers page on our website http://www.quality-assistance.com/careers/jobs.
Address: Technoparc de Thudinie 2, 6536 Donstiennes, Belgium