HEAD OF QUALITY ASSURANCE (H/F)

HEAD OF QUALITY ASSURANCE (H/F)

From 2001 Baccinex SA is a constantly growing pharmaceutical contract manufacturing organisation in the field of sterile manufacturing of liquid and lyophilised finished products. During the last 20 years Baccinex imposed itself as a leading actor on the niche market of sterile clinical batches manufacturing as well as high value API sterile commercial batches. Our clients are major players of the biotech and pharmaceutical landscape in Europe but also US and ROW. We are located in Switzerland in the Canton of Jura in the French speaking area, close to major pharma clusters such as Basel, Zurich, Lausanne.
We are currently recruiting a

HEAD OF QUALITY ASSURANCE (m/w/d)

 

Your Responsibilities:

  • Assure the overall management of all aspects of Baccinex SA Quality Assurance System to secure overall regulatory compliance to GMP (EU/US) at all times for the entire site
  • Optimize the actual quality system to guarantee complete QA overview
  • Responsible for defining the QA strategy and its implementation
  • Provide leadership and manage a team of about 20 persons
  • Be an escalation and decision point for all matters related to quality
  • Heading of the GMP Quality Assurance Team and management of that Team covering all GMP related activities, such as:
    • Organization of QM systems for deviations, CAPAs, changes, OOS and complaints according to GMP regulations
    • Hosting external client audits and inspections of health authorities
    • Planning, implementation and follow-up of corrective actions resulting from audits and authority inspections
    • Regular reporting to senior management
    • Securing the compliance according to client requirements together with relevant internal stakeholders (e.g. Head of Production, Head of QC, Responsible Person (QP), group leaders, project managers)
    • Organize and assure in a proactive manner the follow-up of the EU and US regulatory environment trends and evolutions

 

Your qualifications and skills :

  • Degree (Master or higher) in Pharmacy or life sciences
  • Excellent knowledge of GMP (EU/US) and relevant regulations (e.g. PhEur., USP, CFR, PIC/S, ICH)
  • Familiar with the various Quality Assurance Systems including: Risk Management, Continuous lmprovement, Management Awareness, Audit & lnspections, Change Control, Deviation Handling and CAPA.
  • Proven experience of 5-10 years in senior and/or leading position in pharmaceutical Quality Assurance, ideally in sterile finished products
  • Excellent written and verbal knowledge of French and English
  • Very good MS Windows and Office skills
  • Very good organizational skills and assertiveness
  • Self-starting personality and solutions-oriented approaches
  • Demonstrated project management skills with the ability to communicate and collaborate with multiple stakeholders
  • Strong oral and written communication and motivational skills

Candidates will be specifically challenged on each one of these skills during recruiting process.

 

We are looking forward to receiving your application at:
BACCINEX SA, Ressources Humaines, Rue de la Source 3, 2822 Courroux or by clicking on the button « envoyer ma candidature »

Applications must include a motivation letter and CV. Baccinex is committed to provide equal employment opportunity for all.

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