QA Manager

  • Location: Mont-Saint-Guibert
  • Type: Perm
  • Job #17508

Our partner is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely, on time and wherever they are needed in the world.

Role

  • Ensure the availability, the update and continuous improvement of the quality management system
  • Lead the site Quality (Management) Review board
  • Function as Quality department liaison and subject matter expert to other department representatives, QP’s/RP’s, customers, and regulatory representatives in relation to Supplier qualification, self-inspection, Agency inspections and customer audits
  • Contribute to the quality department's activities to ensure continuity of operations
  • Know, understand, and comply with the company’s standard operation procedures and policies
  • Perform and contribute to qualification of suppliers and vendors
  • As required, participate in the Quality Management System, including Change Controls, Non-conformances (including root cause investigations) and CAPA
  • To participate in the self-inspection of the Quality System and to carry out independent audits of external vendors as required
  • Support Client hosted audits and Competent Authority inspections, covering preparation, participation and follow-up/CAPA
  • Train/coach/develop and evaluate direct reports and provide timely and compliant employee counselling as discipline and performance issues arise
  • Identify and support the implementation of improvement opportunities, collaborating with the business areas, to form a strong and effective operational excellence team dynamic
  • Maintain paper and electronic records for quality documentation
  • Manage ad-hoc Quality projects

Requirements

  • Pharmacist´s degree or equivalent degree in life science study, e.g., Veterinary or Biology
  • Experience (10 years) in Quality Assurance or in an equivalent function (operations for instance)
  • Experience in leading Quality audits/inspections-internal and external. Ideally as qualified auditor
  • Experiences with clinical trials and IMP. Experienced in GMP and GDP, GCP is a plus
  • Experience in working in a matrix organization
  • Pragmatic
  • People management
  • Excellent communication and intercultural skills
  • Resilience
  • Ability to find compromises
  • Team worker and team spirit
  • Customer oriented
  • High organizational and planning skills
  • Work with accuracy and reliability
  • Good dose of assertiveness
  • Good computer skills: MS office, other office software
  • Fluent in French and English. Any additional language is an asset

If you are interested, you can send your resume to Dimitri Soupart : [email protected]

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