Leader – Pharma Product Development Process Validation

Employment Permanent Date display: 28/01/2019 #Ref.:2894

Activity area : Pharmaceutical and medical

Post category : Production and engineering, Scientific and technical positions

Province : Ontario

Region : Toronto

Recruiter : Anne Loiselle

Contact us : aloiselle@hubbletalent.ca

Job description :

Our client is a major pharmaceutical company with a global presence producing and marketing both generic and innovative pharmaceuticals.   They are looking for an Associate-Director to lead the process validation (PV) of pharmaceutical new development and product lifecycle for a very large and growing portfolio.   In this role, you would lead a team of over 20 PV professionals responsible for the compliance with cGMP regulations.   You would ensure that all the manufacturing sites adopt and follow consistent process validation aligned with the company’s standards and procedures.   You would have interactions with international regulatory agencies (FDA, Health Canada, EMA, etc.) and be responsible for the continuous PV compliance strategies.

Your responsibilities would also include supporting the client’s mission and vision, and working with internal multidisciplinary team (e.g. Supply Chain, RA, QA)

Skills and qualifications :

  • Strong decision-making skills.
  • Ability to proactively identify opportunities for process improvements and solutions to problems.
  • Strong leadership skills. Experience recruiting, developing and managing a large team.
  • Development and management of budget.
  • Multi-tasking and flexibility.
  • Scientific degree (e.g. Pharmacy, Pharma technology, Organic Chemistry, Chemical engineering).
  • Minimum of 10 years in cGMP Process Validation.
  • Experience in oral solid dose (required) and oral liquid (desired).
  • Expertise in CMC regulatory guidelines (incl. FDA, EMA and Health Canada).
  • Excellent organization, troubleshooting and report writing skills.