Quality and Regulatory Affairs Manager

December 6 2017
Industries Pharmaceutical, Biotechnology
Categories Quality assurance and control - Validation, Scientific and Regulatory affairs
Lavaltrie, QC

Responsibilities: 

Quality

  • Ensures compliance of the Canadian commercial division's quality operations and oversees the implementation and application of standards and practices in accordance with commercial Quality Assurance programs, Good Manufacturing Practices (GMP), Standard Operating Process (SOP) and other regulations in place for the sake of releasing product.
  • Coordinate and approve internal and external audits, and track corrective actions related to audits and self-inspections.
  • Act as project manager or project team member in projects concerning facilities, equipment and procedures in order to ensure compliance with GMP while working in a spirit of optimization and profitability.

Regulatory

  • Ensures the development of strategies and controls of internal procedures that will guarantee product supply, life cycle management and product development allowing the Company to comply with the various regulations specific to distributed product lines.
  • Act as project manager or project team member in relation to regulatory milestones related to product development and certification processes, in accordance with the expectations of sales and marketing departments and multi-function projects, in compliance with applicable regulations.
  • Develop and maintain good business relationships with leaders or stakeholders at various levels in the veterinary pharmaceutical industry and various government agencies affecting our industry to be able to know, assess and influence the direction of the industry.

Management

  • Supervise, coordinate and ensure management of his/her department by ensuring the team optimization and performance with regard to missions and objectives.
  • Define and manage the budget of the Department and ensure the improvement of processes to reduce delays, costs and errors, while ensuring compliance with regulations.
  • Act as a member of the Canadian Commercial management committee, participate in the organizational diagnosis and propose means of action and/or changes to achieve the objectives and maximize the profitability.

Qualifications: 

  • University degree in a related science
  • (Animal Science, Chemistry or Biochemistry, preferred)
  • Excellent verbal & written communication (French and English)
  • In-depth knowledge of GMP
  • In-depth knowledge of the Food and Drugs Act
  • Minimum of 5 years of experience in a pharmaceutical environment (regulatory affairs and quality)
  • Staff management and leadership experience
  • Project management experience
  • Relationship building skills
  • Sense of organization
  • Teamwork
  • Self-motivator
  • Analysis abilities
  • Not easily influenced
  • Rigor
  • Knowledge of the MS Office suite and project management software
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