Director, Quality Assurance and Pharmacovigilance

3 weeks ago

Mississauga, Ontario, Canada Natco Pharma (Canada) Inc. Full time

Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated pharmaceutical company focused on R&D and the manufacturing of drug products. We are a trusted supplier of medicines evidenced from our work with the world's largest drug companies. Natco is renowned for trust, reliability, and commitment to our customers.

Natco Pharma (Canada) Inc. is headquartered in Mississauga and is supported by a strong cross-functional team.

We are currently looking for a Director, Quality Assurance and Pharmacovigilance to join the Natco team.

Reporting to the CEO, the Director, Quality Assurance and Pharmacovigilance is responsible for maintaining Natco's establishment license by ensuring the compliance of Natco's quality system. The Associate Director ensures that the products sold by Natco Pharma (Canada) Inc. meet the quality standards according to Canadian Food and Drug regulations and comply with current Good Manufacturing Practices (GMP) and Good Pharmacovigilance Practices (GVP). The position is responsible for timely release of products to the Canadian market as well as maintaining the Pharmaceutical Quality System to ensure compliance. The role also includes management of all Pharmacovigilance functions to ensure compliance with the requirements of the Marketed Health Products Directorate.

Duties and responsibilities:

  • Direct , coordinate, and manage all Quality functions to ensure GMP compliance and high Quality Standards for Products marketed by Natco Pharma (Canada) Inc.
  • Ensure all elements of Pharmaceutical Quality Management system are in complaince with Health Canada's current GMP guidelines.
  • Direct all activities involved in releasing of products for sale to Canadian market.
  • Oversee the handling of product complaints and product recalls.
  • Implement Self-Inspection program and Vendor Certification Program
  • Coordinate all Pharmacovigilance activities to ensure Natco's Pharmacovigilance System is in complaince with current GVP guidelines.
  • Prepare and host audits by customers/regulatory agencies and provide responses to audit observations as well as ensuring that all corrective/preventive actions are implemented.
  • Work with other functional areas to resolve issues related to regulatory compliance.
  • Contribute to New Product Launch activities by accomplishing related tasks as needed.
  • Achieve financial objectives by preparing annual Quality and Pharmacovigilance budgets.
  • Communicate effectively with internal and external stakeholders and establish strong relationships to achieve company objectives.

Knowledge, skills, and experience:

  • Canadian university degree or a degree recognized as equivalent by a Canadian university in a science related field
  • A minimum of 5 years of practical experience in Pharmaceutical Quality Control / Quality Assurance / Pharmacovigilance
  • Advanced knowledge of Health Canada Food and Drugs regulations, GMP, GLP, ICH guidelines, US FDA guidelines.
  • Proven experience in internal or governmental inspections and audits.
  • Demonstrated ability to provide clear direction, training, and guidance to motivate direct reports.
  • Proficiency with MS Office.

If you are interested in joining our team, and meet the requirements for this position, please submit your resume to using "Director" in the subject line.

We thank all applicants for their interest in Natco Pharma (Canada) Inc., but only candidates selected for interviews will be contacted. Applications from recruiters or employment agencies will not be considered without a signed services agreement.

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