Manager, Quality Assurance & Compliance

Job purpose

The Manager, Quality Assurance (Compliance) is responsible for management and execution of key compliance Programs in Sun Pharma Canada Inc. as per Health Canada requirements.  In addition, the individual in this role is responsible for managing the processes associated with electronic systems used by Sun Pharma Canada Inc. organization. The Manager, Quality Assurance (Compliance) is also responsible for management and execution of all CAPAs associated with Health Canada inspections, internal audit and self-inspection program ensuring their timely closure and effectiveness check. This role provides support regarding communications with Health Canada and regulatory/customer/internal audits management.

Duties and responsibilities

• Manage and Execute Annual Product Review Program:
  • Develop, monitor and execute tracking management strategy for APQRs
  • Communicate with Sun Pharma sites and CMOs and ensure APR receipt as per the schedule
  • Perform analysis of the provided information and add post-release product data, issue APR Executive Summary
  • Identify risks and work with the product manufacturers on the corrective actions
  • Provide APR information to Sun Pharma Canada Inc. customers, as required
  • Maintain site SOP on this subject, as required.
• Responsible for Global Documentation Implementation and Site SOPs
  • Review the list of the global Quality Standards and SOPs and identify the list for implementation
  • Manage gap assessment process and ensure completion of all implementation associated activities
  • Provide all completed forms for review and approval as per the established process
  • Develop and maintain site SOP, as required
  • Revise site SOPs and related documents, as applicable (e.g. adhoc revisions and periodic reviews)
• Sun Pharma Canada Inc. (SPCI) Electronic Document Management System (EDMS)
  • Perform role of EDMS Site Coordinator, as assigned.
  • Perform workflows as per GSOP000160 Document Management in Electronic Document Management System (EDMS - 21.2).
• QMS TrackWise System
  • Perform role of TrackWise Coordinator, as assigned.
  • Perform workflow for User Access Management records in TrackWise.
  • Communicate system related information to end users.
  • Provide workflow trouble shooting support to end users, as required.
• Change Control Program Management
  • Ensure review and approval of the change control records and their appropriate content, risk-based impact assessment and associated actions
  • Ensure appropriate personnel training and access in global QMS Trackwise
  • Maintain site SOP on this subject, as required.
• Corrective Action and Preventive Action (CAPA) Program
  • Develop and maintain Quality and Compliance metrics
  • Ensure appropriate trend analysis as an outcome of the established compliance Programs and identify appropriate CAPAs to continuous improvement process
  • Own and execute CAPAs associated with Health Canada, Internal Audit and Self-Inspection observations
• Sun Pharma Canada Inc. (SPCI) Learning Management System (LMS)
  • Perform role of LMS Local Training Coordinator (LTC), as assigned.
  • Perform workflows as per GSOP000063 Management of Training Activities in Learning Management System (LMS).
• Sun Pharma Canada Inc. (SPCI) Training Program Management
  • Establish training needs assessment process and identify training gaps
  • Develop, report and maintain training metrics
  • Manage the implementation of the Corporate Quality training courses and manage annual GMP training program as per training needs assessment
  • Prepare and maintain annual Integrated Training Calendar (ITC) and attend GMP forum meetings on behalf of the department
  • Act as a Single Point of Contact (SPOC) for Sun Pharma Global Certification Programs and ensure their successful execution and effectiveness
  • Develop and maintain site SOP on this subject, as required.
• Additional duties as assigned

Additional responsibility (Only applicable to customer facing roles)

• Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• Background and Experience
  • Minimum University level degree (B.Sc.) in a Science or Pharmacy discipline applicable to Health Canada standards 
  • Minimum 7+ years of experience in Quality Assurance department working under Health Canada GMP regulations
  • Experience in dealing directly with Regulatory Agency officials (Health Canada)
• Knowledge, Skills and Abilities:
  • Excellent communication skills (written and oral) including presentation skills, technical writing, organization and negotiation skills
  • Compliance Programs/Project management experience
  • Proven problem solving ability with evidence of good judgment and decision making skill
  • Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines 
  • Excellent working knowledge of GMP and regulatory requirements for the pharmaceutical industry
  • Strong proficiency with applicable computer software

Working conditions

General office based conditions

Physical requirements

Hybrid model - 3 days in office and 2 days work from home

Direct reports

NA