Compliance Project Leader

Job Summary

The Project Leader, Compliance is a member of the Richmond Hill Compliance team; responsible for management, monitoring and ensuring compliance of the CAPA system for the Apotex Richmond Hill campus.  This position also supports the compliance and business needs of the Richmond Hill campus with development and analyses of quality metrics data and trending of Quality Performance Indicators  Compliance activities such as escalation, Compliance Review Board meetings, Site Quality Management Review and completion of Risk Assessments to address impact to product are also supported by the role of Project Leader, Compliance.

Job Responsibilities

• Monitor and manage the CAPA system, including evaluation of CAPA records for appropriate plans and actions, monitoring timely completion and CAPA effectiveness. Analyze CAPA data and monitor for emerging trends.
• Communication of metrics and reports to site management.
• Support management to facilitate decision making at the Compliance Review Board, Site Incident Response Committee and Site Quality Management Review meetings. Prepare and distribute minutes, ensuring action items are followed up and decisions documented. 
• Complete Risk Assessments in response to ComAlerts, Supplier Status Review, etc,. to address risk and impact to product.
• Act as a TrackWise Super user and the area SME on the Deviation and CAPA management system, assist other staff members to trouble shoot system issues.
• Provide feedback to the global policies and systems team on the CAPA management system, global policies and procedures. Maintain site procedures related to the CAPA system.
• Provide support for projects related to compliance.
• Provide necessary support during regulatory inspections, including provision of requested documentation.
• Generate data for global quality reports as required.
• Act as back-up for the other Quality Systems Management team members during any absences, ie: laboratory quality reviews and approvals and Annual Product Review (APR) document in adherence with site and global policies and procedures.
• Participate in annual performance appraisals by performing self-evaluations and co-manage own career development.
• Promote communication at all levels and strive to make all information available when and where needed. Build a network of technical support resources throughout the company.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • Bachelor of Science Degree or an equivalent combination of post-secondary education and related work experience
• Knowledge, Skills and Abilities
  • Strong organizational, interpersonal and communication skills.
  • Demonstrated interpersonal skills.
  • Proven ability to manage multiple projects at the same time.
  • Strong understanding of GMP requirements and their application in a manufacturing environment. Knowledge of international GMP requirements.
  • Strong written and oral communication skills.
• Experience
  • Minimum 5 years of professional related experience in Quality Assurance within a pharmaceutical manufacturing environment.
  • Experience in Pharmaceutical Manufacturing operations and controls, quality systems such as change control, APR, validation and/or regulatory affairs.