Associate Director, Manufacturing Quality – GQC – QCR

Role Overview

• Provide on the floor quality support and oversight for manufacturing operations, including aseptic processing, and non-sterile production
• Provide technical and regulatory guidance/direction to QAIP team pertinent to regulatory compliance
• Manage and mentor QAIP team, to provide Quality oversight of sterile and non-sterile manufacturing related activities
• Ensure timely review and approval of batch records, deviations, CAPAs, and change controls
• Responsible for the management of retain samples, including oversight of the governing program and ensuring compliance with applicable regulatory and internal quality requirements
• Monitor quality metrics and trends to proactively address risks and opportunities
• Lead preparation and response efforts for regulatory inspections and internal audits
• Maintain awareness and current knowledge of evolving regulatory expectations, GMP Trends and industry standards associated with Quality and Compliance
• Partner with Manufacturing, Engineering, Validation, to ensure quality is integrated into all processes
• Support technology transfers, new product introductions, and process improvements
• Support Sterility Validation Team and Sterility Assurance group as needed and provide recommendations into the validation activities
• Identify, drive and implement continuous improvement initiatives to enhance efficiency and reduce operational bottlenecks while ensuring Quality and Compliance are always maintained
• Develop departmental budget plans and headcount projections
• Track and manage budget
• Responsible to ensure compliance of team members with Safety and Employment policies
• Performs all work in accordance with Corporate Quality policies and programs and all established regulatory and safety requirements
• Uphold high ethical standards and ensure compliance with ethical guidelines
• Foster a culture of integrity and accountability within the team
• Recruit, mentor, and develop a high-performing team, while fostering a positive and collaborative work environment
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Integrity, Teamwork, Courage and Innovation
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures
• All other duties as assigned

Requirements

• University degree (science discipline)
• Deep understanding of Health Canada, USFDA, EMA, ICH, and other global regulatory requirements
• Ability to lead, manage and motivate others
• Strong organizational, interpersonal and communication skills
• Strong analytical, decision-making, and communication skills
• Experience with Quality Risk Management (QRM), root cause analysis
• Proficiency in electronic quality systems (e.g., TrackWise) and Microsoft Office tools
• Ability to influence across levels and functions in a matrixed organization

Benefits

• Apotex is committed to fostering a welcoming and accessible work environment
• Accommodation for applicants with disabilities as part of recruitment process