Associate Director, Mfg Quality-GQC-QCR R

Job Description

Job Summary

The Associate Director of Manufacturing Quality is a strategic leader responsible and accountable for quality assurance activities across sterile and non-sterile manufacturing operations. This role leads the manufacturing quality team, ensures compliance with global regulatory standards, drives continuous improvement, and fosters a culture of quality excellence. The Associate Director partners cross-functionally to ensure quality is embedded in all aspects of manufacturing and packaging.

Job Responsibilities

• 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 Asssurance 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.

Job Requirements

• Education
  • University degree (science discipline).
• Knowledge, Skills and Abilities
  • 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.
• Experience
  • Minimum 7 years’ experience in the pharmaceutical industry with at least 5 years of experience in sterile operations
  • Minimum 2 years of Sterile, Quality oversight experience would be an asset
  • Proven leadership experience in a GMP-regulated environment.