Manager, QAIP Manufacturing and Packaging

Manager, QAIP Manufacturing and Packaging Job Summary This is a Quality position for the Richmond Hill site to manage shop floor quality compliance, including oversight of Master documentation review and approvals; it ensures all sterile and non-sterile manufacturing activities are conducted in compliance with current corporate and regulatory requirements. Job Responsibilities Accountable for shop floor quality compliance for sterile and non-sterile manufacturing. Manage the QAIP (QA In-Process) team to provide on-line quality support to site manufacturing operations. Quality oversight of production and related Master documentation to assure GMP compliance that supports the business. Management of retain samples. Active participation in cross-functional project teams to fulfill validation and launch activities on project timelines. Interact with regulatory agencies and colleagues to review and defend shop floor quality practices in audits. Develop and maintain knowledge of Canadian and international GMP requirements; act as an expert resource on regulatory requirements/trends related to shop floor compliance. Responsible for application and enhancement of Quality Systems; establish metrics to measure effectiveness. Support change through review, assessment and approval of Change Control Requests (CCRs) in TrackWise or equivalent system. Develop, maintain and publish performance measures. With the Associate Director, Quality Operations – RH, conduct resource planning and forecast headcount, capital and expense budgets. Work with HR to recruit and hire for open positions. Assist Associate Director, Quality Operations - RH in achieving departmental goals and objectives. Work safely and collaboratively as part of the team to achieve outcomes. Demonstrate behaviours that reflect organizational values: Collaboration, Courage, Perseverance, and Passion. Ensure adherence to all compliance programs including Global Business Ethics and Compliance, Global Quality policies, Safety and Environment policies, and HR policies. All other relevant duties as assigned. Manage employee performance and development; lead performance conversations, monitor progress toward objectives, and support a high-performance culture. Foster open, two-way communication to build trust-based relationships with employees and partners while seeking feedback for development. Attract and hire talent using networks; onboard new employees consistently with company values. Ensure team members’ adherence to compliance programs and company policies. All other duties as assigned. Job Requirements Education Bachelor of Science Degree in Applied Sciences and/or Pharmaceutical Engineering. Knowledge, Skills and Abilities Strong knowledge of GMP and current regulatory requirements (Health Canada, FDA, EU) for sterile and non-sterile manufacturing. Excellent command of English (written and verbal). Superior organizational, time management, interpersonal, communication, and team-building skills. Customer-service and quality-oriented mindset. Proven ability to lead and motivate teams. Strong problem-solving and troubleshooting abilities. Ability to manage multiple priorities in a fast-paced environment. Experience with regulatory agency interactions during audits. Proven project management experience; familiarity with statistical process control and risk tools (e.g., FMEA). Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Visio, Access). Experience Minimum 7-10 years in a GMP-regulated industry, with at least 5 years in Quality Operations (preferably on shop floor). Minimum 5 years of management experience, preferably in pharmaceutical or equivalent industry. At Apotex, we are committed to fostering a welcoming and accessible work environment where everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of the recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation. Additional Information Seniority level: Mid-Senior level Employment type: Full-time Job function: Management and Manufacturing Industries: Pharmaceutical Manufacturing #J-18808-Ljbffr