Job Description

About Apotex Inc.
Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.
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Job Summary
This is a Quality position for the Richmond Hill site to manage shop floor quality compliance, including oversight of associated Master documentation review and approvals; it is to ensure all sterile and non-sterile manufacturing related 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 the site manufacturing operations.

• Quality oversight of production and associated Master documentation related activities to assure GMP compliance that best support the business.
• Management of retain samples
• Active participation in cross-functional project teams to assure all validation and launch activities are fulfilled in accordance with project timelines
• Interact with regulatory agencies and professional colleagues to review and defend shop floor quality practices in audits

• Develop and maintain thorough knowledge of Canadian and international GMP requirements as they relate to pharmaceutical production. Acts as an expert resource for the organization on regulatory requirements/trends as they relate to shop floor compliance.
• Responsible for application and enhancement of Quality Systems, and establishment of metrics to measure effectiveness of the system.
• Support change through review, assessment and approval of Change Control Requests (CCRs) in TrackWise (or equivalent quality system), as required.

• Develop, maintain and publish performance measures.

• In conjunction with Associate Director, Quality Operations - RH, conduct appropriate resource planning analysis and submits forecasts for headcount, capital and expense budget.Work with the Human Resources group to recruit and hire for open and approved new positions
• Assist Associate Director, Quality Operations - RH in achieving departmental goals and objectives

• 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.
• Manage employee performance / development / administration, which includes, but is not limited to:

• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee's progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• 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 - Collaboration, Courage, Perseverance and Passion.
• 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

• Bachelor of Science Degree in Applied Sciences and/or Pharmaceutical Engineering.
• Knowledge, Skills and Abilities

• Sound knowledge of GMP and current regulatory requirements (from Health Canada, FDA, and EU) on sterile and non-sterile manufacturing
• Excellent command of the English language, both written and verbal
• Superior organizational, time management, interpersonal, communication, and team-building skills
• Customer-service and quality oriented mind-set
• Proven ability to lead and motivate subordinates
• Excellent problem-solving and troubleshooting abilities
• Proven ability to manage multiple priorities and make sound decisions in a fast-paced and changing environment
• Proven success in interacting with regulatory agencies in audits
• Proven experience in project management; proficient with various statistical process control and risk management tools (e.g. FMEA)
• Proficient with Microsoft Office tools (e.g. Word, Excel, PowerPoint, Visio and Access)
• Experience

• Minimum 7-10 years of experience in a GMP-regulated industry, 5 years of which has been spent in Quality Operations (preferably on shop floor).
• Minimum 5 years of management experience, preferably in the pharmaceutical or equivalent industry

At Apotex, we are committed to fostering a welcoming and accessible work environment, where all everyone feels valued, respected, and supported to succeed.
We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Skills Required