Job Description

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: .

Job Summary

The Manager, Quality Systems Management is a member of the Quality management team and is responsible for continuous monitoring and improving overall compliance at the site; managing the process, people and systems to provide Change Control services related to commercial documents and data for the manufacturing site; managing the review and approval of Apotex metrics and CAPA programs, compliance initiatives, regulatory/customer audits, QC Laboratory Investigations and CAPA, SOD Management Program and managing the Annual Product Review (APR) program.

This position ensures compliance in accordance with GxP, regulatory standards and Company policies and procedures. This Manager provides coaching and direction for Quality and manages the activities of resources to support the compliance and business needs of the site including audit support. In addition, this Manager is responsible for implementation of all aspects of Quality Compliance programs across the site and acts as a champion for building a "culture of quality" across the organization

Job Responsibilities

• Manage the escalation process, inclusive of the SIRC, in adherence to site and global policies and procedures.
• Management of the SMR Meetings , risk registry and QRRB to ensure senior management team at the site have visibility on process performance, product quality and effectiveness of the pharmaceutical system
• Develop and maintain business metrics, QPIs and reporting tools to monitor and review compliance activities such as deviation and CAPA management at the site. Lead change to respond to issues and concerns identified, ensuring consistency with quality programs and regulatory requirements
• Establish performance metrics and departmental objectives that support the corporate and quality goals.
• Provide necessary support during customer and regulatory inspections, which may include provision of pre-requested documents, perform key audit roles/functions, follow-up on audit observations related to compliance issues
• Manage the process, people and systems to ensure Change Control & Documentation Management at the site remain in compliance and and periodic review is managed.
• Managing the review and approval of QC Laboratory Investigation Reports (LIR) & QC Laboratory documentation at the site level including method validation & technology transfer protocols/reports, test methods, specifications and change controls, to ensure they are completed in a compliant and timely manner to support business priority
• Oversee management of the Annual Product Review (APR) program.
• Liase with other business units (Commerical Operations, Technical Operations, Regulatory Affairs, Process Validation, Quality Control Laboratories & Supply Chain) to ensure timely notifications and resolutions of discovered potential product and process improvements and/or shortcomings
• Develop, with the Director, Quality & Compliance, departmental expense and headcount projections. Track and manage expenditures and headcount to budget over the fiscal year
• Reviewing and updating employee JD, development plans, ensuring that all employees are properly trained and qualified.
• 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's degree in science or related subject

• Knowledge, Skills and Abilities

• Demonstrated process-driven, analytical, and critical thinking.
• Strong organizational, interpersonal and communication skills.
• Proven ability to lead, manage and motivate subordinates.
• Proven ability to manage multiple, complex 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 6 years of professional related experience in Quality Assurance within a pharmaceutical manufacturing environment and a minimum of 3 years management experience.
• Experience in Pharmaceutical Manufacturing operations, Quality operations, leadership, influencing, and negotiation.

Proven experiences in holding people accountable, developing cross-functional teams, and facilitating decision-making processes

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers 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.