Qa specialist Jobs in Vaughan, ON

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

The Global Director, R&D QA is responsible for the overall leadership and execution of the quality assurance programs and policies across the R&D functions, including the development of R&D Policies and Systems.

Job Responsibilities

• Establish and maintain global policies and standards to support the compliance and business needs of the R&D organizations, consistent with the overall corporate Quality direction
• Quality oversight of all clinical and non-clinical trials conducted in support of submissions for Apotex Inc. and Apobiologix including the evaluation of CROs, Third Party Service Providers and Investigator sites
• Quality oversight and release of stability, submission and bio-batch manufacturing, and testing in support of Apotex regulatory dossiers
• Quality oversight of the auditing of R&D documentation used in support of Apotex regulatory submissions
• Quality management of all 3rd party service providers utilized by the R&D organization to ensure the products meet all applicable regulatory and Apotex quality standards
• Oversight of compliance and quality management of the Global Pharmacovigilance processes and systems
• Proactively identify issues, concerns or any potential or significant risks to the business and if identified, ensure that there are appropriate preventative actions in place
• Actively participate as a member of the Apotex Quality Leadership team, providing input and direction in support of our Global Quality Program
• Champion of all office and corporate policies and procedures
• 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

Knowledge, Skills and Abilities Thorough knowledge of GCP / GLP / GMP / GVP

Exhibited business acumen in understanding cross-functional processes, requirements, relevant information flows, and translating gaps into solutions

Demonstrated strategic, process-driven, analytical and critical thinking

Proficiency in communicating (both orally and in writing) concepts and information at all levels within an organization, particularly at the senior management level

Possession of strong interpersonal savvy and leadership skills as well as a collaborative management style

Proven experience in holding people accountable, developing cross-functional teams and facilitating decision-making processes; previous management experience preferred

Strong proficiency in all MS Office tools

Familiarity with existing corporate database technologies

Ability to handle various priorities in a fast-paced environment

Minimum 10+ years experience in the pharmaceutical industry, 2 years of which has been spent in a laboratory environment and 3 – 5 years in a management role

At Apotex, we are committed to fostering a welcoming andaccessible 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.