Global Director, R&D QA

Join to apply for the Global Director, R&D QA role at Apotex Inc.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.Job SummaryThe 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 ResponsibilitiesEstablish and maintain global policies and standards to support the compliance and business needs of the R&D organizations, consistent with the overall corporate Quality directionQuality 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 sitesQuality oversight and release of stability, submission and bio-batch manufacturing, and testing in support of Apotex regulatory dossiersQuality oversight of the auditing of R&D documentation used in support of Apotex regulatory submissionsQuality management of all 3rd party service providers utilized by the R&D organization to ensure the products meet all applicable regulatory and Apotex quality standardsOversight of compliance and quality management of the Global Pharmacovigilance processes and systemsProactively identify issues, concerns or any potential or significant risks to the business and if identified, ensure that there are appropriate preventative actions in placeActively participate as a member of the Apotex Quality Leadership team, providing input and direction in support of our Global Quality ProgramChampion of all office and corporate policies and proceduresParticipate 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 RequirementsEducationSc. in Chemistry, Biochemistry or a related scienceKnowledge, Skills and AbilitiesThorough knowledge of GCP/GLP/GMP/GVPExhibited business acumen in understanding cross-functional processes, requirements, relevant information flows, and translating gaps into solutionsDemonstrated strategic, process-driven, analytical and critical thinkingProficiency in communicating (both orally and in writing) concepts and information at all levels within an organization, particularly at the senior management levelPossession of strong interpersonal savvy and leadership skills as well as a collaborative management styleProven experience in holding people accountable, developing cross-functional teams and facilitating decision-making processes; previous management experience preferredStrong proficiency in all MS Office toolsFamiliarity with existing corporate database technologiesAbility to handle various priorities in a fast-paced environmentExperienceMinimum 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 roleAt 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.Seniority levelDirectorEmployment typeFull-timeJob functionResearch, Analyst, and Information TechnologyIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Apotex Inc. by 2xGet notified about new Director of Research Development jobs in North York, Ontario, Canada.Scarborough, Ontario, CanadaWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr