Associate Director, Combination Products

OverviewAssociate Director, Combination ProductsAbout ApotexApotex 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.For more information visit: www.apotex.com.Job SummaryThe Associate Director, Combination Products oversees the quality aspects of products that combine drug, device and/or biological products. This role ensures the safety, efficacy and quality of complex products and ensures compliance with regulatory requirements for combination products and devices, including design control, risk management and the manufacturing process throughout the product lifecycle, from development to post-market surveillance. The incumbent works closely with Apotex, its Contract Manufacturing Organizations, relevant third party suppliers (i.e., Constituent suppliers) and internal stakeholders to ensure compliance.ResponsibilitiesDevelop, implement and maintain quality management systems specific to combination products, ensuring alignment with regulatory requirements and other applicable standards from early phase through commercialization for dosage forms such as sterile pre-filled syringes, pen devices, auto-injectors, topical pumps, nasal delivery devices, inhalation products, and ophthalmics.Maintain and improve quality systems in alignment with combination product requirements under 21 CFR Part 4, QMSR, ISO 13485, and other regulations.Lead or participate in design control activities, risk assessments and development of risk management plans for combination products.Participate on cross-functional teams to bring combination products through the Design Control process to deliver on-time submissions and launches.Review and approve technical protocols, reports and design control documentation.Lead or support investigations into quality issues, including deviations, complaints, and non-conformances related to the combination product, and implement corrective and preventive actions.Represent Apotex during regulatory inspections as the subject matter expert for combination products.Support the audit team as an SME related to combination product and device requirements. Provide support for quality audits and due diligence activities.Lead and manage pre-approval inspection readiness as it relates to combination product inspections.Participate in management reviews to identify and address quality and operational issues related to combination products.Participate in and lead performance conversations with employees, including monthly one-on-ones, to review progress toward objectives, offer support and remove barriers, and communicate performance expectations.Foster open, two-way communication to build trust-based relationships with employees and stakeholders while continuously improving leadership capabilities.Create a culture that values trust and provides opportunities for employee development and growth in pursuit of our purpose and core values—Collaboration, Courage, Perseverance and Passion.Utilize networks to attract and hire talent in a comprehensive, differentiated and consistent manner; onboard new employees with a consistent experience that reflects our values.Ensure adherence of team members with all compliance programs and company policies and procedures.All other duties as assigned.QualificationsEducationB. Sc in a life science10 years of combined experience in Quality Assurance and Operations and/or R&DKnowledge, Skills and AbilitiesStrong knowledge of relevant regulations, quality systems, risk management principles, design control processes, including familiarity with medical device regulations in relevant marketsKnowledge and experience in pharmaceutical processes and equipmentAbility to instill a culture of high performance, accountability, and qualityInterpersonal savvy and relationship management/networking skillsAbility to deal with ambiguity and manage through difficult situationsThorough knowledge of applicable regulatory requirementsExcellent oral and written English communication skillsAbility to analyze and implement process improvementsExperienceExtensive experience in a GMP-regulated environment with specific experience in combination product development, device quality or device developmentDemonstrated track record of successfully building or sustaining combination product compliance systems for pharmaceutical or medical device industryAt Apotex, we are committed to fostering a welcoming and accessible work environment where everyone feels valued, respected, and supported to succeed. We offer accommodations for applicants with disabilities as part of our recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.Seniority levelDirectorEmployment typeContractJob functionProduct Management and MarketingIndustriesPharmaceutical ManufacturingReferrals increase your chances of interviewing at Apotex Corp. by 2xWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr