Manager, Site Support
5 days ago
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. For more information visit: www.apotex.com . Job Summary Lead and manage the Manufacturing Documentation Support function for Apotex Operations, ensuring timely, compliant, and high-quality documentation services across Solid and Liquid sites. Job Responsibilities Leadership & Team Management - Recruit, train, and manage team performance. - Conduct regular performance reviews and coaching sessions. - Foster a collaborative and growth-oriented team culture. Documentation & Compliance - Drafting and review of MMaRs, MPaRs, and BPY reports. - Ensure documentation aligns with GxP standards and SOPs. - Act as SME for manufacturing documentation processes. - Initiate change control and timely manner completion - Monitor team workload, resource planning - Drive continuous improvement in the Manufacturing Documentation Support function to enhance service delivery to internal stakeholders. - Deliver timely, data-driven reports (e.g., metrics, resource needs) with clear analysis to support decision-making. - Manage team schedules, approve overtime, and monitor attendance to ensure optimal staffing levels that support business continuity and operational needs - Accurately determine the appropriate change control path, assess potential risks of incorrect decisions, and take corrective actions as needed. - Coach, mentor, and train Technical Writers and relevant stakeholders to ensure change requests are consistently high-quality and compliant with GxP standards - Align corporate and departmental strategies with team and individual performance objectives. - Identify and promote opportunities for process training and cross-training to enhance team capability and personal development. Cross-Functional Collaboration - Represent Manufacturing Support in cross-functional meetings. - Resolve documentation readiness issues and support business initiatives. - Communicate project priorities and updates to stakeholders. Systems & Tools - Utilize SAP, TrackWise, and Microsoft Office applications. - Develop tools to track and report departmental performance. Training & Development - Provide training on documentation systems and templates. - Support cross-training and professional development of team members. Culture & Compliance - Promote a values-driven culture of trust, accountability, and excellence. - Ensure adherence to company policies and compliance programs. - Build trust-based relationships through transparent communication while continuously developing leadership capabilities. - Cultivate a culture of growth and integrity aligned with core valuesIntegrity, Teamwork, Courage, and Innovation. - Leverage professional networks to attract top talent and ensure a consistent, values-driven onboarding experience. All other duties as assigned. Job Requirements Education - Bachelor's/ Master's degree in Science / Pharmacy Knowledge, Skills And Abilities - Should be proficient in MS office tools - Should have excellent verbal & written communication skills - Experience of working on online modules / software would be an added advantage - Well-developed interpersonal and team work skills - Demonstrate leadership and presentation skills. - Working knowledge of a document management system required. - Ability to be flexible and multi-task in a rapidly changing environment. - Ability to complete and coordinate projects with strict deadlines. Experience - Minimum 15 years of experience in the pharmaceutical industry. 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.
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