Senior Manager, Quality Assurance

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

We are seeking a highly experienced Senior Manager, Quality Assurance to lead Quality Assurance operations at our Stouffville manufacturing site. This role is responsible for providing leadership, technical expertise, and strategic direction to ensure all Quality Assurance activities are conducted in compliance with SOPs, GMP, and cGMP requirements.

The successful candidate will oversee quality systems, product investigations, product release activities, regulatory compliance, and team development while driving a culture of quality, accountability, and continuous improvement.

• Lead and oversee investigations related to products manufactured at the site, ensuring compliance with regulatory requirements and company standards.
• Ensure investigations are thoroughly documented, maintained, and completed in a timely manner.
• Monitor and track corrective and preventive actions (CAPAs) to ensure effectiveness and compliance.
• Oversee the management and investigation of customer, healthcare professional, and regulatory product complaints.
• Provide expert guidance on quality procedures, SOPs, GMP, and cGMP requirements to Production and Quality teams.
• Maintain current knowledge of FDA and Health Canada regulations governing pharmaceutical manufacturing, packaging, testing, distribution, and quality systems.
• Oversee manufacturing batch record reviews, product release activities, document issuance, and document control processes.
• Act as the Site QA Ecosystem Lead, ensuring the successful implementation and maintenance of quality systems and learning management infrastructure.
• Manage retained sample programs for raw materials and finished products in accordance with regulatory requirements.
• Oversee returned goods processes and ensure only acceptable product is returned to inventory.
• Lead, coach, mentor, and develop Quality Assurance staff through performance management, career development, and succession planning initiatives.
• Participate in and support regulatory inspections and internal audits.
• Promote Environmental Health & Safety (EHS) programs, including hazard identification, incident investigations, root cause analysis, and corrective action implementation.
• Foster a culture of continuous improvement, quality excellence, and regulatory compliance.

• Bachelor's degree in a Science-related discipline required.
• Minimum of 5 years of relevant experience in Quality Assurance within a pharmaceutical, biotechnology, or related regulated manufacturing environment.
• Previous supervisory and people leadership experience required.
• Experience managing quality systems, investigations, audits, and regulatory compliance activities.
• Strong knowledge of SOPs, GMP, and cGMP requirements.
• Familiarity with FDA and Health Canada regulations.
• Experience with Track Wise, Oracle, LIMS, Smart QA, and Microsoft Office applications.
• Understanding of pharmaceutical manufacturing operations, HVAC systems, purified water systems, and statistical analysis.
• Strong leadership, coaching, and team development skills.
• Excellent written and verbal communication skills.
• Proven planning, prioritization, and organizational abilities.
• Strong analytical thinking…