Director, Quality Assurance Jobs

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Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

The Director, Quality Assurance is responsible to oversee and manage adherence to global quality and compliance systems, associated standards, and regulations at all three sites of Teva Canada’s Manufacturing and Packaging operations. The individual will act as liaison with Teva peers in the global quality and compliance organization, cross-functional peers in the Canadian organization to develop strategies and champion all areas of quality governance and oversight in alignment with operational, business initiatives. As a member of the Senior Leadership team, the individual will be responsible for contributing and adhering to the organization’s quality strategy to achieve the best customer service standards; employing continuous improvement strategies and integrity; while collaborating with other functional areas to nurture a strong quality culture and continue to evolve an excellent quality program across the business.

Key Duties & Responsibilities

• Manage the review and implementation of Quality Improvement/enhancement and compliance risk remediation plans identified through Corporate, internal GMP/GXP audits, regulatory inspections and customer audits
• Ensure adherence to safety, ethical compliance standards of Teva at all times
• Collaborate with local, segment, global operational and supply chain groups to foster a proactive approach to compliance
• Support other cross-functional areas of business to mitigate any risks to the QMS
• Provide quality expertise and lead the Quality Assurance activities for Teva Canada and is directly responsible for the quality and cGMP compliance of the sites in partnership with the site operational leadership team
• Manage Quality team of professional(s) including performance management, succession planning (coach and develop employees) and workload
• Act as primary responsible person overseeing all QA related tasks and ensuring that a quality management system (QMS) is implemented and maintained, in line with Teva’s Quality and cGMP/GXP requirements, including but not limited to; Investigations (Deviations, Complaints, Laboratory Investigations) Management; Corrective Action and Preventative Actions; Validation and Qualification records; EBR and Inspection plans in ERP; Independent quality oversight of Quality Control Laboratory Operations; Periodic trend reports; Electronic Data Review and audit trail; QA IT systems validation; Quality Risk Management Program; Change Control evaluations and task implementation; Raw material and Packaging vendors qualification and performance Management; Inspection Readiness initiatives; Sampling; Market Actions; Quality Technical Agreements; Quality Council Meetings; New product launches; Records management Bulk and Finished product lots release of local manufactured products by Teva Canada in compliance with cGMP requirements
• Act as lead for preparation, coordination and management of domestic (Health Canada), international (USFDA, MHRA) and client GMP inspections including inspection response management and quality alert queries
• Ensure that Teva’s Policies, Global Quality Standards, site Operating Procedures (SOPs) and new or transpiring regulatory changes are rolled out and implemented in accordance with local GMP/GXP guidelines at the site level
• Responsible for monitoring and measuring all quality, operational and toolbox KPIs and business initiatives associated with quality operations at the sites

Qualifications

• Excellent leadership, communication (written and spoken) skills, influencing skills, ability to navigate across the organization and build high-performing teams and strong cross-functional stakeholder relationships
• Willingness to travel across Teva Canada facilities on a routine basis and international travel on as needed basis
• 10+years of practical and progressive experience in pharmaceutical Quality Operations [manufacturing operations and controls, laboratory operations, and quality systems] within a cGMP environment of large site and/or multi-site facilities
• Navigate through automated systems (i.e., ERP, LIMS, TrackWise, etc.)
• Hold a minimum Bachelors university degree in Science, Engineering, Technical discipline, or a related field recognized as equivalent by a Canadian university or Canadian accreditation body in a science related to the work being carried out
• With 4+years in a leadership position with direct supervision of each working shift during which activities under their control are being conducted
• Have a strong grasp of current industry trends, apply critical and strategic thinking, interaction with regulatory professionals, knowledge of international regulatory standards, and expectations to be able to adopt best practices

Sub Function

Manufacturing Quality Assurance

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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.