Senior Director / Site Quality Head - Canada

Tevapharm; Basingstoke and Deane; On-site; GBP 80,000 - 101,000; Full time

Benefits offered by this job

Health plan

Employee assistance program

ESPP

Job summary

Teva Canada is seeking a Site Quality Head to lead Quality Assurance, Quality Control, Microbiology, and Quality Systems across multiple sites. You will ensure a robust QMS, enable compliant manufacturing, release, and distribution of products, and act as the highest quality authority on site with independent decision-making.

Travel up to 5% within the United States is noted. The role requires a senior leader with extensive cGMP expertise, strategic mindset, and proven ability to drive CAPA and

Qualifications

• Minimum 10 years of progressive pharmaceutical manufacturing quality leadership experience.
• Extensive knowledge of cGMP requirements and major regulatory authorities.
• Strong understanding of manufacturing, packaging, tech transfer, quality systems, and regulatory compliance.

Responsibilities

• Lead the site's Quality organization including QA, QC, Microbiology, Quality Systems and Quality Compliance.
• Maintain a robust Quality Management System (QMS) and ensure cGMP compliance across sites.
• Prepare for regulatory inspections and support internal/customer inspections.
• Develop and monitor quality KPIs and CAPA effectiveness; manage annual quality budget.

Skills

Quality leadership

Regulatory knowledge

Strategic leadership

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Master's degree (preferred)

Job description

We Are TevaWe’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.Our Team, Your ImpactThe Site Quality Head provides strategic and operational leadership for all Quality functions across Manufacturing, Packaging, Importation, and Laboratory Operations. This role is accountable for fostering a strong quality culture, ensuring compliance with regulatory requirements, and maintaining the highest standards of product quality and patient safety.Key responsibilities include oversight of quality systems and processes, including but not limited to:Development, implementation, and execution of quality procedures and standardsEstablishment Licensing complianceQuality on the Floor activities, audits, and batch disposition/releaseManagement of laboratory investigations, deviations, complaints, and nonconformancesCAPA development, implementation, and effectiveness monitoringQuality metrics, trending, and performance reportingValidation program complianceOversight of equipment, facilities, and utility systems to ensure adherence to established quality requirementsThe role is responsible for leading the development, standardization, implementation, monitoring, and continuous improvement of Quality Systems, compliance programs, industry best practices, and corporate quality initiatives. The successful candidate will drive proactive quality and compliance improvements while strengthening a culture of operational excellence and Good Manufacturing Practice (GMP) compliance.This position also serves as the Senior Person In Charge (SPIC) for Controlled Drug Substances and Narcotics.How You’ll Spend Your DayLead the site's Quality organization, including Quality Assurance, Quality Control, Microbiology, Quality Systems, and Quality Compliance.Ensure a robust and continuously improving Quality Management System (QMS) is maintained.Ensure products are manufactured, released, and distributed in compliance with cGMP requirements and approved regulatory specifications.Serve as the highest-ranking quality authority on site with independent decision-making responsibility regarding product quality and potential market actions.Assess, manage, and mitigate quality risks to ensure products are safe, effective, and compliant before reaching patients.Partner with business leaders to ensure a reliable and compliant supply of products.Develop, implement, and continuously improve the Site Quality Program in collaboration with the Site General Manager and Corporate Quality leadership.Oversee the collection, analysis, and communication of quality data and performance metrics to site leadership, Corporate Quality, and key internal and external stakeholders.Direct Quality Control laboratory operations, including analytical method transfers, testing, and approval or rejection of raw materials, packaging components, in-process materials, and finished products.Champion a sustainable culture of quality by promoting accountability, open communication, continuous improvement, and employee engagement.Build and maintain strong partnerships with the site leadership team and cross-functional stakeholders.Act as a strategic business partner to Supply Chain, Project Management, R&D, Manufacturing Sciences & Technology (MS&T), and Commercial teams to achieve business objectives and project milestones.Provide leadership and expert support during internal audits, customer inspections, and regulatory inspections.Ensure Quality KPIs meet established targets and that CAPA commitments are implemented on time, with effectiveness verified through ongoing monitoring.Develop, manage, and oversee the annual Quality Operations budget while optimizing resources and organizational effectiveness.Provide quality oversight for two pharmaceutical manufacturing sites located in the United States.Travel approximately 5% within the United States.Your Skills and ExperienceCanadian university degree, or a degree recognized as equivalent by a Canadian university, in Chemistry, Chemical Engineering, Biology, Pharmacy, or a closely related life sciences discipline. Preferred: Master's degree or equivalent advanced degree in Chemistry, Biology, Pharmacy, or a related scientific field.Minimum of 10 years of progressive pharmaceutical manufacturing quality leadership experience.Extensive knowledge of cGMP requirements and expectations from major global regulatory authorities, including Health Canada, the U.S. FDA, and the European Medicines Agency (EMA).Strong understanding of pharmaceutical manufacturing, packaging, technology transfer, quality systems, and regulatory compliance requirements.Comprehensive knowledge of Health Canada, FDA, EU, and ICH regulations and guidelines, as well as Chemistry, Manufacturing, and Controls (CMC) content for regulatory submissions.Deep understanding of pharmaceutical production processes, product lifecycle management, equipment qualification, validation programs, and manufacturing technologies.Demonstrated experience leading and preparing for regulatory inspections, including GMP and pre-approval inspections conducted by the FDA and Health Canada.Proven expertise in Quality Systems management and continuous improvement initiatives.Strong leadership track record with experience building, developing, coaching, and inspiring large, high-performing teams.Excellent communication, stakeholder management, and strategic leadership capabilities.How We’ll Take Care of YouAt Teva Canada we provide a rewarding and collaborative work experience, with career growth and development opportunities for employees, in a safe and caring environment! Beyond base pay, Teva also offers a comprehensive suite of wellness and benefits programs tailored to role and employment type, that continue to rank among the best in our industry! Our competitive offerings are designed to provide flexibility, security, and meaningful choices, empowering employees to thrive both personally and professionally throughout their journey with us. As part of our commitment to well-being, employees may have access to:Teva Canada’s choices Benefit Plan including Health, Dental, Disability, Life InsuranceEmployee Assistance Program & Virtual Health ProgramsRetirement Savings ProgramsEmployee Stock Purchase Plan (ESPP)Time for yourself or those you care about, through paid time for Vacation, Wellness days, Care/Sick days, Teva Days and Volunteer DaysEducation Assistance ProgramRecognition programs such as Employee Service AwardsEmployee DiscountsAnd much more!More exciting details on the specific total rewards offerings to be provided at the offer stage depending on the position and employment type hiring for. This position will fill a current vacancy and Teva Canada may use an artificial intelligence (AI) system to assist with the initial screening and evaluation of job applications by analyzing for relevant skills, professional experience, and education, that best match the posted job qualifications. It is important to note that all final decisions in this process are made by a member of the hiring team.Already Working @Teva?Make sure to apply through our internal career site on Twist—your one-stop shop for career developmentTeva’s Equal Employment Opportunity CommitmentTeva 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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.