Director Sterility Assurance and Contamination Controls

Tevapharm; Runcorn; On-site; GBP 120,000 - 180,000; Full time

Job summary

Teva Pharmaceuticals is seeking an experienced leader to drive sterility assurance, microbiology, and contamination control across its global manufacturing network. The role supports inspection readiness, regulatory compliance, and modernization efforts while collaborating with Quality, Operations, R&D, Regulatory Affairs, and Supply Chain teams.

You will act as the primary SME for inspections, lead global policy and lifecycle management, and guide risk assessment and CAPA processes to ensure

Qualifications

• Bachelor's degree in a science-based discipline.
• 15+ years in sterile/aseptic pharmaceutical manufacturing, microbiology, quality assurance, or quality compliance roles.
• Experience leading in matrix and functional environments with technical, operational and people leadership responsibilities.
• Extensive experience supporting health authority inspections, regulatory submissions and lifecycle management.
• Strong knowledge of audit, inspection management, investigations, complaints and CAPA programs.
• Deep aseptic processing expertise including isolators/RABS and Annex 1 requirements.
• Experience with Environmental Monitoring, Contamination Control Strategies, and process simulations.
• Pharmaceutical quality manufacturing in sterile products, biologics, biosimilars, medical devices, or other highly regulated environments.
• Strong understanding of cGMP, quality systems, microbiology, QA, and QC.

Responsibilities

• Define and execute global sterility assurance strategy across sites.
• Own microbiology, CCS, aseptic processing, endotoxin control, sterilization, EM, water systems and governance frameworks.
• Lead policy, standards and lifecycle management; oversee modernization and digitalization.
• Serve as SME for inspections (FDA, EMA, MHRA) and regulatory responses.
• Provide technical support to R&D programs, validation strategies and regulatory submissions.
• Chair sterility assurance councils and cross-functional networks.
• Manage risk assessments, mitigation strategies and contamination investigations.
• Ensure compliance with Teva's global standards and cGMP requirements.
• Support Quality Compliance initiatives and Teva's Long Range Plan.
• Contribute to Quality Risk Management and global regulatory guidance.

Skills

Sterility assurance

Microbiology

Quality compliance

Regulatory inspections

cGMP knowledge

Auditing & investigations

Cross-functional leadership

Technical writing

Education

Bachelor's degree in Chemistry, Microbiology, Pharmacy, Engineering, or another science-based discipline

Job description

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.

How You’ll Spend Your Day

We are looking for an experienced quality and compliance leader with deep expertise in sterility assurance, microbiology, and contamination control to join our Global Quality organization. In this highly visible global role, you will drive quality, compliance, and operational excellence across Teva's manufacturing network and external partners, supporting inspection readiness, regulatory compliance, modernization initiatives, and contamination prevention strategies. Working closely with Quality, Operations, R&D, Regulatory Affairs, Supply Chain, and Technical Operations teams, you will play a key role in advancing Teva's commitment to product quality and patient safety.

Travel Requirements: Up to 30% domestic and international travel.

• Define and execute the global sterility assurance (SA) strategy across internal sites and CMOs.
• Own aspects of the global microbiology, CCS, aseptic processing, endotoxin control, sterilization, EM, water systems, and CCI governance frameworks.
• Lead global policy, standards, and procedural lifecycle management.
• Oversee modernization, harmonization, and digitalization efforts.
• Serve as primary SME for inspections (FDA, EMA, MHRA), readiness activities, and regulatory responses.
• Provide technical support to R&D programs, validation strategies, and regulatory submissions.
• Chair cross-functional sterility assurance councils and technical networks.
• Manage global risk assessments, mitigation strategies, and contamination/event investigations.
• Provide guidance to ensure compliance with Teva's global standards, regulatory guidelines, and cGMP requirements.
• Support/lead Global Quality Compliance Initiatives and contribute to Teva's Long Range Plan.
• Support critical product incident management events, including complex investigations and CAPA development.
• When needed, work collaboratively with the site compliance teams to perform walkthroughs and maturity assessments.
• Work with sites to ensure mock audits support a strong state of inspection readiness.
• When needed, write or execute protocol for deep dive quality compliance assessments and risk assessments.
• Help create, review and monitor the Quality Improvement Plans (QIP) to minimize compliance risk and improve quality performance.
• Ensure Quality Risk Management is implemented effectively to assess, control, communicate, and review risks.
• Contribute to Teva's Global Compliance Network through GxP interpretation, knowledge sharing, and regulatory guidance.

Your Skills and Experience

Do you have?

• Bachelor's degree in Chemistry, Microbiology, Pharmacy, Engineering, or another science-based discipline.
• 15+ years of experience in sterile/aseptic pharmaceutical manufacturing, microbiology, quality assurance, or quality compliance roles.
• Experience leading in both matrix and functional environments with technical, operational, and people leadership responsibilities.
• Extensive experience supporting health authority inspections, regulatory submissions, approvals, and lifecycle management.
• Strong knowledge of audit and inspection management, investigations, complaints, and CAPA programs.
• Deep aseptic processing expertise, including knowledge of isolators/RABS and Annex 1 requirements.
• Experience supporting Environmental Monitoring (EM), Contamination Control Strategies (CCS), and process simulations.
• Pharmaceutical quality manufacturing experience within sterile products, biologics, biosimilars, medical devices, or other highly regulated environments.
• Strong understanding of cGMP requirements, quality systems, microbiology, quality control, quality assurance, and quality compliance.
• Deep knowledge and experience in auditing, compliance, and quality oversight.

Are You?

• A recognized subject matter expert who can influence across a global organization.
• A strong problem solver with excellent analytical and technical writing skills.
• An effective communicator with strong presentation, collaboration, and negotiation skills.
• Comfortable operating in a complex, global matrix environment.
• Skilled in project management, prioritization, and change leadership.
• Proactive, self-motivated, and committed to continuous improvement.
• Able to navigate changing priorities while building strong partnerships across functions and cultures.

How We’ll Take Care of You

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community. When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way.

Teva’s Equal Employment Opportunity Commitment

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. 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.