Director Sterility Assurance and Contamination Controls

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.

Key Responsibilities 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…