Responsibilities
- Lead and manage the site’s internal, external, and supplier audit programs, ensuring compliance with GMP regulations, corporate quality standards, and applicable health authority requirements.
- Develop, coordinate, and monitor the annual audit plan, including the organization of cross‑functional audit teams and follow‑up of corrective and preventive actions (CAPAs).
- Drive continuous improvement initiatives by assessing compliance with cGMP requirements, identifying risks and improvement opportunities, and partnering with functional teams to implement corrective actions.
- Ensure audit readiness across the site by maintaining effective audit systems, procedures, and inspection preparedness programs.
- Conduct supplier and third‑party audits as part of qualification and approval processes, ensuring vendors meet GMP requirements, quality agreements, and company expectations.
- Prepare, maintain, and update audit‑related procedures in alignment with corporate quality policies and global regulatory requirements.
- Support Regulatory Affairs and regional quality teams by providing audit documentation, supplier compliance data, and quality‑related information for product registrations and regulatory requests.
- Monitor and report quality compliance metrics and KPIs while supporting a culture of quality, compliance, and continuous improvement throughout the organization.
Qualifications
- Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, Engineering, or another relevant scientific or technical discipline.
- 3‑5 years of experience in the pharmaceutical industry or other regulated manufacturing environments.
- Experience in Quality Assurance, Quality Control, Manufacturing, or Quality Systems, including process controls and documentation management.
- Strong knowledge of GMP/cGMP requirements and pharmaceutical quality systems.
- Understanding of pharmaceutical regulations and health authority requirements, including ANMAT and international regulatory standards.
- Experience performing audits, assessing compliance risks, and managing CAPA activities.
- Strong analytical, organizational, and problem‑solving skills with attention to detail.
- Effective communication and stakeholder management skills, with the ability to work across multiple functions.
- Proficiency in SAP, Microsoft Office applications and quality documentation systems.
- Intermediate to advanced English proficiency.
Preferred Qualifications
- Experience conducting supplier, contract manufacturer, or third‑party audits.
- Knowledge of global pharmaceutical regulations and inspection practices from international health authorities.
- Familiarity with supplier qualification programs, quality agreements, and vendor management processes.
- Experience supporting regulatory inspections, submissions, and audit readiness initiatives.
- Understanding of Environment, Health & Safety (EHS) requirements within a manufacturing environment.
- Lead Auditor certification or formal audit training.
- Proven ability to influence cross‑functional stakeholders and drive continuous improvement projects.
- Experience working in multinational pharmaceutical organizations and global quality compliance programs.
Benefits
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, including 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. For career development, Twist, our one‑stop shop for growth, offers a wide range of learning programs, short‑term projects, and internal opportunities to help you shape your path.
Teva Pharmaceuticals is committed to equal opportunity in employment. We provide equal employment opportunity 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. If you require accommodations during the recruitment or selection process, please let us know; all accommodation information will be treated as confidential and used solely to provide an accessible candidate experience.