Back to jobs
Job Description
How You’ll Spend Your Day
Commercial Quality & Regulatory Oversight
- Provide end‑to‑end quality oversight and regulatory compliance for all Teva products marketed in ANZ
- Approve and manage local third‑party manufacturers and suppliers, ensuring adherence to Teva and regulatory standards
Quality Management System (QMS) Leadership
- Create, maintain, and continuously enhance Standard Operating Procedures (SOPs) and Working Instructions aligned with Teva Corporate Standards and regulatory requirements
- Lead the operational implementation and continuous improvement of the commercial QMS
- Champion a strong quality culture, ensuring ongoing GMP and GDP compliance across commercial operations
- Lead local GMP and GDP training programs
- Oversee Product Quality Reviews (PQRs) where applicable
- Facilitate monthly Quality Council meetings and Quarterly Management Reviews
Market Release & Distribution
- Ensure market release of products from approved suppliers based on batch release documentation and validated transport conditions
- Guarantee full distribution traceability, including product returns
- Ensure GDP compliance across all distribution centres
Complaints, Recalls & Risk Management
- Manage quality complaints, coordinating investigations with manufacturing sites and implementing appropriate CAPAs
- Liaise with Pharmacovigilance where required
- Lead and coordinate product recalls, working closely with regional and global stakeholders including Medical Affairs, Regulatory Affairs, Supply Chain, and EU Qualified Persons
- Escalate critical issues and deliver comprehensive final recall reports
Change Control, Deviations & CAPA
- Administer and continuously improve systems for change control, deviation management, and CAPA processes
Supplier & Third‑Party Management
- Maintain and approve the list of qualified suppliers and service providers
- Ensure Quality Agreements are established, maintained, and up to date with all local partners
Audits & Inspections
- Host and lead GMP/GDP competent authority inspections
- Conduct or coordinate internal audits of the Quality System
- Partner with Corporate Audit teams and lead external audits of warehouses, distributors, and suppliers in line with Teva standards
Stakeholder Engagement & Reporting
- Proactively report critical quality incidents to Quality and local management
- Build strong collaborative relationships with key internal and external stakeholders, including General Management, Regulatory Affairs, Drug Safety, Medical, Supply Chain, global Teva Quality teams, suppliers, and distributors