Director Quality Function

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.

The Director of Quality Compliance provides leadership for the site's compliance strategy, Quality Management System (QMS) governance, regulatory inspection readiness programs, and deployment of new quality technologies and digital platforms. The position is responsible for fostering a strong culture of quality, data integrity, risk-based decision making, and compliance excellence while driving sustainable improvements in operational performance and regulatory outcomes. This role leverages advanced data analytics, predictive compliance risk monitoring, Teva Lean Management System (TLMS) principles, and Operational Excellence (OpEx) methodologies to proactively identify, assess, and mitigate quality and compliance risks before they impact regulatory performance, product quality, or patient safety.

This position serves as a strategic enterprise leader responsible for developing, implementing, and advancing Quality Compliance programs that ensure sustained regulatory compliance, inspection readiness, operational excellence, and product quality across the organization.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Manages Regulatory Authority and other external compliance audits (e.g. Third Party audits), including communication and tracking of observations and associated responses.
• Oversees the resolution of issues found during audits/inspections in conjunction with the Quality Assurance, Manufacturing, Packaging, Regulatory Affairs, Supply Chain, etc. functions.
• Oversee the Supplier Qualification program for the site, and external current Good Manufacturing Practice (cGMP) audits for excipient vendors, service providers, and contractors used by the sites. Ensures vendors are re-qualified based on established re-qualification frequencies. Liaises with the Corporate Auditing Group to ensure global vendor audits are performed in a timely manner to meet site vendor qualification requirements.
• Provide strategic oversight of the site Nitrosamines risk management program including risk assessments, control strategies aligned with Teva Global Nitrosamines Strategy and applicable regulations.
• Leads the Inspection Readiness Program for the Davie site.
• As part of Inspection Readiness, assesses the regulatory compliance status of the site with implementation of CAPA to assure compliance. This includes a review of major/critical observations from other Teva sites and pharmaceutical companies, and implementation of site CAPAs, as appropriate.
• Hosts Inspection Readiness meetings with a site cross-functional team to identify and plan remediation activities/projects related to potential compliance issues.
• Evaluates all Critical Quality Global Notifications to Management (GNTM) to determine potential impact to the Davie and Sunrise sites.
• Ensures the filing of Field Alerts and Notification to Management (NTMs) for critical agency reportable events.
• Leads site quality council meetings
• Researches new and developing trends in cGMPs…