Manager, Global Quality Systems - TAPI

Manager, Global Quality Systems - TAPI

Teva

Prigorje Brdovecko, Debrecen or Opava

How you’ll spend your day

• Maintain TAPI global QMS documents, continuously improve global procedures and assess and capture changes in regulations;
• Draft, revise, manage distribution, archive, and lifecycle approvals of TAPI Global QMS documents;
• Monitor the effectiveness of the Quality system and prepare reports to executive management as requested;
• Track, trend and report TAPI Quality KPIs;
• Execute strategy for continued compliance and increased efficiency of Quality Management Systems;
• Lead improvements in quality processes across TAPI to advance compliance, efficiency, and customer experience;
• Provide policy overview and prepare global training materials;
• Studium LMS administration for TAPI Global Quality colleagues;
• Perform and drive gap assessments – TAPI standards vs new guidance, TAPI standards vs TAPI site Health Authority observations, TAPI standards vs other firms’ observations (as applicable);
• Track regulatory trends and provide guidance on expected changes that may affect existing and future strategies;
• Track and trend regulatory commitments, creating investigator database;
• Review Health Authority inspection observations and GRA observations and capture requirements in TAPI’s policies and standards;
• Perform and/or assist system owners by performing gap analysis and revisions to existing systems;
• Perform tracking of critical vendor issues, escalate issues to management and collect site assessments, when applicable;
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements;
• Participate and contribute to TAPI Quality forums (e.g. Quality Councils, Quality meeting, etc.).

Your experience and qualifications

• Degree in Pharmaceutical Sciences, Chemistry, Technology, Engineering, Healthcare or an equivalent combination of education and experience for the functional role;
• Minimum of 5 years of experience in the Quality unit in a pharmaceutical company;
• Demonstrated knowledge and working experience with GMP regulations;
• Working knowledge of API manufacturing operations;
• Fluent in written and spoken English;
• Proficient computer skills in current software including MS Office (Excel, PowerPoint and Word);
• Open minded and willing to collaborate with other stakeholders in the organization.

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