TPM QA Associate Director

About the role

As TPM QA Associate Director, you will manage quality-related activities for a number of Third-Party Manufacturers (TPMs) in the APAC region, including strategic TPMs producing high-volume, biosimilar and sterile products on behalf of Abbott and APO AG. You will also manage APAC geographical activities assigned by management, ensuring safe, efficacious and quality product supply in line with regulatory and business requirements.

Key responsibilities

• Manage quality of Divisional TPMs, including product registration and market launch support, TPM due diligence, onboarding and governance models, and technology transfer quality support.
• Manage Quality System activities, Quality/Technical Agreements, and highly complex TPMs.
• Handle high-impact exception events and CAPAs, review and approve TPM Product Quality Reviews and complaints, and manage quality or regulatory changes.
• Maintain a Quality Management Review program and Quality Performance Measurement process, and support audit and inspection readiness.
• Support Abbott Senior Management through significant event and management review processes, and act as Single Point of Contact for the cross-regional TPM Quality Platform.
• Lead quality activities for new product introduction, support technology transfer projects, and represent the TPM QA group in multi-functional initiatives.
• Manage direct reports and visit TPM locations regularly.

Required profile

• Bachelor's degree or equivalent in a relevant scientific discipline, or industry experience with sufficient exposure to pharmaceutical or related industries.
• Minimum 15 years of experience in QA, QC, Operations or Technical Support within a pharmaceutical environment.
• Auditor or supplier quality management experience in the pharmaceutical industry.
• Experience supervising direct reports and leading teams.

Required skills

• Quality risk management tools and quality systems knowledge.
• Strong data analysis and project management skills.
• Excellent written and verbal communication and cross-cultural collaboration.