TPM QA Associate Director
Core
Manage quality activities for Third-Party Manufacturers (TPMs) in the APAC region to ensure safe, efficacious, and quality product supply for Abbott's pharmaceutical portfolio.
Role type
Senior IC TPM QA Associate Director
Builds
Safe and compliant pharmaceutical product supply via managed TPMs
Domain
Healthcare / Pharmaceutical Manufacturing / Quality Assurance
Required skills
Pharmaceutical QA management, TPM due diligence and onboarding, Quality System management, Technology transfer quality oversight, CAPA and complaint management, Change control management, Quality metrics and performance measurement, Cross-functional team leadership, Regulatory compliance, Audit readiness, Team management
Preferred skills
None stated
Technologies
Quality Risk Management tools
Responsibilities
Manage quality oversight of Divisional TPMs including sterile, liquid, and solid dosage forms; Lead TPM due diligence, onboarding, and governance model establishment; Manage high-impact exception events and CAPAs; Review and approve TPM Product Quality Reviews and complaints; Manage TPM changes with quality or regulatory impact; Maintain Quality Management Review program and performance measurement processes; Visit TPM locations to maintain expertise and build relationships; Support audit and inspection readiness; Manage direct reports; Act as Single Point of Contact for cross-regional TPM Quality Platform; Support New Product Introduction (NPI) processes.
Seniority
Senior, hands-on IC with management responsibilities
