Animal Health, Assoc. Dir, Quality Assurance

539

Hybrid
Supplier quality assurance
Gmp compliance
Global regulations
This job posting is for an Associate Director of Supplier Quality Assurance at a biopharmaceutical company focused on innovative health solutions for both humans and animals. The position involves ensuring compliance and quality oversight of global API suppliers, requiring substantial experience in GMP environments and regulatory knowledge

Job Summary

  • Serve as the primary Quality liaison for strategic API suppliers, ensuring sustained compliance with GMP, company standards, global regulations (EU, FDA, others), Annex 1 where applicable, and the our company Quality Manual.
  • Lead investigations into deviations, OOS/OOT, microbiological excursions, stability issues, and complaints; ensure robust root-cause analysis, remediation, and required regulatory reporting.
  • Collaborate with Technical, Regulatory, Procurement/Supply Chain, and manufacturing sites to ensure alignment, timely issue resolution, and risk management.

Matching Summary

Match Score: 85

This job posting is for an Associate Director of Supplier Quality Assurance at a biopharmaceutical company focused on innovative health solutions for both humans and animals. The position involves ensuring compliance and quality oversight of global API suppliers, requiring substantial experience in GMP environments and regulatory knowledge.

Skills & Requirements

Must-have

  • Supplier Quality Assurance
  • GMP compliance
  • global regulations
  • Quality Agreements
  • risk-based tools
  • on-site/remote audits
  • CAPA
  • QMS elements
  • regulatory impact assessments
  • root-cause analysis
  • technology transfers
  • process validation
  • inspection readiness
  • supplier performance monitoring
  • cross-functional collaboration
  • critical quality risks
  • quality culture
  • global, virtual, matrixed environment

Nice-to-have

  • formal auditor training
  • quality certifications
  • sterile manufacturing
  • biologics experience
  • combination products experience
  • regulatory inspections experience
  • electronic QMS/LIMS/TrackWise proficiency
  • Excel and data analysis skills
  • continuous improvement

Key Requirements

  • Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or a related scientific/engineering field
  • 8+ years in GMP-regulated environments
  • Proven responsibility in Quality Assurance/Quality Control and manufacturing/technical operations
  • Strong working knowledge of EU, FDA, and relevant global regulations
  • Familiar with ICH guidelines and Annex 1
  • Hands-on experience with QMS elements
  • Ability to lead root‑cause analysis and remediation
  • Fluency in Japanese and strong proficiency in English
  • Strong interpersonal, negotiation, and influencing skills
  • Able to work independently with limited supervision
  • Willing and able to travel ~25% domestically and internationally

Work Rights

Not specified

Tailored Resume

Cover Letter