Serve as the primary Quality liaison for strategic API suppliers, ensuring compliance with GMP, company standards, global regulations, and the company Quality Manual
Maintain and negotiate Quality Agreements; assess supplier capability using risk-based tools; plan and lead audits; and drive effective CAPA with verification of effectiveness
Strengthen supplier Quality Management Systems by overseeing change control, deviations, CAPA, OOS/OOT, document control, training, internal audits, and management review
Lead investigations into deviations, OOS/OOT, microbiological excursions, stability issues, and complaints; ensure robust root-cause analysis, remediation, and required regulatory reporting
Provide oversight for technology transfers and process validation; drive inspection readiness; represent the company during regulatory interactions and inspections
Monitor supplier performance, collaborate with cross-functional partners, escalate critical risks, and coach internal and supplier teams in a global, matrixed environment

Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Chemical Engineering, or a related scientific/engineering field
8+ years of experience in GMP-regulated environments (API and/or drug product)
Strong working knowledge of EU, FDA, and relevant global regulations
Familiarity in ICH guidelines and Annex 1 where applicable
Hands-on experience with QMS elements including change control, deviations, CAPA, OOS/OOT investigations, document control, training, internal audits, and management review
Ability to lead root-cause analysis and remediation for deviations, OOS/OOT, microbiological excursions, stability issues, and complaints
Fluent in English with the ability to communicate clearly in a global, virtual environment
Strong interpersonal, negotiation, and influencing skills

QA Associate Director

Key skills