QA Associate Director

Job description

Job Description An amazing opportunity has arisen for an Associate Director, Supplier Quality Assurance (SQA) in our company. This position will be responsible for ensuring the integrity and safety of our products through strategic oversight of global API suppliers. What you will do: Bring energy, knowledge, innovation and leadership to carry out the following: - Serve as the primary Quality liaison for strategic API suppliers, ensuring compliance with GMP, company standards, global regulations, Annex 1 where applicable, 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...