Key Responsibilities
This position offers the opportunity to shape supplier compliance programs and ensure quality excellence across a global network of partners. As QA Specialist, you will lead supplier qualification and monitoring programs across regulated areas, conduct audits, prepare reports, and oversee corrective actions.
About the Role
* Lead supplier qualification and monitoring programs across GxP areas (GMP, GLP, GCP, GDP)
* Conduct supplier audits (initial, routine, and for-cause), prepare reports, and oversee CAPA effectiveness
* Review and approve supplier quality documentation (agreements, deviations, change controls)
* Assess supplier systems against international standards
* Provide QA support to cross-functional teams and procurement decisions
* Deliver internal training on supplier qualification and compliance expectations
* Represent QA on outsourced projects to safeguard data integrity
* Maintain supplier records in quality systems
Candidate Profile
* Degree in Life Sciences or related field
* 7–10 years' QA experience within pharma, biologics, or vaccines
* Minimum 5 years in supplier qualification & auditing (GMP expertise required; additional GLP/GCP/GDP an advantage)
* Strong knowledge of international regulations and quality systems
* Experienced in audits, CAPA, and change control
* Excellent communication and stakeholder engagement skills
* Fluent English (other languages desirable)
* Willingness to travel internationally