Quality Assurance Associate II; Scientific

Responsibilities

The Third Party Management Specialist will oversee Third Party Quality operations for the MA Bio Campus, ensuring excellence in quality standards and regulatory compliance across external partnerships. This role requires leading Supplier Change Notification (SCN) processes, managing third party quality event investigations, supporting quality agreement programs including periodic reviews and documentation, and collaborating cross-functionally with QC, Facilities, and Manufacturing departments to resolve compliance issues.

The position reports to the Head of Supplier Governance and requires the ability to gown and enter manufacturing/warehouse areas.

The ideal candidate will have a Bachelor's degree or equivalent experience in Supplier Quality, minimum 6 years of Quality/Operations experience in a biotech/pharmaceutical cGMP manufacturing environment within an FDA-regulated industry, proficiency in Veeva quality management systems, and strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia).

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”