QA Specialist - GxP Supplier and Vendor Oversight
About The Company
Join a leading global organization in the pharmaceutical and biologics industry, dedicated to innovation and excellence in vaccine development.
The Work
As a QA Specialist, you will play a critical role in ensuring the quality and compliance of GxP-relevant suppliers. Your responsibilities will include:
- Leading the qualification and oversight of suppliers, focusing on GMP, GLP, GCP, GDP compliance.
- Developing and enhancing the supplier qualification program with risk-based classification and audit planning.
- Conducting supplier audits, preparing reports, and managing CAPAs.
- Reviewing and approving supplier quality documentation and ensuring compliance with international regulations.
- Providing QA input into procurement decisions and supporting cross-functional sourcing teams.
- Delivering internal training on supplier qualification procedures and regulatory expectations.
- Representing QA in cross-functional teams to ensure integrity of GxP-related data.
- Maintaining records in eQMS systems and supplier management databases.
The Person
We are looking for a candidate with:
- A Bachelor’s degree or higher in Life Sciences, Pharmacy, Biotechnology, or related field.
- 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry.
- 5 years of experience in GxP supplier qualification and auditing, with expertise in GMP.
- Knowledge in laboratory testing, contract manufacturing, or clinical service providers is preferred.
- Proficiency in English; additional languages are a plus.
- Strong knowledge of EU GMP, FDA regulations, and ICH guidelines.
- Excellent communication skills and ability to engage with global stakeholders.
- Willingness to travel up to 25% domestically and internationally.
The Benefits
We offer a comprehensive benefits package, including:
- Opportunities for professional development and training.
- Health and wellbeing programs.
- Flexible work policies.
- A collaborative team environment.
- Recognition programs and potential for career advancement.
Diversity & Inclusion Statement
We are committed to fostering a diverse and inclusive workplace. We welcome applications from candidates of all backgrounds and experiences, ensuring equal opportunity for all.