Quality Assurance Specialist
We are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our organization, you will play a vital role in ensuring the highest standards of quality and compliance.
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* In this role, you will be responsible for overseeing GxP suppliers and vendors, ensuring that they meet all regulatory requirements.
* You will lead the development, implementation, and continuous improvement of the supplier qualification program.
* This includes risk-based classification, audit planning, and ongoing performance monitoring.
* You will conduct supplier audits, prepare audit reports, track CAPAs, and verify implementation effectiveness.
* Additionally, you will review and approve supplier quality documentation, such as Technical/Quality Agreements, audit responses, change notifications, and deviation reports.
* You will evaluate supplier quality systems and compliance with applicable international regulatory requirements.
* You will provide QA input into procurement decisions and cross-functional sourcing teams to ensure GxP compliance is considered in supplier selection.
* You will support internal stakeholders in supplier-related investigations and risk assessments.
* You will develop and deliver internal training on supplier qualification procedures and regulatory expectations.
* You will represent QA in cross-functional teams involving outsourced activities, ensuring the integrity of GxP-related data and deliverables.
* You will maintain accurate and current records in eQMS systems and supplier management databases.
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Requirements
To succeed in this role, you will need:
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* A Bachelor's degree or higher in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.
* Minimum of 7–10 years of QA experience in the pharmaceutical, biologics, or veterinary vaccine industry.
* At least 5 years of hands-on experience in GxP supplier qualification and auditing, with demonstrated expertise in GMP and at least one of the following: GLP, GCP, GDP.
* Experience with laboratory testing, contract manufacturing, and/or clinical service providers preferred.
* Proficiency in English (written and oral); additional languages are an asset.
* Solid knowledge of EU GMP, FDA regulations, OECD GLP, VICH GCP, and ICH guidelines.
* Proven ability to plan, conduct, and report external audits independently.
* Strong understanding of quality systems, technical agreements, and risk-based approaches to supplier qualification.
* Experience with quality investigations, CAPA management, and change control.
* Proficiency with QMS tools, audit tracking systems, and MS Office; experience with eQMS platforms preferred.
* Critical thinking, strong attention to detail, and ability to interpret complex regulations into operational requirements.
* Excellent communication and interpersonal skills; capable of engaging with diverse stakeholders globally.
* Willingness to travel domestically and internationally up to 25%.
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Benefits
We offer a competitive salary and benefits package, including:
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* The opportunity to work with a diverse team and an established company that offers career progression opportunities.
* They put their people first and live their diversity and inclusion values, embracing all perspectives.
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Additional Information
Please note that we are looking for a candidate with a strong understanding of quality assurance principles and practices, as well as excellent communication and interpersonal skills.