We are seeking an experienced Quality Assurance Specialist / Auditor to focus primarily on Quality Technical Agreements (QTAs) and GMP audits across suppliers, CMOs, and partners. The role will ensure agreements are maintained, audits are planned and followed up effectively, and key compliance risks are managed in line with EU GMP and internal quality requirements.

Key Responsibilities

Quality Technical Agreements (QTA): Draft, review, negotiate, implement, and maintain QTAs with suppliers, CMOs, and partners, ensuring clear GMP responsibilities and compliance expectations.
Audits: Plan, conduct, report, and follow up GMP audits of suppliers, CMOs, and service providers, including tracking observations through timely closure.
Supplier/CMO oversight: Support supplier qualification, risk assessment, documentation review, and ongoing performance monitoring.
QMS, documents, and EU guidance: Review and approve key quality documents, contribute to QMS activities as needed, and assess relevant EU GMP/EMA guideline updates for compliance impact.
Cross-functional collaboration: Work with internal teams and affiliates to support quality and compliance objectives.

Qualifications

Strong Quality Assurance and Quality Management skills, including experience implementing and maintaining pharmaceutical quality systems.
In-depth understanding of Good Manufacturing Practice (GMP) and EU regulatory guidelines relevant to medicinal products.
Experience in Quality Auditing, including participation in or execution of internal and external audits.
Bachelor’s degree (or equivalent) in Pharmacy, Chemistry, Life Sciences, or a related discipline; advanced qualifications are an asset.
At least 5 years of experience in a GMP-regulated pharmaceutical environment, ideally within EU regulation.
Strong analytical, problem-solving, and documentation skills, with attention to detail and a structured approach to quality-related tasks.
Effective communication, negotiation and teamwork abilities, with proficiency in English.

EU Quality Assurance Specialist & Auditor

Job Description