Head of QA: Audits, Inspections & Supplier Quality

3PBIOVIAN; Noáin; Presencial; EUR 70 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Relocation assistance

Flexible working hours

26 paid days off (vacation + personal)

Resumo da oferta

3PBioViAn is seeking a Head of QA (Audits, Inspections, Suppliers and Plant) to lead the internal audit program, supplier qualification activities, and GMP/compliance initiatives. You will drive audit execution, CAPA, and inspections readiness to support regulatory inspections including FDA inspections.

The role requires advanced English (C1), a Life Sciences degree (Masters desirable), and 3–4 years in QA within pharma/biotech. Located in Navarre, relocation support offered for outside Navarra.

Qualificações

• Bachelor's degree in Biology, Biochemistry, Chemistry, Pharmacy, or related Life Sciences.
• Master's degree in a relevant scientific discipline is highly desirable.
• 3–4 years of experience in Quality Assurance in pharma/biotech/healthcare.
• Strong knowledge of GMP regulations and Quality Management Systems.
• Experience conducting internal audits and supplier qualification activities.
• Exposure to FDA inspections is a strong advantage.
• Advanced English level (C1 or equivalent) required.

Responsabilidades

• Develop and execute internal audit plans aligned with quality and compliance objectives.
• Lead and coordinate internal audits across the organization.
• Design and manage supplier qualification and monitoring programs.
• Execute supplier qualification audits and assessments.
• Monitor and analyze quality KPIs and performance indicators.
• Identify, investigate, and elevate GMP non-conformities when appropriate.
• Lead and support compliance improvement projects.
• Participate in regulatory inspections, customer audits, and mock inspections.
• Contribute to FDA inspection readiness and follow-up activities.
• Collaborate with cross-functional teams to ensure adherence to quality standards and regulatory requirements.
• Support company integration initiatives and quality improvement projects.
• Ensure effective implementation of CAPA.

Conhecimentos

Quality assurance

Internal audits

Regulatory inspections

GMP regulations

English proficiency

Formação académica

Bachelor's degree in Life Sciences

Master's degree desirable

Descrição da oferta de emprego

3PBioViAn is seeking a Head of QA (Audits, Inspections, Suppliers and Plant) to lead the internal audit program, supplier qualification activities, and GMP/compliance initiatives. You will drive audit execution, CAPA, and inspections readiness to support regulatory inspections including FDA inspections.

The role requires advanced English (C1), a Life Sciences degree (Masters desirable), and 3–4 years in QA within pharma/biotech. Located in Navarre, relocation support offered for outside Navarra.