Senior QA & Qualified Person Manager (GMP/EU)

Barrington James; Vimercate; In loco; EUR 100.000 - 160.000; Tempo pieno

Descrizione del lavoro

Barrington James is seeking a QA Manager in Italy to lead QA activities across GMP-regulated manufacturing and supplier oversight. The role includes acting as QP, coordinating CAPA, audits, and QMS improvements to ensure compliance with Italian and EU standards.

Strong leadership and regulatory liaison skills required. The successful candidate will oversee regulatory submission support, file preparation, and collaboration with Legal and QP teams to ensure quality and product integrity throughout

Competenze

• Bachelor-level or higher degree in a relevant field and regulation-specific qualifications.
• Minimum 10 years' experience in pharma/biopharma QA, with GMP exposure.
• Experience managing QA activities and QA personnel.

Mansioni

• Coordinate and manage QA activities including CAPA, non-conformities, risk management, change control and supplier qualification.
• Audit internal divisions and external partners to ensure GMP/GDP/GVP compliance.
• Prepare and maintain QMS documentation and support regulatory inspections.
• Collaborate with QP and QPPV to ensure pharmacovigilance and QP responsibilities are fulfilled.
• Oversee batch release activities and documentation for medicinal products.

Conoscenze

Quality Assurance

QP responsibilities

GMP

People management

Regulatory compliance

Auditing

Formazione

University degree

Descrizione del lavoro

Barrington James is seeking a QA Manager in Italy to lead QA activities across GMP-regulated manufacturing and supplier oversight. The role includes acting as QP, coordinating CAPA, audits, and QMS improvements to ensure compliance with Italian and EU standards.

Strong leadership and regulatory liaison skills required. The successful candidate will oversee regulatory submission support, file preparation, and collaboration with Legal and QP teams to ensure quality and product integrity throughout