Senior Quality & QP Manager — GMP, QMS & Inspections

Barrington James; Vimercate; On-site; EUR 90,000 - 130,000; Full time

Job summary

Barrington James is seeking a QA Manager to lead QA activities at the manufacturing site in accordance with GMP, GDP and GVP requirements. The role includes acting as Quality Representative and performing QP duties under Italian regulations.

The candidate should have extensive experience in QA within GMP-regulated manufacturing or CDMO environments and be capable of coordinating CAPA, audits, and QMS improvements, while supporting regulatory submissions and inspections.

Qualifications

• Leadership experience in QA within pharmaceutical manufacturing.
• Extensive knowledge of GMP/GDP/GVP requirements.

Responsibilities

• Coordinate QA activities including CAPA, non-conformities, change control, validation, supplier qualification and auditing.
• Prepare and manage QMS documentation and site Master File (SMF).
• Collaborate with QP for pharmacovigilance, inspections, and regulatory submissions.
• Ensure batch release compliance and regulatory document preparation for modules of submissions.
• Lead QA training and coordinate with Regulatory Authorities for inspections.

Skills

QA management

GMP compliance

QP responsibilities

Internal audits

CAPA and RCA

Job description

Barrington James is seeking a QA Manager to lead QA activities at the manufacturing site in accordance with GMP, GDP and GVP requirements. The role includes acting as Quality Representative and performing QP duties under Italian regulations.

The candidate should have extensive experience in QA within GMP-regulated manufacturing or CDMO environments and be capable of coordinating CAPA, audits, and QMS improvements, while supporting regulatory submissions and inspections.