EU Senior 3rd-Party Quality Lead

Hikma Pharmaceuticals; Sintra; On-site; EUR 70,000 - 110,000; Full time

Benefits offered by this job

Direct contract with Hikma

Health Insurance extended to student/С

Annual Performance Bonus

Life Insurance

Growth Opportunities

Job summary

Hikma Pharmaceuticals in Portugal is seeking a Sr. Specialist, 3rd Party Quality for the Injectables - Quality Systems team. You will oversee CMOs, support QMS processes, and ensure EU GMP compliance for batch release and QP certification.

You will drive CAPAs, investigations, supplier assessments, and KPI tracking, partnering with Regulatory Affairs, Manufacturing, and Supply Chain to protect patient safety and supply continuity.

Qualifications

• Degree in Pharmacy or a related scientific field.
• Master’s degree preferred in Pharmaceutical Sciences or similar.
• Auditor training or certification is an advantage.

Responsibilities

• Lead day-to-day Quality oversight of assigned CMOs and act as primary Quality contact for routine and escalated matters.
• Review batch release documentation for compliance with EU GMP and approved specifications.
• Maintain CMO facility, license and Quality Technical Agreement information and monitor release-cycle performance.
• Monitor Release Cycle Time and KPI trends, escalating delays affecting supply.
• Lead deviations, OOS/OOT investigations, change controls, CAPAs and temperature excursions.
• Lead qualification and requalification activities for CMOs, including QA risk assessments.

Skills

Quality oversight

GMP knowledge

Risk assessment

CAPA management

Supplier management

Audit coordination

Cross-functional teamwork

Education

Degree in Pharmacy

Master’s in Pharmaceutical Sciences

Auditor certification

Job description

Hikma Pharmaceuticals in Portugal is seeking a Sr. Specialist, 3rd Party Quality for the Injectables - Quality Systems team. You will oversee CMOs, support QMS processes, and ensure EU GMP compliance for batch release and QP certification.

You will drive CAPAs, investigations, supplier assessments, and KPI tracking, partnering with Regulatory Affairs, Manufacturing, and Supply Chain to protect patient safety and supply continuity.