Sr. Specialist, 3rd Party Quality - EU

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

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people in need. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve. At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines.

Hikma intends to recruit an Sr. Specialist, 3rd Party Quality - EU (m/f) to integrate the Injectables - Quality Systems department reporting directly to the Sr. Director, QMS and 3rd Party Quality

Main Responsibilities

• Lead and execute the day-to-day Quality oversight of assigned CMOs and act as the primary Quality contact for routine and escalated matters
• Review and assess batch release documentation, including Certificates of Analysis, Certificates of Conformance and batch records, for compliance with approved specifications and EU GMP, in support of Qualified Person (QP) certification and market release activities.
• Maintain accurate CMO facility, license and Quality Technical Agreement information, and monitor release-cycle performance and supply risks.
• Monitor Release Cycle Time and other batch release KPIs, identifying trends and escalating delays that put supply at risk.
• Evaluate quality-impacting events and provide documented recommendations to support batch disposition decisions
• Lead the assessment and follow-up of deviations, OOS/OOT investigations, change controls, complaints, CAPAs and temperature excursions related to assigned CMOs
• Review and, where authorized by procedure, approve quality investigations and CAPAs, ensuring scientifically sound root cause analysis, appropriate impact assessment and effective actions.
• Assess CMO-initiated changes for product quality, registration and supply-continuity impact, coordinating cross-functional input and escalating significant risks.
• Drive timely closure and verify the effectiveness of corrective and preventive actions
• Lead and execute qualification and periodic requalification activities for assigned CMOs, including quality risk assessments and recommendations on supplier status.
• Own the Supplier Measurement Scorecard process for assigned CMOs and analyze quality, delivery and relationship performance.
• Apply and maintain the CMO tiering framework so that oversight is proportionate to product, compliance and supply-chain risk.
• Analyze monthly and quarterly KPI dashboards, identify adverse trends, agree improvement actions with CMOs and escalating significant deterioration.
• Conduct or support risk-based CMO audits as assigned, document observations, assess CAPA responses and track remediation to closure.
• Coordinate Quality support for regulatory inspections and corporate audits involving assigned CMOs, including readiness activities and follow-up of commitments.
• Lead and perform the preparation, negotiation, periodic review and maintenance of Quality Technical Agreements for assigned CMOs.
• Ensure Approved Supplier List entries remain aligned with current qualification, inspection and sourcing status.
• Lead coordination and Quality review of Annual Product Quality Reviews/Product Quality Reviews with CMOs, ensuring timely completion and follow-up of trends and actions
• Compile, analyze and present quality and performance data for Quarterly Business Reviews, highlighting risks, trends and improvement priorities.
• Lead and support investigations of recalls and Field Alert Reports involving CMO-manufactured products, as applicable.
• Drive continuous improvement of supplier oversight processes, quality metrics, governance tools and ways of working.
• Partner with Supply Chain, Procurement, Regulatory Affairs, Manufacturing and Quality functions to align CMO quality, compliance and supply objectives.
• Provide Quality leadership and subject‑matter expertise for new CMO onboarding, technology transfers, sourcing decisions and product lifecycle activities
• Influence internal and external stakeholders to resolve complex quality issues and protect patient safety, product quality and supply continuity.
• Coach colleagues and share knowledge on third‑party quality processes, tools and expectations.
• Provide and performed defined Quality Management System support, documentation and quality data to the Switzerland affiliate and Responsible Person, as agreed.
• Contribute technical expertise to onboarding, handover and continuous‑improvement activities for the Switzerland affiliate Quality function.
• Perform all affiliate support under the oversight of the Switzerland Responsible Person, without assuming Responsible Person responsibilities.

Profile

• Degree in Pharmacy, Chemistry, Biology, Biotechnology, Microbiology, Engineering, or another relevant scientific discipline.
• Master’s degree in Pharmaceutical Sciences or another relevant field is preferred.
• Recognized auditor training or certification is an advantage.
• 5–8 years of experience in Pharmaceutical Quality Assurance, Supplier Quality, External Manufacturing Quality, Validation, or a comparable GMP environment.
• Experience working with CMOs, quality‑event assessment, supplier performance management, and cross‑functional quality decisions.
• Experience in sterile manufacturing, injectable products, supplier auditing, and regulatory inspections is preferred.
• Strong technical judgment, analytical thinking, and risk‑based decision‑making skills.
• Ability to independently lead complex quality topics, manage competing priorities, and escalating significant risks appropriately.
• Strong organizational, stakeholder management, influencing, presentation, and technical writing skills.
• Collaborative and relationship‑focused approach to external partner management, with the ability to constructively challenge and drive accountability.

We Offer

• Direct contract with Hikma
• Competitive salary aligned with the role
• Life insurance
• Health Insurance extended to student children (up to age 24)
• Annual Performance Bonus
• Real Growth Opportunities

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day