Senior Specialist, 3rd Party Quality - EU
Hikma Pharmaceuticals intends to recruit a Sr. Specialist, 3rd Party Quality (m/f) to join the Injectables - Quality Systems department, reporting directly to the Sr. Director, QMS and 3rd Party Quality.
Founded by Samih Darwazah over 40 years ago in Jordan, Hikma aims to provide affordable, quality medicines to people in need. In Portugal, the company has more than 1,000 employees and 3 factories producing injectable medicines.
Main responsibilities
- Lead day-to-day Quality oversight of assigned CMOs and act as the primary Quality contact for routine and escalated matters.
- Review batch release documentation (Certificates of Analysis, Certificates of Conformance, batch records) for compliance with approved specifications and EU GMP, supporting QP certification and market release.
- Monitor release cycle time and other batch release KPIs, escalating delays that put supply at risk.
- Evaluate quality-impacting events and provide documented recommendations for batch disposition decisions.
- Lead the assessment and follow-up of deviations, OOS/OOT investigations, change controls, complaints, CAPAs and temperature excursions for assigned CMOs.
- Review and, where authorized by procedure, approve quality investigations and CAPAs, ensuring sound root cause analysis and effective actions.
- Assess CMO-initiated changes for product quality, registration and supply-continuity impact.
- Lead qualification and periodic requalification of assigned CMOs, including quality risk assessments and recommendations on supplier status.
- Own the Supplier Measurement Scorecard process and apply the CMO tiering framework.
- Analyze monthly and quarterly KPI dashboards, agree improvement actions with CMOs and escalate significant deterioration.
- Conduct or support risk-based CMO audits and coordinate Quality support for regulatory inspections and corporate audits.
- Lead the preparation, negotiation, review and maintenance of Quality Technical Agreements, and keep Approved Supplier List entries aligned with current status.
- Lead Quality review of Annual Product Quality Reviews with CMOs and present data for Quarterly Business Reviews.
- Lead or support recall and Field Alert Report investigations involving CMO-manufactured products, as applicable.
- Partner with Supply Chain, Procurement, Regulatory Affairs, Manufacturing and Quality to align CMO quality, compliance and supply objectives.
- Provide Quality leadership for new CMO onboarding, technology transfers, sourcing decisions and product lifecycle activities.
- Support the Switzerland affiliate Quality Management System under the oversight of the Switzerland Responsible Person, without assuming Responsible Person responsibilities.
- Coach colleagues and share knowledge on third-party quality processes, tools and expectations.
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 escalate significant risks appropriately.
- Strong organizational, stakeholder management, influencing, presentation and technical writing skills.
- Collaborative, 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.
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