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 escalate 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…