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Sr. manager, quality & responsible person - switzerland

Genf
Hikma Pharmaceuticals
Inserat online seit: 10 Juni
Beschreibung

Ph3Senior Manager, Quality Responsible Person – Switzerland /h3 pGeneva, Switzerland /p pHikma Pharmaceuticals International /p pAt Hikma, we are driven by our purpose to make quality medicines accessible to patients around the world. We are currently seeking a highly experienced Senior Manager, Quality Responsible Person (RP) to join our Corporate Quality Operations team in Geneva. /p pThis is a critical leadership role with full Responsible Person accountability under Swiss legislation, providing end-to-end quality oversight for our Swiss legal entity and designated third-party manufacturing partners across Europe and the United States. /p h3About the Role /h3 ul liAct as the Responsible Person (RP) in accordance with Article 11 of the Swiss Ordinance on Establishment Licenses /li liOwn and continuously improve the Quality Management System (QMS) for the Swiss entity /li liEnsure full GMP/GDP compliance for import, wholesale distribution, export, and foreign trade activities /li liProvide end-to-end GMP quality oversight of Contract Manufacturing Organizations (CMOs) /li liHold final authority for quality-related decisions to protect patient safety and regulatory compliance /li liLead Swissmedic inspections and manage internal and external audits /li liChampion a Right-First-Time and continuous improvement culture across internal teams and partners /li liLead, mentor, and develop a team of quality professionals /li /ul h3Key Responsibilities /h3 ul liRegulatory and technical oversight of Swiss pharmaceutical activities /li liOversight and governance of third-party quality lifecycle (3P/CMOs) /li liApproval and management of Quality Agreements, change controls, deviations, CAPAs, complaints, recalls, and PQR/APQRs /li liLeadership of internal audits, supplier audits, and authority inspections /li liRisk management in line with ICH Q9 /li liCross-functional collaboration with global Quality, Business Development, and external stakeholders /li /ul h3Qualifications /h3 ul liAdvanced degree in Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, or Biology /li liRecognized qualification as Responsible Person or Qualified Person /li /ul h3Experience Skills /h3 ul liSenior-level Quality experience within the pharmaceutical industry /li liStrong expertise in GMP/GDP, sterile and oral dosage forms preferred /li liProven experience overseeing third-party manufacturers /li liFluent in English and French /li liConfident leader with strong decision-making, communication, and stakeholder management skills /li /ul h3Why Join Hikma? /h3 ul liMake a tangible impact on patient safety and product quality /li liWork within a global pharmaceutical organization with strong values and purpose /li liTake on a high-visibility leadership role within a regulated Swiss environment /li liCollaborate with international teams across Europe, the US, and MENA regions /li /ul pHikma is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. /p /p #J-18808-Ljbffr

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