Description
A global Pharmaceutical organisation requires a Quality Distribution Manager to join their team based in Switzerland. You will be responsible for the quality oversight of the client`s distribution in the assigned region/countries ensuring compliance with their requirements. You will be keeping all key stakeholders informed of potential product release delays and any local compliance or regulator challenges in the concerned area of responsibility.The Role:
-Ensure appropriate issue escalation occurs related to any quality or compliance issues.
-Manage the 3rd Parties distributors (external or internal to the client) of the assigned region/countries, ensuring compliance to regulatory and requirements.
-Act as the main quality contact partner for 3rd party distributors and liaise between them and all manufacturing sites.
-Write, revise and approve Quality Agreements 3rd party distributors and provide training ensuring adherence to Quality Agreements requirements as well as the client`s requirements.
-Manage review and approve of transportation data and perform on time disposition of vaccine products.
-Manage transport related deviations ensuring root cause analysis is performed and proper remediation actions are defined and timely implemented.
-Participate in compliance audits of 3rd party distributors, as requested.
-Monitoring of 3rd party distributors: Manage risk assessments and ensure proper remediation plan is in place; ensure KPIs reporting; evaluate KPIs trends and escalate negative trends or issue, as appropriate.
-Work with 3rd party Distributors and Global Cold Chain Logistic group to ensure proper cold chain qualification.
Experience/Skills required:
-Graduate in Chemistry, Pharmacy, Microbiology or another related science
-Understanding of GMP/GDP requirements - essential
-Experience of managing transport related deviations
-Extensive experience in Pharmaceutical Industry or a regulated industry, e.g. Pharma production or QA operations, vaccines, biologics
-Key Experience of Coordinating activities between manufacturing sites and 3rd party distributors.
-Collaborating with the different Quality groups within Divisional Quality as well as other relevant stakeholders i.e. Supply Chain, Commercial.
-Experience as a key contact for assigned 3rd parties, manufacturing sites and Divisional QA Organisation regarding status of distributor qualification, shipments, on-going actions with distributors.
Please apply today with a covering letter highlighting your key skills and relevant experience aligned to this contract opportunity.