Marco Barani Email & Phone Number

Lausanne, Vd, Ch

Supporting biopharma companies in QMS improvement projects, compliance troubleshooting, inspection readiness programs, vendors quality management and risk management.

Basel, Ch

Reporting into the Site Head of Quality, directly managing a team of six professionals and overseeing a network of consultants, accountable to restore the GMP compliance of the facility.

Plan-Les-Ouates, Geneva, Ch

Reporting into the CEO, directly managing two professionals and overseeing a network of consultants. Lead the Quality function overall accountable to ensure GMP/GDP and GCP compliance of clinical studies in EU and US, secure the commercial launch of Yselty® into the EEA market.Reshaped the QMS to smoothly transition the company from development to commercial. Prepared for and passed FDA (BIMO) and EMA GCP inspections to Sponsor site and CROs, as well as GMP inspection from Swissmedic to obtain the first commercial license.Enhanced the Quality oversight of C(D)MO, CRO and contract testing laboratories.

Bad Homburg, Hessen, De

Reporting into the Head of the Business Unit, directly managing five professionals and overseeing a network of consultants. Overall accountability for the GMP/GDP and GCP compliance for the development and commercialization of biosimilars and associated medical devices.Established the QMS for the newly created BU, integrated into the global Fresenius Kabi QMS, including validation of relevant e-QMS (TrackWise, e-DMS) and connected to the Market Units.Prepared for and passed FDA (BIMO) GCP remote review (COVID-19) to Sponsor site and CROs, and Swissmedic GMP/GDP inspection to obtain the first commercial license.Supported several FDA and EMA GMP Pre-Approval Inspections at CMO’s facilities. Contributed to commercial launches of biosimilars in EEA, US, Latin America, and Asia Pacific.

Reporting into the CEO, registered RP, directly managing two professionals and overseeing a network of consultants. Lead the Quality function overall accountable to ensure GMP/GDP and GCP compliance in the development and commercialization of a follitropin alfa biosimilar (combination product).Reshaped the QMS to secure commercial launches in EEA, Canada, Australia, Asia Pacific.Prepared for and passed EMA and Swissmedic GMP/GDP inspections and MHRA Pharmacovigilance inspection.Supported manufacturing Technology Transfers (sterile filling and secondary packaging).Strengthened the Quality oversight of a network of C(D)MOs and 3PLs/distributors.

Plan-Les-Ouates, Geneva, Ch

Reporting into the CEO, directly managing seven professionals. Leading the Quality function overall accountable of the GMP/GDP and GCP compliance for the development and commercialization of various therapeutic products destined to EEA, US, and Asia Pacific.Prepared for and passed GDP inspections (WDA/L) at Market Affiliates in Denmark, Norway and UK.Enhanced the Quality oversight of C(D)MOs and 3PLS/distributors.

Boston, Massachusetts, Us

Reporting into the Executive Director Quality Assurance, registered RP, directly managing three professionals. Overall accountable for the external Quality Operations of commercial activities ex-US.Improved the vendors quality oversight, contributed to Technology Transfers (sterile filling and drug substance) and product launches in EEA, MEA, Japan, Asia Pacific and Latin America in collaboration with Market Affiliates.Prepared for and passed EMA and Swissmedic GMP/GDP inspections.Contributed to GDP inspections (WDA/L) at Market Affiliates in Belgium, France and The Netherlands.

Darmstadt, De

Reporting into the Sr Director Quality Systems Management, Corporate Quality Assurance, directly managing 4 professionals. Overall accountable for designing corporate quality processes, implementing electronic quality management systems (TrackWise, e-DMS), and setting up inspection readiness programs (GMP, GCP, GVP).

Darmstadt, Hessen, De

Reporting into the VP Global Supply Chain, registered RP of Ares Trading SA, directly managing four professionals. Overall accountable for the GMP/GDP compliance and Product Quality over the Supply Chain and Quality liaison with the Market Affiliates.

Darmstadt, Hessen, De

Acting as Qualified Person (QP) of the Clinical Trials Supply Plant, responsible for setting up a Quality Management System to ensure compliance with GMP and GCP of the packaging, control and distribution of Investigational Medicinal Products.

Darmstadt, Hessen, De

Responsible to manage 12 operators, plan, coordinate and control the manufacturing processes respecting Clinical Trials demand

Darmstadt, Hessen, De

Lead the technology transfer of manufacturing, control and distribution of Investigational Medicinal Products from an existing site to a newly built, including the GMP qualification of the Facility, Equipment, Utilities, Processes and Personnel

Darmstadt, Hessen, De

Responsible to develop, optimize and validate DSP and characterization analytical methods of recombinant proteinsLead technology transfers of DSP and QC methods from lab scale, to production

Master Of Science (Msc), Organic Chemistry

Mini Mba, Merck Serono Biopharma Breakthrough Program

Certificate Of Advanced Studies (Cas), Excellence In Healthcare Supply Chain Management