Marco Barani

Marco Barani Email and Phone Number

Pharma & Biopharma Quality Professional @ Supply Chain Operations SA
Lausanne, VD, CH
Marco Barani's Location
Vevey, Vaud, Switzerland, Switzerland
Marco Barani's Contact Details

Marco Barani work email

Marco Barani personal email

About Marco Barani

Accomplished Pharma and Biopharma Quality and Compliance professional within Research, Development, Manufacturing, Control, Supply Chain and Surveillance.Possess a proven track record of success in setting and achieving goals by transforming multi-cultural organizations, implementing effective strategies, executing robust operations, and managing high performing teams. Recognized Qualified Person with extensive experience in Quality Management within GMP, GDP, GCP, GVP. Knowledge of Medical Devices regulations and combination products.Effectively manages Regulator expectations including the FDA, EMA, Swissmedic and ICH benefiting from the strong knowledge of International Quality Standards. Talented communicator with the ability to foster collaborative relationships both internally and externally.Experienced in developing, implementing, and monitoring Quality Plans aligned with the Company global strategy. Passionate about Quality Management Systems, Compliance Troubleshooting, Suppliers Quality, Risk and Inspection Management.Interested in new projects in the pharma, biopharma and medical device industries.Specialties: GMP | GDP | GCP | GVP | ICH | Product Quality | Quality Management Systems | Quality Compliance | Quality Operations | Qualified Person | Lead Auditor | Quality Risk Management | Suppliers Quality | Inspection Management (FDA | EMA | Swissmedic | other countries) | Trainer in GxP | Development | Manufacturing | Control | Laboratory | Supply Chain | Distribution | Pharmacovigilance | Biologics | Solid Oral Dosage | Injectables | Combination Products | Medical Devices | Biosimilars | Regulatory Submissions (IND, BLA, MA, RtQ) | Technology Transfer | CDMO Oversight | Computerized Systems | Change Control | Deviation Management | CAPA | Batch Release | Performance Metrics | People Management | Stakeholder Management | New Markets | Remediation | Re-engineering | Re-organization | Multilingual Communication | Intercultural and International Environment

Marco Barani's Current Company Details
Supply Chain Operations SA

Supply Chain Operations Sa

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Pharma & Biopharma Quality Professional
Lausanne, VD, CH
Website:
supplychainoperations.ch
Employees:
16
Marco Barani Work Experience Details
  • Supply Chain Operations Sa
    Supply Chain Operations Sa
    Lausanne, Vd, Ch
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  • _
    Senior Quality Consultant
    _ Jan 2024 - Present
    Supporting biopharma companies in QMS improvement projects, compliance troubleshooting, inspection readiness programs, vendors quality management and risk management.
  • Lonza
    Head Of Qms And Compliance At Bioatrium Ag
    Lonza Sep 2023 - Dec 2023
    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.
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  • Obseva Sa
    Head Of Quality
    Obseva Sa Sep 2021 - Sep 2023
    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.
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  • Fresenius Kabi
    Senior Director Quality Operations
    Fresenius Kabi Mar 2018 - Aug 2021
    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.
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  • Finox Biotech Ag
    Head Of Quality
    Finox Biotech Ag Feb 2015 - Feb 2018
    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.
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  • Stragen Pharma Sa
    Head Of Quality
    Stragen Pharma Sa May 2014 - Jan 2015
    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.
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  • Alexion Pharmaceuticals
    Senior Quality Manager
    Alexion Pharmaceuticals Oct 2009 - Mar 2014
    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.
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  • Merck Kgaa
    Associate Director, Corporate Quality Systems Management
    Merck Kgaa Nov 2007 - Oct 2009
    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).
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  • Merck Serono
    Manager, Quality Assurance
    Merck Serono Jul 2001 - Oct 2007
    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.
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  • Merck Serono
    Manager, Qa/Gmp Compliance
    Merck Serono Jan 1999 - Jun 2001
    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.
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  • Merck Serono
    Manager, Production
    Merck Serono Jul 1997 - Dec 1998
    Darmstadt, Hessen, De
    Responsible to manage 12 operators, plan, coordinate and control the manufacturing processes respecting Clinical Trials demand
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  • Merck Serono
    Manager, Technical Transfer
    Merck Serono Feb 1997 - Jun 1997
    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
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  • Merck Serono
    Specialist, Biotechnology Processes And Analytics
    Merck Serono May 1994 - Jan 1997
    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
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Marco Barani Skills

Gmp Pharmaceutical Industry Validation Gxp Quality System Biotechnology Quality Assurance Technology Transfer Biopharmaceuticals Fda 21 Cfr Part 11 Quality Management Capa R&d Regulatory Affairs Quality Control Cleaning Validation Change Control Pharmaceutics Lims Hplc Medical Devices Contract Manufacturing Computer System Validation Regulatory Submissions Glp Aseptic Processing Gcp V&v

Marco Barani Education Details

  • Sapienza Università Di Roma
    Sapienza Università Di Roma
    Organic Chemistry
  • London Business School
    London Business School
    Merck Serono Biopharma Breakthrough Program
  • Epfl
    Epfl
    Excellence In Healthcare Supply Chain Management

Frequently Asked Questions about Marco Barani

What company does Marco Barani work for?

Marco Barani works for Supply Chain Operations Sa

What is Marco Barani's role at the current company?

Marco Barani's current role is Pharma & Biopharma Quality Professional.

What is Marco Barani's email address?

Marco Barani's email address is ma****@****ail.com

What schools did Marco Barani attend?

Marco Barani attended Sapienza Università Di Roma, London Business School, Epfl.

What skills is Marco Barani known for?

Marco Barani has skills like Gmp, Pharmaceutical Industry, Validation, Gxp, Quality System, Biotechnology, Quality Assurance, Technology Transfer, Biopharmaceuticals, Fda, 21 Cfr Part 11, Quality Management.

Who are Marco Barani's colleagues?

Marco Barani's colleagues are Maria Luz Monterrubio, Tim Foetisch, Arturo Javier, Laurent Foetisch, Armand Villadoniga, Yves Guisolan, Christophe Wadowski.

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