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Work Background
Kisco Pharma Outsourcing SolutionsIndependent Quality & Regulatory Compliance Expert
Feb. 2025Basel, Switzerland• Oversee quality compliance support for manufacturing transfer to a CMO, ensuring adherence to US market regulations. • Develop and implement a compliance strategy to meet supplier business demands, enhancing product release efficiency. • Collaborate with management to streamline processes and improve overall quality control measures.
B SquaredIndependent Quality Compliance Consultant (Senior Quality Leader & Compliance Expert)
Jan. 2025Basel, SwitzerlandIn collaboration with B Squared Sarl, I offer quality and regulatory compliance expertise for biotechnology, cell and gene therapy, and medical device industries. I support clients to ensure their quality compliance objectives have tailored remedial solutions in support of fast-paced business goals requirements.
Seeking new opportunity, available for consulting engagementsGlobal Quality Compliance Professional & Certified Auditor
Nov. 2023
Sobi - Swedish Orphan Biovitrum AB (publ)GXP Audit Team Lead
Sep. 2022 - Dec. 2023Basel, Switzerland
BeiGeneDirector - Head IMP Quality Europe
Dec. 2021 - Jul. 2022Basel, Switzerland
BeiGeneSenior Manager, GMP Quality, Europe
Feb. 2020 - Feb. 2022Basel Area, Switzerland
Altran Life SciencesSenior Consultant - Client Project Manager
Apr. 2019 - Jan. 2020Basel Area, Switzerland
RocheGlobal GMP Compliance Auditor
Jul. 2015 - Apr. 2019PTQG Audits
Novartis Vaccine & DiagnosticsGMP Compliance Manager
Mar. 2011 - Jun. 2015
SYGR EnterprisesFreelance Consultant
Jan. 2009 - Mar. 2011
SPECTRA Medical Devices, Inc.Quality & Regulatory Director
Jan. 2007 - Dec. 2008Global change management improvement project (US, South Korea, Europe) to raise the operational management standard of the company to comply with EC and US-FDA regulations and with ISO13485:2003 manufacturing standards certification.
ParexelProject Manager
Jan. 2000 - Dec. 2007Provided project management, Quality Systems structure, compliance auditing/remediation solutions and manufacturing systems validation consulting services to the Biopharmaceutical industry. Multiple projects included, virtual project groups, computer systems validations, facility qualifications, cleaning and process validations, pre and post audit remediation consulting, client-privileged audits, business process improvement consulting and business partnership developments.
Chiron VaccinesProject Manager
Jan. 1996 - Dec. 1999
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