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Senior Quality associate with extensive experience managning tranformational change in a business critial setting. Hands on leader who enjoys working in a fast paced environment. Experiences includes leading global projects, new proudct launches and manufacturing site quality turn arounds
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Site Qa HeadBeigene Sep 2022 - PresentCambridge, Ma, Us -
Consultant - Hmc Enterprises, Llc - Providing Qa Services To Pharma And Biotech CustomersHmc Enterprises Llc Jan 2022 - Sep 2022 -
Product Quality LeaderNovartis Cell And Gene Therapy Sep 2018 - Dec 2021Provide Quality oversight for the CGT Development organization. Support introduction of new products and clinical trails for Kymriah.
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Head Qa Compliance, Us CpoNovartis Pharma Jan 2015 - Sep 2018Director - US Country Pharma Org (CPO) QA Compliance Lead – Responsible for the GMP Compliance of US CPO Commercial products in accordance with the Novartis Quality Manual and the processes defined by Global Quality. The position is responsible for ensuring appropriate oversight, assessment and mitigation of risk to quality practices and processes, and for ensuring that all aspects of the US CPO are in compliance with cGxP’s, regulatory requirements and the Novartis Quality Manual
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Qa Compliance Lead - EsoNovartis Pharma Apr 2013 - Jan 2015Resposible for products and CMOs managed from NJ in accordance with the Novartis Quality Manual and the processes defined by ESO. Responsible for ensuring appropriate oversight, assessment and miti-gation of risk to quality practices and supply, and for ensuring that all aspects of the relationship, and the management thereof, are in compliance with cGMP and regulatory requirements, the No-vartis Quality Manual, and industry practices. Leads the team of compliance experts supporting the External Supply Organization.
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Head Of Dra Qa ComplianceNovartis Pharmaceuticals Jan 2011 - Apr 2013Basel, Baselstadt, ChResponsible for a global team of associates focusing on Developmnent QA and Regulatory Compliance. Focused on Quality Systems implementation and GxP enhancements to existing systems and processes. -
Senior Director Of Quality Operations, Novartis Vaccines & DiagnosticsNovartis Vaccines And Diagnostics Nov 2008 - Dec 2010Short Term International Assignment, in Marburg Germany. Lead the site during fast paced and challenging operations to support flu vaccine supply for the H1N1sw Pandemic.• Lead the site through the fast track (6 –months) Pandemic Vaccines development & launch of a new FCC product Celtura®, that was licensed in Germany, Switzerland and Japan.• Supported fast track development of a sterile mix and match adjuvant, sterile MF-59® Licensed in Korea.
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Senior Director Of Quality Operations, Novartis VaccinesNovartis Vaccines Apr 2007 - Oct 2008Championed Quality Systems and GMP facility design and green field start up activities for the Holly Springs site. Built a high performing team shaping an execution culture that is team based and compliance focused.• Championed successful FDA Type “C” meeting for site design approval.• Built a team of professional associates to champion quality systems operational readiness of the Holly Springs Site.
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Director Of Qa/Qc And Reg. AffairsCiba Vision Sterile Mfg, Toronto, Canada (Cvsm) May 2004 - Mar 2007International Assignment in Canada (seconded to Ciba Vision by Novartis Pharma) championing a site GMP and Quality Culture Upgrade. Experience gained in sterile manufacturing of Ophthalmic Drug Products and Lens Care Product Medical Devices. Accountable for the sites quality performance to both Ciba Vision Corp and regulatory authorities. Re-organized and built a high performing quality organization focused on right first time quality, accountability, and customer service. Lead CVSM successfully through regulatory inspections and Novartis Corp. Quality Audits.• Hired and developed managers and staff to successfully run the QA/QC unit of a cGMP aseptic processing facility for sterile product manufacturing.• Successfully lead a site wide GMP upgrade project implementing quality systems. • Developed QA KPI’s to ensure critical to quality metrics are transparent
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Validation ManagerNovartis 2002 - 2004
Joe Link Skills
Joe Link Education Details
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Long Island UniversityPharmacuetical Chemistry
Frequently Asked Questions about Joe Link
What company does Joe Link work for?
Joe Link works for Beigene
What is Joe Link's role at the current company?
Joe Link's current role is Site QA Head at BeiGene.
What is Joe Link's email address?
Joe Link's email address is jo****@****tis.com
What is Joe Link's direct phone number?
Joe Link's direct phone number is +41 61 324 *****
What schools did Joe Link attend?
Joe Link attended Long Island University.
What are some of Joe Link's interests?
Joe Link has interest in Science And Technology, Education, Health.
What skills is Joe Link known for?
Joe Link has skills like Cgmp, Aseptic Processing, Capa, Fda, Biopharmaceuticals, Vaccines, Process Validation, Quality Assurance, Quality Management, Quality Systems, Sop, Validation.
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