Joe Link

Joe Link Email and Phone Number

Site QA Head at BeiGene @ BeiGene
Joe Link's Location
East Hanover, New Jersey, United States, United States
Joe Link's Contact Details

Joe Link personal email

n/a

Joe Link phone numbers

About Joe Link

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

Joe Link's Current Company Details
BeiGene

Beigene

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Site QA Head at BeiGene
Joe Link Work Experience Details
  • Beigene
    Site Qa Head
    Beigene Sep 2022 - Present
    Cambridge, Ma, Us
  • Hmc Enterprises Llc
    Consultant - Hmc Enterprises, Llc - Providing Qa Services To Pharma And Biotech Customers
    Hmc Enterprises Llc Jan 2022 - Sep 2022
  • Novartis Cell And Gene Therapy
    Product Quality Leader
    Novartis Cell And Gene Therapy Sep 2018 - Dec 2021
    Provide Quality oversight for the CGT Development organization. Support introduction of new products and clinical trails for Kymriah.
  • Novartis Pharma
    Head Qa Compliance, Us Cpo
    Novartis Pharma Jan 2015 - Sep 2018
    Director - 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
  • Novartis Pharma
    Qa Compliance Lead - Eso
    Novartis Pharma Apr 2013 - Jan 2015
    Resposible 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.
  • Novartis Pharmaceuticals
    Head Of Dra Qa Compliance
    Novartis Pharmaceuticals Jan 2011 - Apr 2013
    Basel, Baselstadt, Ch
    Responsible 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.
  • Novartis Vaccines And Diagnostics
    Senior Director Of Quality Operations, Novartis Vaccines & Diagnostics
    Novartis Vaccines And Diagnostics Nov 2008 - Dec 2010
    Short 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.
  • Novartis Vaccines
    Senior Director Of Quality Operations, Novartis Vaccines
    Novartis Vaccines Apr 2007 - Oct 2008
    Championed 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.
  • Ciba Vision Sterile Mfg, Toronto, Canada (Cvsm)
    Director Of Qa/Qc And Reg. Affairs
    Ciba Vision Sterile Mfg, Toronto, Canada (Cvsm) May 2004 - Mar 2007
    International 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
  • Novartis
    Validation Manager
    Novartis 2002 - 2004

Joe Link Skills

Cgmp Aseptic Processing Capa Fda Biopharmaceuticals Vaccines Process Validation Quality Assurance Quality Management Quality Systems Sop Validation Gmp Compliance Pharmaceuticals Gxp Regulatory Affairs Change Control Biotechnology 21 Cfr Part 11 Pharmaceutical Industry Computer System Validation Regulatory Requirements Analytical Method Validation Quality System Gamp Glp Trackwise U.s. Food And Drug Administration

Joe Link Education Details

  • Long Island University
    Long Island University
    Pharmacuetical 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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