Jennifer Whitaker Email and Phone Number
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Jennifer Whitaker is a Vice President Global Compliance Quality Systems and Regulatory at KBI Biopharma. She possess expertise in quality assurance, validation, gmp, biotechnology, change control and 9 more skills.
Kbi Biopharma
View- Website:
- kbibiopharma.com
- Employees:
- 1637
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Vice President Global Compliance Quality Systems And RegulatoryKbi BiopharmaDurham, Nc, Us
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Vice President Global Compliance Quality Systems & RegulatoryKbi Biopharma Jul 2022 - PresentDurham, North Carolina, UsVice President of all Global Compliance and Quality Systems functions and harmonization over multiple KBI sites of the following: Inspection Readiness and Inspection Management, Quality Agreements, Client Audits, Quality Management Review, Risk Management Review, Internal Audits; Training and ComplianceWire system owner; Quality Systems Management and Compliance (Deviation and CC Certification, EtQ edms system owner); Regulatory Compliance (site registrations, submission support, regulatory surveillance).
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Senior Director, Global Compliance And Quality SystemsKbi Biopharma Apr 2021 - Aug 2022Durham, North Carolina, UsSr. Director of all Global Compliance and Quality Systems functions and harmonization over multiple KBI sites of the following: Inspection Readiness and Inspection Management, Quality Agreements, Client Audits, Quality Management Review, Risk Management Review, and Internal Audits; Training, Quality Systems Management and Compliance (Deviation and CC Certification, EtQ and ComplianceWire system owner).
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Director, Global ComplianceKbi Biopharma Feb 2021 - Apr 2021Durham, North Carolina, UsDirector of Global Compliance functions and harmonization over multiple KBI sites of the following: Inspection Readiness and Inspection Management, Quality Agreements, Client Audits, Quality Management Review, Risk Management Review, and Internal Audits.
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Qa Associate Director - Batch DispositionFujifilm Diosynth Biotechnologies Dec 2018 - Jan 2021Billingham, GbResponsible for site quality agreement negotiations, milestone adherence, team of Product Managers performing batch disposition, to include project readiness, client management, approval of master documentation, executed record review, batch deviation management, quality operations on the floor. -
Qa Senior Manager - Quality Systems And Cgmp ComplianceFujifilm Diosynth Biotechnologies Nov 2015 - Jul 2019Billingham, GbResponsible for site cGMP Compliance and Quality Systems (including oversight for Change Control, CAPAs, Deviations), Quality System Compliance site Metrics, site Document Control (EDMS), Internal Audits, Client Audits, and Regulatory Agency Inspections. Site lead for Regulatory Inspection Preparation and execution, Lead Host and Lead Backroom, Managed internal team for Inspections and Response preparation. Managed site through multiple FDA PAI and generals, MHRA PAI and re-inspection, ANVISA PAI and re-inspection, MHLW re-inspection.
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Qa Senior Manager - Quality Systems, Operations, And Cgmp ComplianceFujifilm Diosynth Biotechnologies Apr 2015 - Nov 2015Billingham, GbResponsible for site cGMP Compliance and Quality Systems (including oversight for Change Control, CAPAs, Deviations), Equipment, Cleaning, and Facility / Utility Validation, Quality System Compliance site Metrics, site Document Control (EDMS), Internal Audits, Client Audits, and Regulatory Agency Inspections, Regulatory Compliance oversight. Site lead for Regulatory Inspection Preparation and execution, Co-Host and Lead Backroom, Managed internal team for Inspections and Response preparation
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Qa Senior Manager - Operations And Stability ComplianceFujifilm Diosynth Biotechnologies Aug 2014 - Apr 2015Billingham, GbPromotion for QA Oversight for Equipment and Cleaning Validation, Analytical Instrument Qualification / Validation, Materials Control (Labeling / Release), SOP and Deviations for Operational Compliance, Stability Program
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Qa Manager - Operations And Stability ComplianceFujifilm Diosynth Biotechnologies Feb 2014 - Aug 2014Billingham, GbQA Oversight for Equipment and Cleaning Validation, Analytical Method and Instrument Qualification / Validation, Laboratory Data Review, Materials Control (Labeling / Release), SOP and Deviations for Operational Compliance, Stability Program
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Qa Manager - Internal AuditsFujifilm Diosynth Biotechnologies Nov 2012 - Feb 2014Billingham, Gb
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Sr. Qa Technical Specialist - Internal AuditorFujifilm Diosynth Biotechnologies Nov 2011 - Nov 2012Billingham, Gb
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Qa Technical SpecialistDiosynth Biotechnology Nov 2007 - Oct 2011Deviation investigations
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Validation SpecialistTalecris Biotherapeutics Aug 2006 - Oct 2007Equipment, Cleaning, Process Validation
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Engineer Ii - Process And Cleaning ValidationDiosynth Jan 2002 - Aug 2006
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Fermentation Mfg, Lead And SupervisorCovance May 1999 - Dec 2002Princeton, New Jersey, Us
Jennifer Whitaker Skills
Jennifer Whitaker Education Details
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North Carolina State UniversityFood Science And Technology
Frequently Asked Questions about Jennifer Whitaker
What company does Jennifer Whitaker work for?
Jennifer Whitaker works for Kbi Biopharma
What is Jennifer Whitaker's role at the current company?
Jennifer Whitaker's current role is Vice President Global Compliance Quality Systems and Regulatory.
What is Jennifer Whitaker's email address?
Jennifer Whitaker's email address is je****@****mdb.com
What is Jennifer Whitaker's direct phone number?
Jennifer Whitaker's direct phone number is +191946*****
What schools did Jennifer Whitaker attend?
Jennifer Whitaker attended North Carolina State University.
What skills is Jennifer Whitaker known for?
Jennifer Whitaker has skills like Quality Assurance, Validation, Gmp, Biotechnology, Change Control, Quality System, Cleaning Validation, Sop, Fda, Capa, Fermentation, 21 Cfr Part 11.
Who are Jennifer Whitaker's colleagues?
Jennifer Whitaker's colleagues are David Jason Mayer, Pmp, Robert Finn, Anne Lestinsky, Patricia Mendoza-Anselmi, Amphayphet Thongkheuang, Matthew Damick, Giacomo Sanna.
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