Summary
Overview
Work History
Education
Skills
Systems
Timeline
Generic

Blair Josey

Summary

Passionate team player and people leader with High sense of Urgency and agile mindset.


E2E Business Acumen & Partnering Capabilities with Cross-sector experience (Skin health, Essential Health, Selfcare, Dietary Supplements, Food).


Experienced People Leader dedicated to fostering an inclusive environment for coaching & Continuous Improvement


Customer-centric mindset to reduce process complexity and and drive business efficiencies


Experience with global portfolio of IM/EM sites and governing body regulations (Canada, US, EMEA, LATAM, APAC)

Overview

22
22
years of professional experience

Work History

Manager, External Quality (FQ Canada)

Kenvue
11.2023 - Current
  • Oversight of Canadian Batch Release to market
  • Support to Canadian Drug Establishment licensing and Table A management (API suppliers)
  • Management support to EMQ Leads for Canadian selfcare sites
  • GRC Guest Auditor Support to multiple 2024 inspections (Lead Auditor)
  • Change management, INV/CAPA Creator and Approver Roles
  • NTM/escalations
  • Support to CQ Trade Customization process efficiencies
  • Oversight of Annual Canadian GMP Programs: Full Documentation Review; Confirmatory testing; Unique Identifier Program
  • Leading B. cepacia micro remediation project at Trillium Healthcare for Kenvue liquid formulations
  • ADPR Reviews, Quality Agreements
  • NA Compendial Review Governance Team


Manager, External Manufacturing Quality (NA)

Kenvue
05.2023 - 11.2023
  • Oversight of Canadian Batch Release to market
  • Management support to EMQ Leads for Canadian selfcare sites
  • GRC Guest Auditor Support to multiple GRC inspections and Internal Audits (Lead Auditor)
  • Change Management Creator and Approver Roles
  • INV/CAPA Creator and Approver roles
  • NTM/escalations, Quality Agreements
  • Support to CQ Trade Customization Streamlining and process efficiencies
  • Oversight of Annual Canadian GMP Programs: Full Documentation Review; Confirmatory testing; Unique Identifier Program
  • Oversight of NA EMQ Full Batch Review Program & Tracking
  • On site Support to EM Quality Business Reviews
  • EM Lifecycle Management

External Manufacturing Quality Lead

Kenvue
03.2020 - 05.2023
  • Canadian and US Batch Release (BtB & Mercury systems)
  • EM management activities
  • GRC Guest Auditor Support to multiple GRC inspections and Internal Audits
  • Change Management (US & Canada)
  • INV/CAPA (US & Canada)
  • NTM/escalations, Quality Agreements
  • Annual Canadian GMP Programs: Full Documentation Review; Confirmatory testing; Unique Identifier Program
  • Oversight of NA EMQ Full Batch Review Program & Tracking
  • On site Support to EM Quality Business Reviews, Inspection Readiness Assessments
  • Nutritional and Selfcare SME

Quality Engineer, NA BQ

Johnson & Johnson Surgical Vision
11.2018 - 03.2020
  • core member of the global JJSV Integration team for Project Equator.
  • JJSV QMS creation
  • This project team managed the integration of 22
    global marketing companies within the J&J surgical business, ensuring compliance of these sites to J&J
    technical standards and QMS, as well as applicable regional/local SOPs, and governing Health Authorities.
    Key learnings while in this role include the following:
  • FPX Project Management Methodology
  • Compliance Wire local/regional/global curricula creations and assignments
  • Creation of JJSV Supplier identification and risk classification process, and new supplier notification process
  • J&J purchasing controls & qualification for JJSV sites
  • International partnering for common goals
  • Understanding business & cultural differences across global regions, the importance of clear
    communication with clear “asks” and defined timelines,

EMQ Specialist III

Johnson & Johnson
06.2015 - 11.2018

Plant Hygienist

McNeil Consumer Healthcare
06.2014 - 05.2015

Compliance Specialist - EMPQ Team

Johnson & Johnson Inc.
01.2013 - 06.2014

Quality & Regulatory Compliance Specialist

Johnson & Johnson Inc.
04.2011 - 01.2013

Compliance Analyst - Consumer Quality Team

Johnson & Johnson Inc.
05.2008 - 04.2011

Associate Analyst - Microbiology Lab

McNeil Consumer Healthcare
06.2007 - 04.2008

Microbiology Lab Technician

Maple Leaf Foods
10.2006 - 05.2007

Microbiology Laboratory Technician

Kerry Ingredients Canada
11.2005 - 10.2006

Pharmacy Technician

IDA and Shoppers Drugmart Pharmacies
06.2002 - 12.2005

Education

Bachelor of Science - Bachelor's Degree in Honours Biology

University of Western Ontario
London, ON
06.2005

Skills

  • J&J Certified People Leader
  • ASQ Certified Quality Auditor(CQA) - cert# 75506
  • J&J Qualifed Quality Engineer
  • Multi-regional & Multi-sector work experience (17 yrs)
  • Canadian/US/EMEA regulations
  • multiple technologies - Liquids, solids, supplements, gummies, aseptic fill
  • New Product Launches
  • Technical Transfers & Resites
  • Plant Hygiene
  • Experienced Leading Health Authority inspections
  • ONES4 ERP Management system fluency
  • Plant floor Operations experience
  • Divestitures and Integrations

Systems

ONES4 SAP platform

US Mercury SAP system

EtQ - Skillman & Markham

NXG

Outlook, Word, Excel, PowerPoint

Compliancewire

Trackwise (legacy viewing)

SAP BtB Canada (legacy viewing)

Timeline

Manager, External Quality (FQ Canada)

Kenvue
11.2023 - Current

Manager, External Manufacturing Quality (NA)

Kenvue
05.2023 - 11.2023

External Manufacturing Quality Lead

Kenvue
03.2020 - 05.2023

Quality Engineer, NA BQ

Johnson & Johnson Surgical Vision
11.2018 - 03.2020

EMQ Specialist III

Johnson & Johnson
06.2015 - 11.2018

Plant Hygienist

McNeil Consumer Healthcare
06.2014 - 05.2015

Compliance Specialist - EMPQ Team

Johnson & Johnson Inc.
01.2013 - 06.2014

Quality & Regulatory Compliance Specialist

Johnson & Johnson Inc.
04.2011 - 01.2013

Compliance Analyst - Consumer Quality Team

Johnson & Johnson Inc.
05.2008 - 04.2011

Associate Analyst - Microbiology Lab

McNeil Consumer Healthcare
06.2007 - 04.2008

Microbiology Lab Technician

Maple Leaf Foods
10.2006 - 05.2007

Microbiology Laboratory Technician

Kerry Ingredients Canada
11.2005 - 10.2006

Pharmacy Technician

IDA and Shoppers Drugmart Pharmacies
06.2002 - 12.2005

Bachelor of Science - Bachelor's Degree in Honours Biology

University of Western Ontario
Blair Josey