Mandy Wagner, PMP

CEO/Founder/Recruiter at GxP Solutions Recruiting
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Contact Information
us****@****om
(386) 825-5501
Location
Vaughan, Ontario, Canada, CA
Languages
  • English -
  • French -

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I highly recommend Mandy for her exceptional support throughout my job search. She helped me right from the beginning, from resume review to preparing for the interview, making the entire process much easier. She was a great mentor, providing valuable insights and encouraging a thorough examination of all details before making decisions. Mandy possesses a deep industry knowledge and dedication, making her an excellent choice for anyone seeking career guidance and opportunities.

Mark Ezard

I highly recommend Mandy Wagner. Mandy helped me find a job that was right for me. she is very informative about how to be confident during interviews. if you need help with your resume Mandy will help you out and give you suggestions. Thank you Mandy for helping me with my new career, you are awesome

MOOSA GHANSH

Mandy was extraordinary supportive and helpful before and after my interview, she always encouraged me and helped me during my entire job application process, She was always there to coach and guide me with a big smile on her face, I thoroughly enjoyed my time working with Mandy. I am really thankful to her and would positively recommend her to her clients.

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Credentials

  • Project Management Professional
    Project Management Institute
    Jun, 2009
    - Nov, 2024
  • GMP Auditor
    Academy of Applied Pharmaceutical Sciences
    Jan, 2006
    - Nov, 2024
  • GMP Regulations
    Academy of Applied Pharmaceutical Sciences
    Jan, 2005
    - Nov, 2024
  • Project Management Professional (PMP)®
    Project Management Institute
    Jun, 2009
    - Nov, 2024

Experience

  • GxP Solutions Recruiting
    • Canada
    • Staffing and Recruiting
    • 1 - 100 Employee
    • CEO/Founder/Recruiter
      • Mar 2021 - Present

      Seasoned GxP SMEs consulting in the pharmaceutical industry for over 10 years with 30 years of industry knowledge and experience. Our "GxPertise" allows us to use that hands-on comprehensive background to provide the best talent for your unique roles. EXPERIENCE MATTERS. It takes one, to know one! As former life science hiring managers, we know what it takes to succeed in the industry! This is our GxP Advantage! We specialize our recruiting activities in the following areas: - Healthcare - Pharmaceuticals (Quality, Compliance, Regulatory Affairs, Clinical Trials, Pharmacovigilance, Medical Information/Med Affairs, Validation) - Specialty Pharma - NHPs - Biotechnology - Medical Devices - Supply Chain, Logistics, Transportation & Cold Chain Management CONSULTATIVE PARTNERSHIP: Our ability to leverage our comprehensive industry knowledge and expertise to be your problem-solving & industry partner empowers us to deliver candidates who are tailor-made for your role. We have a consultative, relationship-first approach with honesty, transparency, integrity, & DEI. Our goal is to be a strategic partner invested in your success. Guided by a growth mindset and collaborative spirit, we provide solutions that surpass the confines of job descriptions. CANDIDATE ADVOCATE: It's not about what's in it for us; it's about what's in it for you! We are not only recruiters, but we are relationship builders, career concierges/coaches providing the best candidate experience, paying it forward to usher candidates toward success from the first call to well beyond job placement. LET'S PIONEER CHANGE TOGETHER: Whether you're seeking a fulfilling career or exceptional talent, let's embark on this transformative journey together. A single connection is all it takes to set the wheels in motion. Reach out to us at info@gxpsolutions.ca, and let's embark on a conversation that could change your future and meet the ever-evolving needs of your organization. Get GxPertised for success! Show less

  • GxP Solutions Consulting
    • Vaughan, ON Canada
    • CEO/Founder/GxP Consultant
      • Mar 2013 - Present

      GxP Solutions has 30 years of hands-on pharmaceutical industry experience. We specialize in a variety of GxP consulting services for the pharmaceutical, biotech, healthcare, medical device, clinical, and supply chain/logistics/3PLS industries. GxP Solutions has 30 years of hands-on pharmaceutical industry experience. We specialize in a variety of GxP consulting services for the pharmaceutical, biotech, healthcare, medical device, clinical, and supply chain/logistics/3PLS industries.

  • MT Talent Solutions Inc.
    • Canada
    • Staffing and Recruiting
    • 1 - 100 Employee
    • Pharmaceutical and Healthcare Recruiter
      • Aug 2022 - Apr 2023

      My previous career experience in healthcare and the pharmaceutical industry along with my passion about helping both bilingual and unilingual candidates find the career they will love within the pharmaceutical and healthcare industries helps me to provide an excellent and memorable candidate experience. My previous career experience in healthcare and the pharmaceutical industry along with my passion about helping both bilingual and unilingual candidates find the career they will love within the pharmaceutical and healthcare industries helps me to provide an excellent and memorable candidate experience.

  • Aixal Consulting
    • Canada
    • Staffing and Recruiting
    • 1 - 100 Employee
    • Consultant Recruiter
      • Jan 2022 - Apr 2022

      Placed in the following industries to date: automotive, biotech, engineering, supply chain/logistics, manufacturing, and construction. Aixal Consulting brings a fresh approach to executive recruiting, combining expertise in leadership development, performance consulting, and client service, while aligning strategic insights and solutions to the specific needs of our clients. Placed in the following industries to date: automotive, biotech, engineering, supply chain/logistics, manufacturing, and construction. Aixal Consulting brings a fresh approach to executive recruiting, combining expertise in leadership development, performance consulting, and client service, while aligning strategic insights and solutions to the specific needs of our clients.

  • McKesson Canada
    • Canada
    • Hospitals and Health Care
    • 700 & Above Employee
    • Senior Quality Process Improvement Specialist
      • Jan 2018 - Jan 2022

      As the Business Partner for INVIVA - National network of infusion clinics and home nursing program and part of their Operational Leadership Team played a key role/led various critical projects such as Clinic Accreditation, Health Ministry Requested Privacy Information Assessments, Fridge Monitoring/Cold Chain and Transportation Projects. - Developed, streamlined and implemented processes for various Quality Management Systems such as: Documentation, Recalls, Change Controls, Deviations, CAPAs, Incidents, Complaints, Audits, and Training. Manage all the previously-listed Quality Management Systems for INVIVA. - Oversaw all aspects of INVIVA internal and external audits from developing an audit preparation program, organizing and leading all audits, to drafting and closing out all audit CAPAs. - Responsible for monthly reporting all Quality Management System metrics/KPIs to Executive Management and leading Quarterly Quality Management Meetings. - Served as Quality lead for electronic QMS system. - Oversaw entire lifecycle of process/document development, approvals and training. - Lead all recalls, privacy incidents and review all contracts for all matters related to Quality. - Managed all fridge/medication-related issues and provides stability-based drug dispositions during and after business hours. - Organized annual Inclusion and Diversity Day and am a lead on the Change Champion Team for Quality. Show less

  • MediSystem Pharmacy
    • Canada
    • Hospitals and Health Care
    • 200 - 300 Employee
    • Quality Specialist, Quality Dept., Operations
      • Jul 2016 - Dec 2017

      A division of Shoppers Drug Mart - Member of Senior Management Team - Hired to start and manage a new Quality Department in Corporate Operations and build the Quality framework for change management, documentation and process development, document review/approval, training, and compliance. - Hired Quality Coordinator to oversea more junior Quality tasks - Managed organizational project to document all department processes. Lead/managed various process improvement projects. Participated in various senior management teams. - Established and maintained mechanisms to review, approve and track the implementation and adoption of formalized procedures and processes. - Standardized all organizational processes and associated documentation. Show less

  • Purdue Pharma (Canada)
    • Canada
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • QA Associate (Consultant)
      • Jan 2015 - Dec 2015

      QA: SHORT-TERM ERP/JDE PROJECT - Processed and closed change controls, revise master production and packaging batch records - Completed product complaints and drafted 3 complaint white papers in order to expedite closure of various complaints for a transdermal patch MANUFATURING: SHORT-TERM PROJECT: - Processed, monitor and close CAPAs, Change Controls, deviations, revise SOPs and provide process improvement for Production and Packaging documents. QA: SHORT-TERM ERP/JDE PROJECT - Processed and closed change controls, revise master production and packaging batch records - Completed product complaints and drafted 3 complaint white papers in order to expedite closure of various complaints for a transdermal patch MANUFATURING: SHORT-TERM PROJECT: - Processed, monitor and close CAPAs, Change Controls, deviations, revise SOPs and provide process improvement for Production and Packaging documents.

  • Apotex Inc.
    • Canada
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Documentation Specialist/Tech Writer (Consultant)
      • Mar 2013 - Sep 2014

      18-MONTH LEAN DOCUMENTATION PROJECT: - Revised Standard Operating Procedures (SOPs) and Work Instructions (WIs) with Subject Matter Experts - Developed training materials - Trained users 18-MONTH LEAN DOCUMENTATION PROJECT: - Revised Standard Operating Procedures (SOPs) and Work Instructions (WIs) with Subject Matter Experts - Developed training materials - Trained users

  • Merck KGaA, Darmstadt, Germany
    • Germany
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • QA Project Manager
      • Aug 2005 - Jun 2012

      Pharmacovigilance - Managed all domestic & foreign drug safety activities: 2005 to 2008: - Processed AEs/notifications to HC & Global PV - Maintained AE database/case files - Developed domestic drug reporting processes & reporting forms. - Trained Call Centre and new Drug Safety Manager on AE & domestic drug reporting processes. - Conducted Pharmacovigilance pre-inspection audits for new PV group. Quality - Managed various quality systems: drug/clinical product and device releases, complaints, deviations and CAPAs, change control, SOPs/WIs, training, internal & external audits, returns/destruction, metrics and vendor management. Significantly reduced complaints by developing: - Complaints Guidelines for troubleshooting and training for Call Centre and Sales & Marketing teams (50% reduction in complaints) - Packaging prototype to stabilize an electronic auto-injector device while in transit, reducing product damage and increasing confidence & use of device - QC program for the electronic auto-injector device - New user technique for handling an injector in response to user complaints, introduced technique globally which reduced global complaints for bent needles in the device - Discovered root causes of device complaints, presented findings globally which resulted in label changes, device retraining for Sales/Marketing & a reduction of global complaints - Served as Quality lead for product launches - Lead a Cold Chain Management project to secure a validated cold chain shipping container. - Key participant in global project to reduce temperature excursions for incoming products. - Reviewed product packaging, labels/inserts, monographs, and marketing pieces in English & French - Main QA contact for DC/warehouse & Call Centre. - Developed annual GMP Training Plan & facilitated training. - Conducted annual GMP audits of 3rd party suppliers & internal audits for QA. - Assisted in preparation and participated in for Health Canada & Corporate inspections Show less

  • Calea Ltd.
    • Canada
    • Hospitals and Health Care
    • 1 - 100 Employee
    • Medical Information and Drug Safety Specialist
      • 2004 - 2005

      - Provided specialized medical information to healthcare professionals as a Pfizer rep - Collected post-marketing AE data and product complaint information - Provided specialized medical information to healthcare professionals as a Pfizer rep - Collected post-marketing AE data and product complaint information

  • Dimethaid Health Care
    • Markham, ON
    • Medinfo Associate
      • 2002 - 2004

      Oversaw the creation of a new Medical Information/Drug Safety Department: - Authored, implemented and trained staff on medical information, drug safety, recall, complaints and Special Access Program SOPs - Responded to requests for medical information and collected AE and product complaint information - Assisted in the setup of medical information services for the UK, Italian and Portuguese distributors Oversaw the creation of a new Medical Information/Drug Safety Department: - Authored, implemented and trained staff on medical information, drug safety, recall, complaints and Special Access Program SOPs - Responded to requests for medical information and collected AE and product complaint information - Assisted in the setup of medical information services for the UK, Italian and Portuguese distributors

  • Aucxis Corporation Inc.
    • Toronto, ON
    • Office and Project Manager
      • 1999 - 2001

      - Designed and deployed 2 new offices - Managed supplier contracts while liaising with Directors to present bi-weekly project status reports and schedules - Authored and managed company SOPs and conducted staff training - Led 3 projects: financial website, change management and version control - Managed all HR functions - Designed and deployed 2 new offices - Managed supplier contracts while liaising with Directors to present bi-weekly project status reports and schedules - Authored and managed company SOPs and conducted staff training - Led 3 projects: financial website, change management and version control - Managed all HR functions

  • Procter & Gamble
    • United States
    • Manufacturing
    • 700 & Above Employee
    • MedInfo and Reg Affairs Associate/Project Manager
      • 1997 - 1999

      MEDICAL INFORMATION AND DRUG SAFETY ASSOCIATE - SHORT-TERM, REPLACEMENT CONTRACT 1997 to 1998 - Responded to all drug-related inquiries from healthcare professionals and consumers, collected AE data for the pharmacovigilance database. - Led a project to compile article and reference information into a reference manager database. REGULATORY AFFAIRS ASSOCIATE/PROJECT MANAGER - SHORT-TERM, REPLACEMENT CONTRACT 1998 to 1999 - Managed a large project to reorganize the resource and reference library (including physical layout), compiled Therapeutic Products Directorate Guidelines -Established an effective retrieval system for each RA manager - Aided in the preparation of Regulatory submissions - Organized technical training for RA and Medical Information staff Show less

  • The Hospital for Sick Children
    • Canada
    • Hospitals and Health Care
    • 700 & Above Employee
    • Department and Intake Coordinator
      • 1995 - 1997

      - Restructured intake forms for referrals - Revised processes to ensure speech pathologists were more efficient in the assessment process - Organized nasopharyngoscopy and parent workshops - Transcribed initial and follow-up assessment reports - Registered new patients - Supervised department volunteers - Restructured intake forms for referrals - Revised processes to ensure speech pathologists were more efficient in the assessment process - Organized nasopharyngoscopy and parent workshops - Transcribed initial and follow-up assessment reports - Registered new patients - Supervised department volunteers

  • Mount Sinai Hospital (Toronto), Sinai Health
    • Canada
    • Hospitals and Health Care
    • 700 & Above Employee
    • Office Manager
      • 1993 - 1996

      Hired to set up new vascular surgery practice and processes for vascular researcher/surgeon. - Managed day to day operations of a vascular surgery practice with ties to Toronto General Hospital (TGH) vascular surgery practice. - Pre and Post-surgery patient counselling - Billing - Day-surgery preparations - Transcribed all medical documentation - Initial and Follow-up Assessments, OR and Discharge Summaries, Post-Surgery Follow-up Reports - Summarized clinical trial information on Ischemic Reperfusion Injury - Followed surgery admitting procedures for MSH and TGH - Drafted pre and post-surgery patient counselling - Acted as physician assistant - debriding, bandage changes Show less

  • Medcare Hospitals & Medical Centres
    • United Arab Emirates
    • Hospitals and Health Care
    • 700 & Above Employee
    • Medical Office Assistant/Receptionist
      • 1991 - 1994

      - Patient reception (booked and walk-in patients) for extremely busy physicians office - Registered new patients - Reported laboratory results to patients - Transcribed medical reports - Filed patient results - Processed prescription renewals - Dealt with Pharmaceutical Sales Reps and checked expired sample medications - Developed Training Manual for new hires and trained new staff - Acted as physician's assistant when required - Patient reception (booked and walk-in patients) for extremely busy physicians office - Registered new patients - Reported laboratory results to patients - Transcribed medical reports - Filed patient results - Processed prescription renewals - Dealt with Pharmaceutical Sales Reps and checked expired sample medications - Developed Training Manual for new hires and trained new staff - Acted as physician's assistant when required

Education

  • Victoria College
    Diploma, Project Management
    2009 - 2009
  • Academy of Applied Pharmaceutical Sciences
    Diploma, QA and Audit Management
    2005 - 2006
  • Seneca College
    Diploma, Medical Office Management/Administration
    1992 - 1994

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