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Make compliance a competitive advantage!If you want to attract and retain customers, then you need to build quality into your products. Not doing so puts your relationship with your customers at risk. The right leadership and experience make all the difference.As an results-driven executive with a highly successful, 25 plus year track record of creating, implementing and managing quality systems, as well as industry aligned operations and regulatory procedures, my consulting firm offers compliance programs that protect your business and exceed expectations – each and every time. I believe that an upbeat attitude, collaborative approach and a decisive, articulate manner is the foundation for strong leadership. My approach to problem-solving starts with understanding your business needs to ensure integration and alignment of quality/regulatory programs amidst the backdrop of an ever-changing domestic and international regulatory environment. I am a proud graduate of Dale Carnegie’s Management Training and have demonstrated an ability to effectively communicate with all organizational levels and functional areas.Specialties: Global & Domestic Goal-Setting for Quality Team ● Quality Systems Design ● Gap, Due Diligence & Vendor Audits ● Electronic Documentation & Inventory Management Systems Development ● FDA Regulatory/Registrations and Liaison ● New Business Development ● Training Programs ● Executive Management Presentations ● Cross-Functional Team Leadership ● Staff Management ● Collaboration with Inventory Control, Purchasing, Manufacturing & Production ● Client & Customer Relations ● Certified ISO 22716 auditor ● Experience with EFfCI compliance/auditing ● Quality systems remediation ● Consent decree ● Warning letters
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Director Of Quality And ProcessingFresh Mar 2020 - PresentNew York, Ny, Us -
President And Chief Solution ConsultantIqa Consulting Services, Llc 2010 - PresentIQA Consulting Services, LLCExecutive of a consulting firm providing quality and compliance services to FDA regulated manufacturers, distributors, companies and suppliers. Programs are tailored for a range of companies, from Fortune 500 corporations to start-ups. Our team of consultants have a range of expertise that comprise: FDA regulated product manufacturing, packaging, Quality Assurance, Laboratory Operations and Regulatory Affairs. Services include:• Creation, implementation and management of Quality Systems for the following standards and regulations: cGMP, ISO 13485, ISO 22716, ISO 15378, ISO 9001, ICH Q7 and EFfCI• Manufacturing, Quality and Complaint investigations• Training, technical writing and SOP development• CAPA and change control management• FDA Field Alerts, 483s, recalls and consent decree remediation• Supplier, API, contract manufacturing and packaging, internal and third party auditing• Full support as a virtual quality/compliance department• Subject Matter Expert for Quality, QC Laboratory and FDA related issuesPartial Client List (for full client list, case studies, and testimonials visit website at: http://www.iqaconsulting.com/expertise.html):SGSProctor and Gamble Co IncJohnson and Johnson Consumer Products Inc.Maquet CardiovascularCroda Inc.Marietta CorporationAbbott Point of CareHenkel Inc.Archer Daniels Midland CorporationAshland Specialty IngredientsCircadia Inc.Iris Beauty Supplies Inc.Lonza Inc.LEKHarrison Specialty Inc.The Monarch Group c/o Swissplas LimitedMcNeil Consumer HealthcareMWVOxygen Development LLCTEVA Pharmaceuticals -
Senior Trainer Medical Devices And PharmaceuticalsCompliance Trainings Mar 2014 - Mar 2020
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Senior Management ConsultantOriel Stat A Matrix Apr 2015 - Jan 2018Washington, Dc, Us -
Director Of Quality AssuranceDimensional Merchandising Inc. 2008 - 2010Wharton, Nj, UsLeader of quality and regulatory teams for an FDA registered manufacturer, packager and filler of medical devices, OTC drugs, and cosmetics. Responsible for: development of strategic global initiatives to expand resident product lines and meet client-driven business goals; system improvements that continuously meet clients’ rigorous quality needs; oversight of daily output to meet client deadlines; and executive presentations for existing accounts and new business. Clients include over 30 leading global pharmaceutical and cosmetics companies.• Implemented system improvements that drove 28% increase in revenue. Enhancements included: staff re-structuring and training to improve technical proficiency; upgrades and purchases in quality control laboratory and equipment; strategic implementation of electronic controls of material into inventory management software; and HVAC and building upgrades. Improvements allowed for proper control, reconciliation and compliance, resulting in: - a 25% increase in staff productivity and equipment control; - an increase in QA/QC control by over 65% - a 40% increase in product compliance rate• Integrated Quality functions into 21 CFR Part 11 compliant software to expand quality functionality/capability into an existing inventory control system. This increased visibility of quality function to production and planning, allowing for a 65% decrease in shipping time. -
Director, Quality AssurancePrestige Brands, Inc. 2006 - 2008Responsible for instituting corporate quality and regulatory operations for medical device, drug, OTC and cosmetics manufacturer. Managed staff, implemented systems, and trained employees to GMP/QSR/Canadian and ISO compliant systems. Led FDA, Health Canada (DIN/NPN) and worldwide regulatory submissions and registrations. Developed metrics and methods for tracking and trending quality system effectiveness. Managed APR, stability, new product quality requirement and quality system documentation.• Coordinated with FDA, Health Canada and other global regulatory bodies to register, manufacture and ship OTC drug/Medical Device products to global market in record time (less than 6 mos).• Increased profitability and productivity by approximately 50%, • Improved reject rates by approximately 35% • Decreased turnaround time by approximately 40%• 0 FDA inspection observations accrued over 1 FDA audit and 1 Health Canada audit.
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Sr. Manager QaVyteris Inc. 2004 - 2005UsResponsible for management of GMP, ISO and corporate compliance functions for manufacturer of a transdermal combination product (medical device/pharmaceutical). Rebuilt CMP/QSR compliant structure and systems in less than 7 months. Accountable for upgrading and executing vendor auditing and qualification program. Created SOPs, batch and validation records. Enjoined executive management in quality initiatives. Trained and motivated staff and analytical testing department. Provided guidance for software/hardware validation. -
Director Of Quality AssuranceL'Oreal Usa 2000 - 2003Paris, FrResponsible for creation, implementation and management of quality systems and programs and leadership for QA/QC staff. Achieved ISO 9001 certification for facility in 11 months. Instituted collaborative and operational measures to control costs and increase quality for 320 different SKUs and 10 product types. Decreased component rejects by 43% by instituting supplier auditing and monitoring; wrote and implemented 120 SOPs; instituted aggressive measures to reduce scrap rates from 38% to 7% on 11 manufacturing lines.
Jan Warner Ms, Mba Skills
Jan Warner Ms, Mba Education Details
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New Jersey Institute Of TechnologyTotal Quality Management -
New Jersey Institute Of TechnologyManagement Of Technology
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Stony Brook UniversityBiology/Chemistry
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Commack High School North
Frequently Asked Questions about Jan Warner Ms, Mba
What company does Jan Warner Ms, Mba work for?
Jan Warner Ms, Mba works for Fresh
What is Jan Warner Ms, Mba's role at the current company?
Jan Warner Ms, Mba's current role is Director of Quality and Processing at fresh.
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What schools did Jan Warner Ms, Mba attend?
Jan Warner Ms, Mba attended New Jersey Institute Of Technology, New Jersey Institute Of Technology, Stony Brook University, Commack High School North.
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What skills is Jan Warner Ms, Mba known for?
Jan Warner Ms, Mba has skills like Fda, Gmp, Quality System, Validation, Capa, Quality Assurance, Cross Functional Team Leadership, Change Control, Quality Management, Sop, Regulatory Affairs, Quality Control.
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