Jessica Monville
Oconomowoc,WI
Summary
Diligent Quality, Regulatory and Compliance Manager with 19+ years of supporting management experience. Excels in working with cross-functional teams with the primary focus of minimizing regulatory risk. Collaborative management of priorities and problem-solving with quick turn-around and effective results. Utilizes deep knowledge of governmental regulations to ensure effective policy development, extensive stakeholder communication, and fostering collaborative team environments.
Overview
19
19
years of professional experience
Work History
Chief Regulatory Officer
American Pasteurization Company, LLC
10.2023 - Current
- Enhance regulatory compliance by developing and implementing effective policies and procedures across the network. This includes compliance to FDA, USDA, OSHA, EPA and many human resource related guidelines.
- Regularly support each functional facility leader during audits and inspections, both regulatory and 3rd party auditors.
- Champion of Key Performance Indicators utilization across Food safety, Quality, Safety and Performance Management. This allows for alignment with regulatory and customer driven expectations as well as drives continuous improvement.
- Consistently demonstrate leadership cross functionally to advance initiatives aimed at reducing organizational risk exposure with a people first mentality.
- Develop strong working relationships with all vendors, customers and regulators, to enhance trust and cooperation in addressing compliance matters.
- Manage the internal and external process for new products, changes in existing product specifications and certifications with precision and accuracy.
- With a growth mindset, lead and support over 30 direct and indirect reports across two facilities to increase the level of expertise and capabilities to strengthen production.
Manager of Food Safety and Regulatory - Americas
Molson Coors Beverage Company
04.2019 - 10.2023
- Lead and supported a multi-facility network to advance the adherence to food safety practices and the development of enhanced Food Safety Management Systems.
- Advised facility leaders across all production facilities to prepare and anchor initiatives that would allow for 3rd party certification program compliance.
- Collaboratively with internal and external legal partners, ensured product labeling, ingredients, nutritional facts and marketing claims and statements were correct and compliant.
- Managed budgets for various departmental initiatives including audits, regular verification and validation product testing and consistent travel support for production facilities.
- Managed a team of 5 direct salaried employees, each with a level of expertise in various pillars to support the growth of the internal food safety programs and culture
- Coordinated recruitment efforts to attract top talent.
Food Safety and Quality Manager
UAS Labs - A Probiotics Company
09.2017 - 04.2019
- Developed and enhanced the Food Safety and Quality Management System for the green space startup fermentation facility.
- Built, developed and lead a team of 13 team members that helped to implement a full microbiological lab, anchored the policies and procedures across the facility teams and developed full cleaning and sanitation procedures for all areas of production.
- Lead all efforts to ensure the newly development strains/products followed regulatory guidelines and successfully tested through all steps of the validation process.
- As production ramped up after startup, developed and executed quality improvement initiatives for reduced defect rates by using available metrics from early production.
- Introduced and trained the facility teams on formal problem solving and initiated the use of the FMEA tool to allow for focused analysis and progress on non-conformances throughout startup and continuous improvement opportunities.
Food Safety, Quality and Regulatory (FSQR) Manager
Cargill Cocoa & Chocolate
02.2016 - 09.2017
- Lead and coordinated efforts to transition the Food Safety Management Management System to meet a new GFSI Scheme after the acquisition of the facility from ADM to Cargill. (SQF to FSSC 22000)
- Streamlined communication processes to foster transparency among departments and lead to more collaborative work across the facility units. This included initiatives to improve training, internal audit system and behavior based analysis and formal trouble shooting activities.
- Managed the annual FSQR budget and lead a diverse team of 16 salaried and non-salaried employees.
Progressive Quality and Regulatory Roles
MillerCoors Brewing Company
07.2005 - 02.2016
- Developed a variety of leadership and compliance related skills while working within the large scale Milwaukee Brewery, the Watertown Hops Plant and 3 craft breweries over the duration.
- Gained significant experience in various roles in both lateral and upwards advancement. These roles across the network included: Microbiology Technician, Quality Brewing Specialist, Packaging Quality Specialist, Training Specialist, Food Safety and Quality Manager which also included several EHS and HR related functions and ended with Craft Supply Chain Quality
- Owned and lead the development of the multiple management systems across the Hops production facility and 3 Craft Breweries.
Education
Masters of Management -
Cardinal Stritch University
Milwaukee12-2009
Bachelor of Science - Molecular Biology
University of Wisconsin - La Crosse
La Crosse12-2000
Skills
- Product lifecycle management
- Domestic and global regulatory compliance
- Cross functional risk management
- Leadership skills and employee life cycle management
- Environmental, Health and Safety management systems
- Facility compliance monitoring
- Full scale audit support
- Project management and change management
- CAPA and formal problem solving
- Critical thinking and decision-making
- Policy implementation
- Legal research
Certification
HACCP Manager Certification - LRQ 2021
PCQI - NSF 2017
SQF Practitioner - AIB 2016
RABQSA Certified 9001:2008 Internal Auditor - AIB 2014
FSSC 22000 Practitioner - AIB 2013
Timeline
Chief Regulatory Officer
American Pasteurization Company, LLC
10.2023 - Current
Manager of Food Safety and Regulatory - Americas
Molson Coors Beverage Company
04.2019 - 10.2023
Food Safety and Quality Manager
UAS Labs - A Probiotics Company
09.2017 - 04.2019
Food Safety, Quality and Regulatory (FSQR) Manager
Cargill Cocoa & Chocolate
02.2016 - 09.2017
Progressive Quality and Regulatory Roles
MillerCoors Brewing Company
07.2005 - 02.2016
HACCP Manager Certification - LRQ 2021
PCQI - NSF 2017
SQF Practitioner - AIB 2016
RABQSA Certified 9001:2008 Internal Auditor - AIB 2014
FSSC 22000 Practitioner - AIB 2013
Masters of Management -
Cardinal Stritch University
Bachelor of Science - Molecular Biology
University of Wisconsin - La Crosse
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