Quality Assurance Regulatory Compliance

Amerigo A. Pennoni

*** ******** **. #****, ***********, SC 29486 • 484-***-****

*******.*******@*******.*** • www.linkedin.com/in/amerigopennoni

SUMMARY

A strategic and accomplished quality and compliance manager with demonstrated success in quality system oversight, risk management, regulatory compliance, and sustainability. Comprehensive background in tactical leadership within food production, dietary supplements, and CPG industries. Excels at building and leading top-performing teams. Strong working knowledge of manufacturing/laboratory GXPs, quality systems, LCA, supply chain management, and regulatory requirements (including FDA/Health Canada, US/EU Organic Programs, NGP, MSC/RFM, Gluten Free, Vegan, Cruelty Free, and Sport). Proven ability to deliver forward-thinking solutions that improve compliance and mitigate risk.

Regulatory Compliance • Quality Systems Management/Implementation • Internal & External Auditing

cGMP Compliance • Root Cause Analysis • Material/Supplier Qualification • Foreign Supplier Verification •

Food Defense Strategy •Food Safety Plans • Project Management

EXPERIENCE

THORNE RESEARCH Summerville, SC

Quality Assurance Specialists III 2023-2024

Successfully delivered quality assurance initiatives to improve customer satisfaction and reduce customer complaints. Developed and conducted gap analysis to ensure production operations and quality control laboratory operations met regulatory requirements for TGA PIC/s 009-126. Collaborated with multidisciplinary teams to develop and implement standard operating procedures to ensure compliance with applicable regulations. Reviewed quality systems and conducted audits to identify opportunities to improve operational efficiency and improved cost reduction. Reported on quality metrics and closeout of findings to management.

NEW CHAPTER Brattleboro, Vermont

Director, Compliance & Sustainability 2018-2022

Reported to VP of quality on matters pertaining to quality assurance, quality control, risk management, and regulatory compliance. Developed and improved site cGMP compliance-related work processes, including document control, deviations, quality investigations, CAPA program, material review, and change control. Led quarterly reviews of consumer complaints, adverse event reporting, and equipment calibrations. Maintained product traceability with regards to trade returns. Performed quarterly mock market withdrawals, drafted approval for international distribution, and led internal/external audits. Reported to Chief Science Officer, VP of Operations, and VP of Human Resources on all internal sustainability/CSR programs including responsible sourcing, waste/carbon management, philanthropy, B Corp, and employee wellness programs.

Quality Assurance:

Completed more than 30 internal/external audits including regulatory inspections (FDA, USDA, and NNHPD) and certification audits (NSF, GMP, GF, Sport, USDA NOP, NGP, MSC/RFM).

Deployed site-wide eQMS system (VEEVA) on target automating processes involving internal QA/QC, EMQA (External Manufacturing), and ESS QA (External Supply Solutions) operations, delivering overall process improvement and cost efficiency.

oSpearheaded eQMS project roll-out including contract negotiation, module design, UAT testing, system implementation, validation, and employee training.

oEnsured successful transition of change control and record management systems into eQMS, maintaining required documentation of product specifications and standards.

oSuccessfully grew internal reporting capabilities, increasing identification and traceability of quality events.

Managed site registrations for US Food and Drug Administration and CA Natural and Non-prescription Health Products Directorate.

oSupported oversight of product certification programs including US NOP, NSF Gluten Free and Sport, Non-GMO Project Verification, OU Kosher, and ASMI Responsible Fisheries.

oApplied in-depth knowledge of industry trends to provide insight to executive leadership regarding opportunity for new innovations and expansion.

Sustainability:

Maintained sustainability programs and site certifications including B Corp, Ethical Sourcing, ZMTL, USDA Organic, and Non-GMO.

oIncreased number of certified Organic and MWO products.

oIntegrated social responsibility and environmental sustainability into everyday business practice and decision making.

Ensured adherence to company’s green purchasing policy.

oLed ongoing management of company’s Responsible Sourcing Program.

oAdministered supplier assessments to contracted manufacturing sites, component/raw material suppliers.

oIssued SCARS and tracked performance against KPIs/targets for continuous improvement.

Led company CSR programs including philanthropy, green team, and employee wellness programs.

Served as company representative for Vermont Businesses for Social Responsibility (VBSR) and the Organic Trade Association (OTA). Served as member of The Sustainability Committee for the American Herbal Products Association (AHPA) and advisor for American Botanical Council (ABC).

NEW CHAPTER Brattleboro, Vermont

Assistant Director, QA Compliance and Risk Management 2016-2018

Provided support for greater quality organization regarding regulatory compliance, risk assessment, and risk management. Administered site’s Quality Incident System, tracking to completion operational occurrences including planned/unplanned deviations, quality investigations, non-conformances, out of specifications (OOS), and material review. Provided technical support with vendor returns, reprocessing/rework, and material destruction. Tracked and investigated product quality complaints and adverse events. Presented quarterly presentations to operational lead team and supported internal/external audit functions.

90% close out of ongoing open CAPAs and third-party GMP audit findings.

Supported creation and implementation of internal quality audit program.

Designed and implemented Responsible Sourcing pilot program with key Tier I suppliers.

ADDITIONAL EXPERIENCE

NEW CHAPTER, Brattleboro, Vermont, Manager of QA Compliance and Risk Management; Consumer Support Lead 2014-2016

UNITED NATURAL FOODS, Chesterfield, New Hampshire, Customer Engagement Lead; Claims Representative 2012-2014

EDUCATION

ANTIOCH UNIVERSITY NEW ENGLAND, Keene, New Hampshire – M.S., Resource Management and Conservation, 2018

KEENE STATE COLLEGE, Keene, New Hampshire – B.S., Environmental Science, 2008

CERTIFICATIONS & TRAINING

PCQI/FSMA/GMP/Internal Auditing

COMPUTER SKILLS

Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams, SharePoint), eQMS Veeva/ETQ, Trackwise, Google Drive/Dropbox, Navision/SAP

Contact this candidate