COLLEEN AZURE MOYNA, M.S., CQMOE, PMP

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OBJECTIVE

Obtain a consulting position in Quality Assurance in which I may make a measurable impact implementing new/ improved systems, large-scale changes and/or developing creative and compliant solutions to problems. SUMMARY OF CANDIDACY

• 20 years biomedical experience, the vast majority of which are in Class I-III Medical Device companies with constrained budgets and limited personnel

• Enthusiastic and collaborative management style with a hands-on approach

• Specialty 1: Establishing and revamping Quality Systems as well as making those system electronic via eQMS implementation (Master Control, Grand Avenue, etc.).

• Specialty 2: Managing large-scale projects (tens of thousands of line items) such as for (1) mergers, acquisitions and product licensure agreements, (2) facility transfers, (3) regulation-driven changes (EUMDD to EUMDR, Brexit, MDSAP, UDI, etc.), (4) material changes, (5) global marketing initiatives, (6) consolidation/ obsolescence of redundant documentation and low volume skus, etc.

• Specialty 3: Carry out critical communication outside company such as (1) establishing legal agreements and approved specifications with OEM, Private Label and Contract Manufacturing customers (2) hosting external audits (FDA, California FDA, Notified Body, JPAL, customers), (3) reporting recalls, (4) acting as company liaison and board member with relevant patient-serving non-profit organization. RESULTS

Project ROI well into six figures

2,500+ complaint backlog eliminated in < 9 mo

40K Documents Managed

8 Successful Mergers and Acquisitions

100% improvement in CAPA Effectiveness

99+% training compliance

>95% recalled product reconciliation

58% reduction in NC Age

32% reduction in NCs

25+% complaint rate reduction

EXPERIENCE

Jan 2020-present CEO, Principal Consultant Moyna & Associates

• Provide Quality System Expertise and Project Management/ Execution on a consulting basis for Class I-III Medical Device and Nutraceutical companies.

• Led successful implementation of eQMS across multiple domestic and international sites with tens of team members and serving ~1500 employees. Migrated thousands of labels into labeling software with intelligent back-end capabilities.

• Audits, Gap Assessments, Process Changes for EUMDR, ISO 13485, WEEE Directive, 21 CFR 820, etc.

• Interim Management while client(s) secured permanent candidates.

• Rewrote Quality System documentation for compliance with latest regulations and carried out Internal and Supplier Audits.

Feb 2011-Dec 2020 Sr. Director, Quality Systems SunMed (formerly Salter Labs) Previous Positions Held: Manager- Quality Systems, Manager- CAPA & Post Market Surveillance

• Salter Labs, a manufacturer of Class I-II Respiratory Medical Devices with 25+ product lines and thousands of skus, was purchased by parent company and private equity firm RoundTable in 2010 with the goal of improving systems and selling the company, which was achieved in 2019. This role entailed leading the Quality System improvement efforts towards this objective.

COLLEEN AZURE MOYNA, M.S., CQMOE, PMP

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• Established/ completely revamped Quality Systems: Audit, CAPA, Complaint, Document Control, Management Review, Non-conformance, Recall, Risk Analysis, Quality Control and Training, including spear-heading implementation of eQMS (Grand Avenue) and labeling software with intelligent “back end” capabilities

(Loftware). Built two productive Quality System teams from the ground up at different facilities, including a new satellite facility. Decreased complaint rate by 25+%, enhanced CAPA feeder system breadth by 60%, increased CAPA Effectiveness by 100%, achieved Training Compliance rate of 99+%, and attained >95% product reconciliation on class I-III product recalls. Improved Relationship with Regulatory Bodies by going from system with multiple and/or serious findings (including those inherited in acquisitions) to systems with few/no findings and open, collaborative communication with regulatory bodies. Hosted FDA, California FDA, Notified Body

(MedCert, BSI), JPAL and various customer audits, including audits for facility transfers, Notified Body changes and adding newly acquired products to CE marking.

• Led Numerous Quality System Project Teams toward key company initiatives, including large-scale changes

(tens of thousands of line items):

Eliminated 1) 2500+ complaint backlog in under 9 months with team of three, 2) redundancy in thousands of device master records with team of two, 3) skus with low sales volumes

Migrated 1) 15,000 Quality System documents, tens of thousands of records and numerous processes in eight mergers/ acquisitions and facility transfers with lean teams, 2) 40,000 documents into eQMS system 3) thousands of Bills of Material from paper files to ERP System with one temporary resource.

Edited tens of thousands of documents and hundreds of thousands of labels to 1) reflect regulation- driven changes (EUMDD to EUMDR, Brexit, MDSAP, UDI, etc., 2) add translations for global labeling 3) add local language for manufacturing facility 4) reflect new CE Mark for Notified Body change, 5) modify Legal Manufacturer and Country of Origin for mergers, acquisitions and facility transfers 6) revise declared materials as a result of material changes

• Liaised communication outside company. Designed system for communicating with OEM, Private Label and Contract Manufacturing Customers to establish legal agreements, answer product material questions, and resolve complex customer requirements for specific products. Secured many signed quality agreements using said process. Organized Health Fair for employees, raised thousands of dollars towards non-profit donation and improved company community outreach by acting as company representative and board member of the American Lung Association. Awarded Outstanding Service Award for mobilizing Customer Management System. Personally invited to meet with Roundtable’s Board Chairman to showcase record-setting complaint back-log elimination.

Jan 2008-Feb 2011 Quality Assurance Manager Advanced Bionics Previous Positions Held: Quality Systems Analyst

• Advanced Bionics, a manufacturer of Class III Cochlear Implant Devices, received a warning letter in 2005 and carried out a class I recall of implanted product. This role supported the improvement of Quality Systems towards the goal of FDA lifting the warning letter, which successfully took place in 2010.

• Owned Audit, CAPA, Management Review, Non-conformance Quality Improvement Team, Stop Shipment and Training. Interfaced directly with FDA and Notified Body (TUV) auditors, led all “back room” audit activities and documented detailed records of external audits. Approved Change Orders representing Quality System function. Reduced average CAPA age to 85 days, Non-conformance age by 58% and Non-conformance number by 32%. Honored with Employee of the Quarter Award for Nonconformance and CAPA improvements. Jan 2005-Aug 2007 Research Assistant SALK Institute: Fred Gage Lab Jun 2003-Jun2004 Lab Technician Genentech, Inc.

EDUCATION & CERTIFICATIONS

• M.S. Regulatory Affairs for Drugs, Biologics, & Medical Devices Northeastern University

• B.S. Animal Physiology & Neuroscience University of California, San Diego

• Certified Quality Manager of Operational Excellence ASQ

• Certified Project Management Professional California State University, Bakersfield

• Certificate: Implementation of (EUMDR) Regulation for CE Marking BSI Training Academy

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