Joseph Metro

Martinez, CA *****

Quality Systems Professional

Experienced Quality Lead/Manager with a background in management and leadership. Strong understanding of quality,

operations, and corporate management. Ambitious leader that is committed to patient safety, innovation, and growth.

Leadership

Integrity

Quality

Streamline Operations

Corporate Management

Business Operations

Performance Improvement

Change Management

Core Competencies:

Ability to establish credibility in recognizing/supporting overall organization preferences and priorities.

Strong capability to support change management, business process excellence, and both organization and personnel development in high performance scenarios.

Extensive knowledge with QA/QC requirements within FDA regulated medical and pharmaceutical environments (Class I/II), including CE Mark, CMDCAS, MDD and MDR.

Leadership capability to accelerate performance of people individually or in a team environment.

Effective execution of post market surveillance investigation and data monitoring activities, including forward-facing customer/patient communications.

Strong, result driven customer-focused development of department performance/culture.

Extensive knowledge and background in Business Operating System (including Quality Management Systems) development and Project Management.

Process/product expertise in several industries: chemical separation, electrophoresis, reagents, microbial testing, and sterilization.

Education/Certifications:

John F. Kennedy University

Master of Business Administration (M.B.A.), Management

University of Maryland, Eastern Shore

Bachelor of Science (B.S.), Chemistry,

Attended- Howard University School of Dentistry

Former ASQ Certified Quality Auditor (CQA)

Professional Experience:

Aziyo Biologics, Inc. Richmond, CA September 2022 – March 2023

Director, Quality and Regulatory Affairs

Responsible for leading the Quality Assurance, Quality Control, Donor Services and Regulatory Affairs teams at Richmond’s tissue regenerative processing site.

Revised Quality System complaints, CAPAs, and nonconformance processes and procedures to align with 21CRF Part 1271 requirements.

Resolved all aging CAPAs and Deviations.

Developed quality function metrics while analyzing performance metrics for all departments to identify trends and appropriate actions to remedy.

Successfully conducted third-party audits with zero critical findings.

Successfully defended quality systems during American Association of Tissue Banks (AATB) inspection, resulting in only two findings and zero critical issues reported.

BioSig Technologies Inc. Los Angeles, CA February 2021 – September 2022

Quality Assurance Manager

Deputy Quality Representative Accountable for customer complaints, CAPA/NCs, facilities operations, internal and external audits for a medical device company’s Quality Systems.

Transitioned a completely new Quality System structure including new quality policies and procedures.

Scheduled key stakeholder meetings, and tracked and reported project metrics during executive stakeholder meetings. Developed quality function metrics while analyzing performance metrics for all departments to identify trends and appropriate actions to remedy.

Complied with Company QS process by scoping and executing cross-functional activities.

Resource Logistics, Inc. Remote Location October 2020 – February 2021

Project Manager (HCL/Abbott)

Contracted Project Manager for biotech company’s global product rebranding initiative. Interfaced and supported the development of project deliverables to implement product packaging design including

marketing and regulatory requirements, assigned workflow tasks and resources, developed cost benefit factors for concept selection, worked with suppliers to build prototypes, scheduled and facilitated all team activities and working sessions domestically and internationally.

Implemented, tracked via MS Project, and delivered task assignments. Scheduled key stakeholder meetings, and tracked and reported project metrics during executive stakeholder meetings.

Monitored all performance workflows for design, quality and QS objectives through personal engagement/collaboration with Operations, R&D, Marketing, and Regulatory.

FRESENIUS MEDICAL CARE, NORTH AMERICA Concord, CA October 2013 – June 2020

Quality Systems Manager

Fully accountable for Quality System (QS) performance including Product Quality Engineering, Document Control/Records, Training, CAPA, and Calibration/Metrology, managing multiple cost centers and over 20 employees.

Continuously exceeded performance for both product quality and QS objectives through personal engagement/collaboration with Operations, R&D, Marketing, and Technical Service.

Ensured effective /efficient QS process by scoping and executing cross-functional activities.

Reduced multiple site processes to a single global harmonized operation, including recommendation on capital expenditures through strategic training and change control programs.

Maintained a highly effective/talented organization and improved bench strength through both active performance management and personnel development activities.

Quality CAPA Engineer Contract April 2013 – October 2013

Ensured company remediation of CAPA/NC/Deviation program activities with focused involvement in CAPA investigations, corrective actions, and monitoring of quality data.

Ensured compliance to process requirements and consistency through thorough root cause investigations, and implementation of corrective and preventive actions, and monitoring of data to ensure effectiveness.

Eliminated $200K costs of product byproduct waste by designing DME return decontamination process flow.

Collaborated with Quality Engineering, R&D, and Manufacturing to provide project direction and evaluation of process and design improvements. This includes review and revisions to FMEAs.

Reported and implemented controls to reduce complaints associated with machine noise complaints, and developed visual inspection controls/tests to ensure product and systems conformance to 21CFR820 GMP and ISO13485 requirements.

ONYX PHARMACEUTICALS South San Francisco, CA July 2012 – April 2013

Manager, Quality Assurance Compliance

Managed the Internal and External Audit programs ensuring compliance to FDA 21CFR210/211.

Maintained supplier and contract manufacturer performance by performing compliance audits and evaluation of nonconformances issued. Cross-functional team member responsible for supplier program improvement of the audit tracking database.

Provide extensive end-user input on implementation of audit data and design of data system.

Responsible for the selection, evaluation, monitoring/control, and reevaluation of suppliers. This includes development and execution of an auditing schedule to ensure critical suppliers comply with quality/regulatory requirements and international standards.

GAME READY (COOL SYSTEMS, INC) Concord, CA May 2009 – July 2012

Quality Systems Manager

Provided strategy leadership and deployment execution expertise to combine business and quality operating/management systems for Class II medical and non-medical accessories.

Collaborated with R&D to realize $500K in COGS savings through design temperature control enhancements, and resulting in issuance of U.S. Patent No. US 8,715,330 B2

Direct implementation and maintenance of quality performance metrics in support of data-driven decisions and prioritization of resources.

Developed company quality SOP’s, conducted supplier training, and provided significant instruction/involvement in the development of medical device design improvements to assist the company in meeting regulatory/customer requirements.

Managed the development and implementation of the CAPA program, resulting in 80% reduction of open investigations over 30 days. Implemented risk-based approach to processes

Senior Compliance Associate May 2008 – May 2009

Designed and implemented an effective quality system trending program to monitor key performance metrics, resulting in early detection and mitigation of adverse business/system trends.

Developed a CAPA program, resulting in 80% reduction of open investigations over 30 days. Implemented risk-based approach to processes resulting in a significant reduction of external regulatory observations.

Implemented an eDMR account for device reporting.

Redesigned the Complaint handling system to ensure proper classification and intake information is compliant and categorized correctly.

Person-In-Plant at contract manufacturers to assure compliance to Class II requirements, and QMS operations.

NOVARTIS, (fma CHIRON, CORPORATION) Emeryville, CA March 2005 – May 2008

Compliance Associate

Coordinated multiple departments to integrate prior Chiron processes to Novartis standards, including; Revise/implement supplier management system and global SOPs. Compile, maintain, and present on audit and supplier key performance indicators.

Selected on global audit team to assess company’s Liverpool, England flu vaccine operations post global flu vaccine shortage.

Led internal ISO/IVDD/21CFR Parts 210/211, Canadian and EU GMPs audits of supply chain, pharmacovigilance, regulatory, clinical, purification/sterilization, and analytical operations.

CHIRON, CORPORATION Emeryville, CA March 2000 – March 2005

Corporate Regulatory Associate. January 2003 – March 2005

Support audit programs for Class 3 IVD immunoassay test kit components and equipment. ASQ Certified Quality Auditor responsible for leading corporate internal ISO/cGMP audits of fermentation, sterilization, packaging, and testing operations.

Effectively coordinated and supported regulatory inspections.

QC Supervisor March 2000 – January 2003

Lead staff of seven QC Analysts in GMP testing methodologies associated with the release of commercial drug product raw materials. Revised department procedures and test methods.

Ensure GLP processes and trained Analytical teams.

Led dock-to-stock process improvement initiative resulting in laboratory lead time improvements.

Compliance review and release of LIMS analytical test device history records (DHRs) in accordance to USP, EP, JP, and ACS method requirements.

BIO-RAD LABORATORIES Richmond, CA May 1990– March 2000

QA Specialist January 1997 – March 2000

Responsible to lead internal audits and host customer audits. Organized and facilitated opening and closing meetings. Addressed and closed corrective actions. Review, revise, and approve quality protocols. Review LIMS for final disposition.

Product Team Leader/Facilitator - Led cross-functional operations accountable for $1.5M ion exchange separation processes from forecasting raw materials throughout manufacturing and delivery. Results include a 5% cycle-time reduction, reduced inventories, while reducing back-orders from 10% to zero.

Senior Chemist May 1990 – January 1997

Perform analytical testing utilizing FTIR, UV-VIS, GC spectrophotometers, HPLC, and gel electrophoresis methodologies.

Developed GC method for reliable alcohol residuals from chromatography resin residue processing.

Provide analytical testing support through development of FTIR profiling for corporate marketing, GC test methods for R&D’s monomers, and process impurity profiles for Chemical Development database.

UNION OIL COMPANY OF CALIFORNIA Rodeo, CA November 1987 – May 1990

Analytical Chemist

Perform analytical testing utilizing ICP, AA/HGA methodologies.

Responsible for collecting and reporting California State Laboratory Testing reports.

Developed test method for analysis of Total Nitrogen content in light petroleum hydrocarbons.

Patent

U.S. Patent No. US 8,715,330 B2: Temperature and Flow Control Methods in a Thermal Therapy Device, Lowe et al., May 6, 2014

Volunteer Affiliations

2018- Current: Commissioner, 5th District, Contra Costa County Mental Health Service

Contact this candidate