FDA QA and compliance consultant for the medical device and IVD industry

Great startup company that I'm helping to prepare for certification to ISO 13485:2016.

World’s Leading Provider of Genomic-Based Tests for Personalizing Cancer CareOur Mission: To transform treatment decisions and outcomes in cancer by delivering clinically actionable diagnostics and services for patients.Our Vision: To revolutionize the treatment of cancer throughout the patient journey.Genomic Health is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from diagnosis to treatment selection and monitoring. Founded in 2000, Genomic Health is committed to improving the quality of cancer treatment decision making through the research, development and commercialization of genomic-based clinical laboratory services. The company conducts sophisticated genomic research to develop clinically validated molecular diagnostic tests that provide individualized information on the likelihood of cancer disease recurrence, and — in some cases — response to certain types of therapy. Genomic Health developed and follows a highly specialized process that adheres to applicable global regulations and standards, including CLIA (Clinical Laboratory Improvement Amendments) regulations and CAP (College of American Pathologists) in the U.S. to deliver the highest standards of quality and proficiency testing.

Managed GMP support activities for the Life Technologies group of Thermo Fisher Scientific. Performed QS audits at GMP sites providing feedback to local and global management. Worked with local QA teams to address findings from FDA audits. Provided updates to global management on progress.Managed QA teams at multiple business locations. Worked with local QA teams to address audit findings (ISO and FDA) as well as observations from customer audits. Provided monthly updates to senior management. Attended global management review meetings providing updates on various projects as needed.

• Prepared Quality sections for regulatory submissions (510k, Canada, CE); reviewed regulatory submissions providing feedback to Regulatory Affairs department• Provided responses to US FDA regarding submissions• Reviewed Regulatory Affairs policies and procedures as needed• Primary contact with the U.S. Food and Drug Administration for compliance activities including inspections, product recalls, and MDRs• Member of the corporate strategic planning executive team• Spearheaded quality system continuous improvement projects for Cepheid’s domestic and foreign manufacturing facilities• Played a pivotal role in product troubleshooting activities; ensured proper documentation of failure investigations and corrective actions (CAPAs); reported compliance metrics to senior management on a monthly basis (CAPAs, Customer complaints, Product issues, updates on FDA and ISO inspections)• Member of new product development teams• Performed internal company quality system audits; member of supplier audit team

• Provided and reviewed Quality sections for regulatory submissions (PMA, Canada, CE)• Facilitated the implementation of quality processes and systems including corporate wide software upgrades and tools• Facilitated quality system training events and activities for company-wide operations• Managed interactions with the U.S. Food and Drug Administration and ISO auditors (inspections, recalls, MDRs)• Ensured compliance with corporate quality systems and procedures that included document control, customer complaint records, internal and external audit programs, product vigilance reporting, validation of business software systems and employee training records

• Provided Manufacturing section of Modular PMA submission for BLN assay; provided responses to Regulatory Affairs regarding questions from FDA on submission• Played a central role in a GeneSearch Breast Lymph Node project and PMA submission ensuring validation lots and IUO clinical trial lots were manufactured per timeline requirements; coordinated manufacturing activities with third party suppliers• Spearheaded the successful move of manufacturing and quality control operations to a new facility• Identified key sources of variability for GeneSearch products working with the research and development groups and assisted external suppliers with the integration of new quality control policies and procedures to ensure product reliability• Revised operational site manufacturing and quality control policies and procedures; identified, audited and negotiated supply and service agreements with key suppliers of critical raw materials and external quality control test labs• Streamlined commercial product and development operations and cross-trained scientists to integrate Cellsearch and Genesearch quality control departments into a single team• Initiated process improvement activities with new product research and development and quality assurance groups to reduce the time to the clinical trial milestone for key product projects without sacrificing quality, cost and compliance• Facilitated developing a health, safety and environmental program for Veridex

Managed quality systems for the North American DNA sequencing and life science research reagent manufacturing operations. Led manufacturing management and audit steering committee teams ensuring sites maintained ISO certification in addition to standardizing quality policies and procedures across global manufacturing facilities.