Summary
Work History
Education
Skills
Certification
Languages
Timeline
Generic
ANGELA BAZIGOS

ANGELA BAZIGOS

Menlo Park,CA

Summary

Dynamic Clinical Quality Assurance professional with over 20 years of experience in the pharmaceutical and biotechnology sectors, specializing in global leadership for Quality Management Systems. Extensive expertise includes GCP, GLP, ICH E6 R3, CFR Part 11, and EU Annex 11, complemented by a strong track record in regulatory inspections with agencies such as FDA, EMA, and MHRA. Proven ability to design and implement effective QMS systems while managing vendor relationships and ensuring compliance across outsourced clinical trial models. Results-driven leader dedicated to enhancing clinical trial operations and advancing quality assurance initiatives within global organizations.

Work History

Clinical Investigator Site Quality Assurance Officer (QAO) - (Contract)

Santos Research Center CORP (Clinical Site)
12.2024 - Current
  • Ensure compliance with FDA GCP regulations and ICH E6(R3) guidelines.
  • Ensure compliance with 21 CFR 11 / Computer Systems Validation / Data Integrity.
  • Conduct internal and external audits of clinical trial processes
  • Develop and implement quality management system
  • Monitor clinical trial activities to ensure adherence to protocols and regulatory requirements
  • Identify and manage risks related to clinical quality
  • Host regulatory agency inspections
  • Host third party audits
  • Support Clinical CAPAs
  • Vendor Qualification
  • Vendor Contract Review for compliance with regulatory requirement
  • Computer Systems & Equipment Qualification and Validation

CEO Touchstone Technologies, Inc.

Touchstone Technologies, Inc.
03.2001 - Current
  • Speaker and trainer on diverse topics, including 21 CFR 11, Computer Systems Validation, Data Integrity, and Infrastructure Qualification, both nationally and internationally.
  • Managed and conducted multiple audit projects GCP, GCLP, GLP, 21 CFR 11, Data Integrity, Vendor Qualification, simultaneously, maintaining high standards of accuracy and timeliness.
  • Set up SOPs and Systems for GCP, GCLP, GLP, PV, IT, Data Integrity, QMS, Vendor Management procedures.
  • Enhanced brand reputation for clients with effective marketing actions and public relations efforts.
  • Developed key operational initiatives for clients to drive and maintain substantial business growth.
  • Managed partnerships and strategic business relationships for clients by negotiating contract terms and handling conflicts.
  • Led successful turnaround efforts for clients for underperforming divisions or subsidiaries, restoring profitability within tight timeframes.
  • Drove significant cost reductions while maintaining product quality, negotiating favorable contracts with suppliers, typically reducing supplier cost to 1/3 of initial supplier estimate.
  • Championed data-driven decision-making culture, enhancing business intelligence and strategic planning capabilities.
  • Established and maintained strong relationships with customers, vendors and strategic partners.
  • Managed financial, operational and human resources to optimize business performance.
  • Developed sales and marketing strategies to facilitate business expansion.
  • Analyzed industry trends and tracked competitor activities to inform decision making.
  • Maintained P&L and shouldered corporate fiscal responsibility.
  • Oversaw business-wide changes to modernize procedures and organization.

Subject Matter Expert on Compliance

Touchstone Technologies, Inc.
02.1992 - Current
  • Actively sought out speaking engagements for company executives at conferences or industry panels, leading to increased thought leadership positioning.
  • Created informative whitepapers and case studies showcasing product successes, establishing thought leadership in the industry.
  • Co-authored and prototyped the 21 CFR 11 rule and General Principles of Software Validation with the FDA while at Roche.
  • Working closely with the FDA, I led a team of 30 people in the development of one of the first Computer-Assisted New Drug Applications (CANDA) for the drug Mycophenolate Mofetil at Roche, which enabled the company to obtain an additional $547 million of revenue in the first year. I was double-promoted and received the Chairman's award for that project.
  • Working closely with Oracle while at Roche, I worked on the design and implementation of the first EDC system, Oracle Clinical, as well as the first AE system, AERS. All EDC systems today have the same database schema as Oracle Clinical.
  • At PriceWaterhouseCoopers, I introduced the Rapid Application Development (RAD) methodology, a precursor to the Agile methodology, for the design and implementation of computerized systems.
  • At PriceWaterhouseCoopers, I worked as a project manager at Fox Corporation, managing Fox's global projects, a $34 34million project.
  • At Incyte Genomics, I led the development of ZooSeq, an animal genomic database.
  • At Incyte Genomics, I was tasked with leading a 60-person division to restructure the Clone Transfer Division. Incyte sold subscription databases to Pharmaceutical companies for millions of dollars per year. When the Pharma companies found a promising genomic sequence, they requested this sequence in a bacterial clone that could be used for further research. The Clone Transfer Division achieved a 65% success rate in delivering these $300 clones. The Pharmaceutical companies wanted to stop their subscriptions as they were unable to work on the genomic sequence.
  • For Clone Transfer, I analyzed all the parts of each division, from order management to labs, to clone yield, to invoicing and receiving payment. I restructured all departments and relocated the labs from Palo Alto, CA, to St. Louis, Missouri. I kept the clients informed on our efforts to improve our clone yield. Finally, the clone yield reached 94% and clients no longer wanted to leave. I established preventive measures to ensure that this did not happen again. I was double promoted.
  • At Incyte Genomics, I was tasked with setting up a tissue bank in collaboration with a partner to obtain tissues from cancer patients who had given consent, allowing Incyte to utilize them for sequencing. I set up the tissue bank at the Children's hospital in LA, and developed an EHR type database, based on my knowledge of Oracle Clinical, to keep track of the tissues. The project was successful, and later Incyte Genomics sold the EHR database to EPIC.
  • At Incyte Genomics, I observed that various departments were experiencing productivity losses and incurring additional costs, as the homegrown systems they were using could not scale with the company. I proposed a complete systems reset to Senior Management, where an ERP would replace homegrown systems. I led the team in designing the architecture of the new systems (comprising 30 people) and oversaw the design and implementation of all 16 systems. 15 out of 16 systems were delivered on time and on budget.
  • At Touchstone Technologies, Inc., I coauthored the book "Computerized Systems for Clinical Research" with FDA and DIA (2011) and coauthored the book Data Integrity (2025) with SQA.
  • At Touchstone Technologies, Inc. I held leadership positions at Pacific Regional Chapter of Society of Quality Assurance (PRCSQA), including the position of President. As President, I was one of the first people to invite the FDA to present at an industry conference, using Dr. Chrissy Cochran (Head of OBIMO) as one of the first FDA presenters.
  • At Society of Quality Assurance (SQA), I led an effort to have FDA and Industry work more closely together, by co-presenting at a conference with FDA "The Patient Will See You Now", with Captain Jane Kreis of FDA (Public Health).
  • At SQA, when COVID started, I wrote a paper encouraging remote audits and explaining how to set them up. The FDA has taken this to Congress, and both the FDA and industry are using more and more remote methods for inspections and audits
  • At SQA, I presented on vendor qualification of CROs to the Clinical Subspecialty section, with FDA's Dr. Chrissy Cochran providing oversight for the session.
  • At SQA, I commented on various guidance documents, including CAR-T Cell Therapy, where I pointed out that CAR-T was very similar to tissue transplant, and the FDA should consider guarding against Graft vs Host Disease when CAR-T cells are infused into the patient. I presented this to the Clinical Subspecialty at SQA.
  • At SQA, I co-presented GCP and GLP QA for Gene Therapy with FDA's Dr. Chrissy Cochran and Mr. Eric Pittman.
  • At SQA, I presented an Artificial Intelligence Primer to the FDA and encouraged them to regulate it. Recently, the FDA published 2 guidance documents for AI, one for Pharma and one for Medical Devices, and I commented on both of them.
  • At SQA, I am presenting Clinical Quality Assurance for Medical Devices, to the Medical Devices Subspecialty, at the end of October 2025.

GCP Auditor (Contract)

Kezar Life Sciences
08.2024 - 02.2025
  • Forensic GCP Audit of Philippine clinical sites to determine potential cause of death in Lupus Nephritis patients.
  • Reported to Executive Committee.
  • Contributed to Board Presentations

IT & GCP Auditor, IT QA & Head of Clinical Data Mgmt (Contract)

Huntington Study Group (HSG)
07.2022 - 05.2024
  • Vendor Qualification of CRO both for GCP and IT Systems.
  • Took over as Program Management as Global Head of Clinical Data Management when CRO failed to execute on tasks.
  • Reported to Executive Committee.
  • Led team to deliver Study Database on time for FDA submission.
  • IT QA.

Validation and Quality Consultant (Contract)

Various, Menlo Park, CA
02.2021 - 07.2022
  • GCP, GLP, GCLP, CLIA, GMP, PV Audits / SOPs and Systems and Processes Implementation
  • Validation and Infrastructure Audits and Validation Remediation.
  • GCP, GLP, GCLP, CLIA, GMP, PV local and global QMS vendor selection and implementation.
  • Quality Plans, SOPs, Internal and External Audits, CAPA, Vendor Selection and Management.
  • Pharma, Biotech, Medical Devices, Gene Therapy.
  • FDA, EMA, MHRA, NMPD, PMDA.
  • Proven ability to learn quickly and adapt to new situations.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Passionate about learning and committed to continual improvement.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Organized and detail-oriented with a strong work ethic.

GCP Auditor, (Contract)

Pfizer
10.2019 - 01.2021
  • GCP Audits of Clinical Sites for the development of the Pfizer Covid-19 Vaccine.
  • Adult and pediatric studies

GCP / GLP / GCLP / Data Integrity Auditor (Contract)

Various, Menlo Park, CA
10.2019 - 01.2021
  • GLP / GCP / Data Integrity Audits, SOPs, Systems & Processes

Acting CEO as Representative to FDA (Contract)

PMI Services, GLP and non-GLP CRO
02.2012 - 10.2019
  • Company had been recently acquired by FocusMG but then received a GLP related Warning Letter from FDA which caused the CEO to resign.
  • This resulted in Warning Letter going unanswered for the entire response period and company was at risk of a consent decree.
  • Acquiring company hired me to take over from CEO role for the remediation of the Warning Letter.
  • Negotiated with FDA to extend the response time and explained I would be representing the company in the place of the CEO.
  • Represented PMI Services to FDA for all subsequent communications with FDA. Specifically worked with Dr. Chrissy Cochran at FDA, who is currently the head of OBIMO at FDA.
  • Warning Letter was resolved successfully and FDA re-inspection was successful.
  • Subsequently invited Dr. Cochran to present at SQA conference that I was hosting and have co-presented with her and other members of OBIMO at SQA Conferences such as QA for Gene Therapy.
  • Presented AI in LifeSciences to Dr. Cochran and other OBIMO members so FDA would start regulating AI.
  • Commented on new FDA guidance documents on AI for Pharma / Biotech and AI for Medical Devices
  • Reported to Executive Committee.

Quality Consultant (Contract)

Baylor College of Medicine
06.2018 - 04.2019
  • College Department had lost College of American Pathologists (CAP) license due to compliance violations
  • Assessed existing processes and compliance and implemented remediation.
  • Created new SOPs or replaced existing SOPs that were out of date or incorrect for both CAP and GLP.
  • Hosted inspection for CAP and CAP license was restored.

Chief Compliance Officer (Contract)

Reprosouce (acquired by Quest Diagnostics)
05.2017 - 02.2019
  • Prepared company for Audit and Remediation in preparation for FDA inspection.
  • GCLP, GMP.
  • Hosted successful inspection.
  • Validated LIS and other systems.
  • Key Member of the Leadership Team providing strategic insights on clinical and manufacturing quality related matters impacting development, regulatory submissions, and commercialization.
  • Created GMP SOPs for acquisition partner.
  • Reported to Executive Committee.
  • Successfully handed off to acquisition partner

Chief Compliance Officer and Head of Life Sciences

Morf Media
04.2015 - 04.2017
  • Established QA strategy for worldwide deployment of app
  • Proposed app strategy resulting in hiring resources in India for completion of app
  • Customer acquisition including major players in the LifeSciences training space
  • Project Managed final rollout of the desktop software that powered the app
  • Annual budget planning, forecasting and budget management for operational systems; oversight of system investment budget for build and run/support activities.
  • Defined and tracked value realization for system investments across operational systems.
  • Presented to the Board
  • Pitched to Investors for funding
  • Interviewed by Wall Street Journal on training for Life Sciences Boards Using Training to Bring Compliance to Boardrooms - https://www.wsj.com/articles/BL-252B-7659?mod=skd=0e4a9294ab7c6dcc1bd7875caa226c01
  • Hosted a Medical Device Conference that included training for Boards of Life Sciences Companies
  • Key Member of the Leadership Team providing strategic insights on quality related matters impacting development, regulatory submissions, and commercialization
  • Https://www.businesswire.com/news/home/20150409005147/en/Morf-Media-Inc-Appoints-Angela-Bazigos-as-Chief-Compliance-Officer-and-Head-of-Life-Sciences-Business-20491830/

Chief Compliance Officer

Prime Genomics (now NowDx)
11.2014 - 02.2016
  • Led compliance strategy development to align with regulatory requirements and organizational goals.
  • Advised senior leadership on strategic initiatives from a compliance perspective, ensuring alignment with organizational values and objectives.
  • Collaborated with legal, accounting and other professional teams to review and maintain compliance with regulations.
  • Established vendor selection and management and reviewed vendors including Mayo Clinic
  • Worked with FDA to set up clinical trials at Travis Air Force Base
  • Reviewed UCSF Breast Cancer Department for clinical trials partnership
  • Key Member of the Leadership Team providing strategic insights on clinical quality related matters impacting development, regulatory submissions, and commercialization
  • Successfully handed off to acquisition partner, NowDx. Syphilis diagnostic test was approved by FDA on 19Aug2024 https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis
  • Reported to Board.

Acting QA Director (Contract)

Counsyl
05.2011 - 02.2012
  • Led first inspection of facility by College of American Pathologists (CAP) for CAP certification.
  • Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
  • Proactively identified potential risks and implemented mitigation strategies to minimize negative impacts on projects or business operations.
  • Strengthened internal controls by reviewing existing policies and procedures, ensuring compliance with regulatory requirements.
  • Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
  • Led delivery on requirements for a successful CAP certification inspection.
  • CAP inspection result was spectacularly amazing, with only 2 easily remediated findings, as opposed to hundreds of findings that inspectors would normally find in first inspection of a facility. Certification followed shortly after.

Validation Project Manager (Contract)

Veracyte
07.2010 - 04.2011
  • In Vitro Diagnostics Multi Index Assay (IVDMIA) Software Development and Validation Project Manager, CLIA, IT Compliance, IVDMIA Medical Device Submission, Genomic Thyroid Cancer Detection; ISO 13485, ISO 14971
  • Identified plans and resources required to meet project goals and objectives.
  • Mentored other team members to comply with ISO 13485 and ISO 14971, fostering professional growth and improving team performance.
  • Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
  • Monitored project performance to identify areas of improvement and make adjustments.
  • Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
  • Provided detailed technical and operational direction in project challenges, consistently meeting deliverables according to deadlines.
  • Provided detailed project status updates to stakeholders and executive management.
  • Project was delivered on time for submission to FDA.
  • Assisted with submission to FDA.

Global Strategy Consultant (Contract) - IT Dept.

Novartis Vaccines and Diagnostics
01.2010 - 07.2010
  • Novartis lost revenue on vaccines the previous year because it could not produce enough vaccine volume to keep up with demand.
  • Contributed to Root Cause Analysis which showed globally aging infrastructure and variable data center vendors to be the core issue.
  • Novartis had planned $200,000 for the US project but I estimated at $4.5million, for US project, with a $5,750,000 cost savings over 5 years, resulting in a $1.25 million savings over 5 years (US only).
  • Analyzed market trends and competitive landscape to inform strategic decision-making processes.
  • Conducted thorough risk assessments, mitigating potential issues before they impacted project success.
  • Presented findings and recommendations to senior management, influencing decision-making processes.
  • Collaborated with executive leadership teams to define long-term organizational goals and develop strategic roadmaps to achieve them.
  • Utilized data visualization techniques to present and explain complex data sets.
  • Created dashboards to monitor and track key performance indicators.
  • Set up preventive measures to avoid future revenue loss from infrastructure failings.
  • Strategy virtualized and validated every GxP system for every country while complying with domestic and international regulations (FDA, EMA, MHRA, NMPA, PMDA), so new infrastructure and
  • Strategy delivered on time / on budget.
  • Trained internal personnel and successfully transitioned implementation to internal personnel.

Validation Project Manager (Contract)

Theorem (formerly Clinimetrics)
06.2008 - 06.2010
  • EDC, Safety, Thesauri (WHODrug, MedDRA), and safety data migration projects were 2.5 years behind schedule.
  • Analyzed project plans to determine root cause and recast timelines and budgets.
  • Created and headed up PMO to manage the portfolio of projects across all departments.
  • Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
  • Developed comprehensive project plans, outlining scope, resources, and timelines to guide execution.
  • Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
  • Implemented project management methodologies to enhance efficiency and effectiveness across initiatives.
  • Analyzed risks and developed mitigation strategies to minimize project disruptions and delays.
  • Streamlined communication processes among departments, enhancing collaboration and information sharing.
  • Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
  • Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
  • Delivered on time on budget for recast time / budget goals.

Education

Bachelor of Science - Microbiology with Biochemistry

University of Reading
Reading, UK
06-1981

Master of Science - Computing - specialized in Business Analysis & AI

North Staffordshire University
North Staffordshire, UK
06-1987

Skills

  • Strategic Planning
  • Interfacing with FDA and Other Regulatory Authorities
  • Program and Project Management
  • Quality Assurance
  • Performance metrics
  • Electronic data capture
  • Good clinical practice
  • Good Laboratory Practice
  • Regulatory compliance

Certification

  • Medical Laboratory Scientific Officer (MLSO) NHS, England, UK
  • Accredited GCP Auditor Roche, Palo Alto
  • Project Management PriceWaterhouseCoopers, San Francisco
  • Business Analysis for Computerized Systems PriceWaterhouseCoopers, San Francisco

Languages

English
Full Professional
Greek
Native or Bilingual
Italian
Limited Working
Spanish
Elementary
French
Elementary

Timeline

Clinical Investigator Site Quality Assurance Officer (QAO) - (Contract)

Santos Research Center CORP (Clinical Site)
12.2024 - Current

GCP Auditor (Contract)

Kezar Life Sciences
08.2024 - 02.2025

IT & GCP Auditor, IT QA & Head of Clinical Data Mgmt (Contract)

Huntington Study Group (HSG)
07.2022 - 05.2024

Validation and Quality Consultant (Contract)

Various, Menlo Park, CA
02.2021 - 07.2022

GCP Auditor, (Contract)

Pfizer
10.2019 - 01.2021

GCP / GLP / GCLP / Data Integrity Auditor (Contract)

Various, Menlo Park, CA
10.2019 - 01.2021

Quality Consultant (Contract)

Baylor College of Medicine
06.2018 - 04.2019

Chief Compliance Officer (Contract)

Reprosouce (acquired by Quest Diagnostics)
05.2017 - 02.2019

Chief Compliance Officer and Head of Life Sciences

Morf Media
04.2015 - 04.2017

Chief Compliance Officer

Prime Genomics (now NowDx)
11.2014 - 02.2016

Acting CEO as Representative to FDA (Contract)

PMI Services, GLP and non-GLP CRO
02.2012 - 10.2019

Acting QA Director (Contract)

Counsyl
05.2011 - 02.2012

Validation Project Manager (Contract)

Veracyte
07.2010 - 04.2011

Global Strategy Consultant (Contract) - IT Dept.

Novartis Vaccines and Diagnostics
01.2010 - 07.2010

Validation Project Manager (Contract)

Theorem (formerly Clinimetrics)
06.2008 - 06.2010

CEO Touchstone Technologies, Inc.

Touchstone Technologies, Inc.
03.2001 - Current

Subject Matter Expert on Compliance

Touchstone Technologies, Inc.
02.1992 - Current

Bachelor of Science - Microbiology with Biochemistry

University of Reading

Master of Science - Computing - specialized in Business Analysis & AI

North Staffordshire University

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