Summary
Work History
Education
Affiliations
Competencies
Overview
Generic

Jason Erickson

Vacaville,CA

Summary

Strategic quality and regulatory leader with 15+ years of experience driving global QMS implementation and regulatory compliance across FDA-regulated, multi-site operations. Recognized for building high-performing teams, leading cross-functional initiatives, and delivering scalable process improvements that enhance audit readiness and operational efficiency.

Work History

Director, Quality and Regulatory Compliance

Thermo Fisher Scientific
07.2022 - Current
  • Build and elevate high-performing talent pipelines by mentoring cross-functional teams and articulating a clear internal value proposition that aligns with individual growth and business objectives.
  • Steer a >$15 million annual operating budget - prioritizing business needs and resource allocations to deliver up to a high of 18% cost savings.
  • Guide the QA/RA organization through complex transformations, safeguarding day-to-day execution and keeping stakeholders focused on long-term strategic targets that drove efficiency increases of 20%.
  • Strengthen process controls to ensure global regulatory compliance, achieving zero major findings in three notified body audits.
  • Champion a culture of engagement and collaboration through targeted recognition, transparent communication, and career-development initiatives, boosting employee engagement results year-over-year to above company average by 10%-15%
  • Embed continuous-improvement by launching a Quality GEMBA program aligned with enterprise process initiatives, driving 10 kaizen events and achieving >40% reduction in deviations, >25% in OOS, and 20% in product nonconformance.

Vice President, Quality Assurance and Regulatory Affairs

Fluidigm Corporation
10.2017 - 07.2022
  • Promoted from Sr. Director, QA/RA in June 2021
  • Led regulatory submissions and launches of two IVD products (2020, 2021), ensuring full compliance with applicable standards and accelerating market entry.
  • Directed cross-functional teams and partnered with senior leadership to execute strategic initiatives, resulting in new product launches, improved efficiency, and customer satisfaction.
  • Built and nurtured strong relationships with regulators, customers, suppliers, and stakeholders to support compliance, collaboration, and business growth.
  • Established a culture of quality and continuous improvement, driving innovation, sustainable operations, and organizational agility.
  • Implemented automated QMS workflows and streamlined processes, increasing productivity and delivering measurable cost savings.
  • Ensured proactive regulatory compliance through robust internal controls, risk-based monitoring, and deep understanding of global regulatory frameworks.

Director of Quality and Regulatory

Expression Systems
04.2015 - 10.2017
  • Set enterprise quality and regulatory strategy for cell-culture media and baculovirus reagent lines, aligning operations with FDA 21 CFR 210/211 and 21 CFR 820 to support growth across pharma, IVD, and academic markets.
  • Led cross-functional QMS governance, providing oversight of CAPA, change control, supplier management, and audit programs; drove a right-first-time culture that reduced deviations and findings.
  • Initiated and executed digital-quality roadmap. Selected, project-managed, and completed full implementation and Computer System Validation (CSV) for a new electronic QMS and equipment asset management system, delivering on schedule and boosting data integrity and audit readiness.
  • Championed risk-based compliance, integrating GxP best practices across manufacturing, QC, and logistics to enhance process capability and shorten release timelines.

Director of Quality

Biosearch Technologies
04.2010 - 04.2015
  • Led all Quality functions (QA, QC, Validation, Engineering, and Metrology) for a global contract manufacturer of oligonucleotides and specialty reagents produced as components of IVD tests.
  • Directed validation strategy and execution for enterprise systems, including internally developed eQMS and Oracle eBusiness Suite, delivering compliant, audit-ready digital infrastructure.
  • Successfully led the company through initial ISO 13485 certification with zero findings, while building high-performing teams and driving a culture of continuous improvement and audit readiness.

QA/QC Supervisor II

Bio-Rad Laboratories
09.2008 - 03.2009

Quality Manager

AcroMetrix Corporation
04.2003 - 09.2008

Education

Master of Science - Biology

University of Nebraska At Kearney
Kearney, NE
05.2009

Bachelor of Science - Biochemistry

University of California, Davis
CA
06.2001

Affiliations

  • Member, American Association for the Advancement of Science (AAAS) 2006 – present
  • Member, American Society for Quality (ASQ) 2006 – present
  • Member, Association for Molecular Pathology 2006 – 2010

Competencies

  • Regulatory Mastery: Deep expertise in 21 CFR 820, MDSAP, ISO 13485, ISO 14971; proficient in interpreting and applying global regulatory standards across product lifecycles
  • Quality Systems Excellence: Leadership in building, scaling, and maintaining robust Quality Management Systems (QMS); strong command of design control, design assurance, V&V, risk management, and lifecycle documentation
  • Audit & Compliance Oversight: Extensive experience leading internal, external, and supplier audits; CAPA management; inspection readiness; and regulatory body engagement (FDA, DEA, Notified Bodies)
  • Strategic & Operational Leadership: Visionary leader with a track record of aligning quality and regulatory strategy with business goals; drives process optimization and compliance culture across matrixed, global organizations
  • Cross-Functional Collaboration: Skilled in cultivating strong partnerships across R&D, manufacturing, regulatory, and executive teams to enable compliant innovation and sustained product quality
  • Data-Driven Decision Making: Champion of continuous improvement through metrics, risk-based approaches, and data analytics for informed, impactful decisions

Overview

22
22
years of professional experience

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