Consultant

  (610) 462-4090

  info@qualitysolutionsnow.com

Experienced Senior QA Manager with 20+ years in Quality Assurance and Quality Control in GxP in pharma, biotech, clinical trials, medical device, and Cell and gene Therapy industries. Skilled in ensuring compliance with regulatory standards, Quality Management Systems, deviations, root cause analysis, CAPA, FMEA-Risk Assessment, investigations, change controls, driving continuous improvement, team management, analytical method development, early research and development, validation, and implementing Lean and Six Sigma tools. Certified Change Agent dedicated to delivering cutting-edge therapies while maintaining high quality and regulatory compliance.

CORE COMPETENCIES

  • Quality Risk Management ICH Q9, 21 CFR
  • Regulatory Response to Observations
  • BLA Review and Approval
  • Standard Operating Procedures/Work Instructions
  • Project Management/Collaborative Leadership
  • High-Performance Team Building
  • Process Development/Process Controls
  • Six Sigma, Lean Manufacturing/Laboratories
  • Kaizen, Kata, 5 Whys, 5S, Fault Tree Analysis, Ishikawa Diagram
  • Data Analysis/Trend Reports/Metrics
  • Technical Writing/Protocols/Reports
  • Deviation Management/CAPAs/Root Cause Analysis
  • Quality Systems Auditing/Gap Assessment
  • Sterility Assurance (FDA, EU GMP, 21 CFR)
  • 21 CFR Parts 4/7/210/211/801/803/806/807/810/812/820
  • ICH, ISO 9000/9001, ISO 13485
  • Continuous Process Improvement
  • Analytical Method Development ICH Q2R2, Q6A-Q6B, Q9, Q11, Q14

SELECTED ACCOMPLISHMENTS

  • Inspection Readiness and Product Launch:
    Supported inspection readiness and launch teams for two CAR-T drug products (Abecma and Breyanzi) at Bristol Myers Squibb, ensuring compliance with global cGMP standards and corporate policies.
  • Regulatory and BLA Submission Support:
    Provided quality oversight for clinical and commercial parenteral drug manufacturing, supported BLA regulatory review, and responded to FDA observations, achieving timely product release and regulatory compliance.
  • Cost Savings Through Procedure Improvements:
    Drove operational improvements at Bristol Myers Squibb by implementing streamlined procedures, reducing turn-around times, and achieving cost savings through Six Sigma Lean Labs and FMEA-Risk Assessment for commercial operations.
  • QMS Gap Assessment:
    Completed a 3-year contract at Merck in Luzern, Switzerland, performing a QMS gap assessment for Phase 2 clinical manufacturing of Keytruda, closing over 300 deviations and CAPAs, and preparing the site for FDA commercialization.
  • Leadership in Quality Assurance:
    Recruited, managed, and mentored a team of 6 managers and 45 scientists to support the rapid expansion of operations at Bristol Myers Squibb, driving business continuity planning and maintaining compliance with global quality standards.
  • Process Development and Risk Assessment:
    Led the development of quality management systems and risk assessments for early clinical phase manufacturing at the Gates Biomanufacturing Facility, ensuring compliance and successful project management for multiple clients.

PROFESSIONAL EXPERIENCE

  • Bristol Myers Squibb – Senior Manager Quality Control Microbiology Operations (Jan 2022 – Jul 2024)
  • Bristol Myers Squibb – Senior Manager Quality Assurance Operations (May 2019 – Dec 2021)
  • Gates Biomanufacturing Facility – Quality Assurance Manager (Feb 2016 – Jun 2018)
  • MSD (Switzerland) – Senior Quality Assurance Specialist (Aug 2012 – Jun 2015)
  • Merck – Quality Assurance Specialist (Feb 2011 – Aug 2012)
  • Professional Gap – Family emergency (Jun 2007 – Jan 2011)
  • Amgen – Senior Quality Assurance Associate (contract) (Nov 2006 – Jun 2007)
  • Pharmatech – Program Manager Clinical Trials (Mar 2006 – Nov 2006)
  • Thermo Biostar – Formulations Supervisor (Jan 2004 – Mar 2006)
  • Amgen – Senior Microbiologist (contract) (Jan 2001 – Dec 2003)
  • Procter & Gamble – Senior Microbiologist Program Manager (Sep 1996 – Aug 2000)
  • Professional Gap – Family planning (1993 – Sep 1996)
  • Pace Foods – Microbiologist (Jul 1990 – Dec 1993)
  • Virus Reference Laboratory – Microbiologist (Sep 1987 – Jul 1990)
  • University of Texas Health Science Center – Research Associate (Aug 1982 – Aug 1987)

EDUCATION

  • Master of Science (MS), Organizational Leadership – Colorado State University (Sep 2009 – May 2017)
  • Bachelor of Science (BS), Biology/Chemistry – University of Texas (Aug 1981 – Dec 1992)

CERTIFICATION

  • Certified Change Agent – Merck (Sep 2011)
  • Yellow Belt – Merck (Jan 2012)

TRAINING

  • Root Cause Analysis – Merck (2011)
  • Six Sigma – Merck (2012)
  • Comparative Analysis – Thermo Biostar (Jun 2004)
  • Analytical Method Development
  • Laboratory Information Systems
  • Preparing for ASQ Certification for Quality Auditor

AFFILIATIONS

  • Parenteral Drug Association (PDA) – Jan 2022
  • American Society for Quality (ASQ)