Emeryville, California 94608
SENIOR-LEVEL QUALITY CONTROL MANAGER
Hands-on operational leader with extensive experience directing the end-to-end quality control process for major
biochemistry laboratories and for the massive incoming raw materials section for global Bayer Healthcare’s
biological products division. Quality, testing, sampling, and inspections expert with advanced knowledge of
cGMP as well as global regulations and specifications for quality control measures. Motivational manager skilled
at turning around under-performing operations with a dedicated commitment to driving continuous improvement
and the institution of operational best practices. Areas of expertise:
Quality Control Laboratory Management Incoming Materials Inspection
Immunology Electrophoresis Potency Chemistry
Current Good Manufacturing Practices (cGMP) Documentation Project Management
Performance Improvement Metrics Development & Achievement Strategic Planning
Managerial Leadership Team Building Cross-Functional Collaboration
BAYER HEALTHCARE, Berkeley, California 2002-Present
Global pharmaceutical corporation. Berkeley site is headquarters of the Biological Products division.
Senior Manager of Quality Control, Incoming Materials Inspection (2009-Present)
Promoted to head a 10-member team and a $3M operating budget in the stringent evaluation of all Quality
Managed materials critical to the manufacture of the company’s suite of biological drugs. Ensure continuous
adherence with the varying and complex regulations for sampling and inspection methodologies / techniques for
products shipped to 72 countries worldwide. Serve as a core member of the company’s senior-level Quality
Control strategic leadership team.
Achieved $1.5M in annual savings and reduced turnaround time for inspections by more than 23 days as
lead over a site-wide project to identify, streamline, and institutionalize best practices for the incoming
Paved the way for a 17% headcount reduction and received 1st place at the Bayer Operational Excellence
Fair with the project’s dramatic improvements to efficiency and automation.
Enhanced management’s view, tracking, and measurement of quality control’s operational performance,
enabling improved opportunity identification and decision making by launching a comprehensive analysis and
benchmarking effort for the various QC tasks.
Recognized for outstanding performance and improvements to service delivery with 2 separate Special
Manager for Quality Control Document Management (2008-2009)
Selected to build this specialized group from the ground up as a key component of a Quality Control
organizational restructure. Recruited, trained, and managed a 7-member team with full accountability for a $1M
budget in the streamlined provision of centralized documentation services for the 200-employee QC division.
Established and oversaw an internal control and documentation auditing system to ensure continuous
compliance with such regulations as Sarbanes-Oxley.
Directed the successful integration of the next-generation Xerox DocuShare digitizing system, transforming
the formerly manual document-retrieval process into a real-time, high-accessibility, Web-based system.
Built this new team into a recognized center of excellence for service, support, and responsiveness,
effectively defining the team’s strategic direction and operational plan to optimize its contribution to the
TOM NORTON Page 2 email@example.com
BAYER HEALTHCARE (continued)
Senior Supervisor for Quality Control, Incoming Materials Inspection (2007-2008)
Stepped in to turn around an under-performing operation, leading and coaching a 12-member team to drive a
fresh effort to achieve full compliance with global regulatory guidelines while providing an efficient system for
evaluating incoming materials.
Increased the team’s achievement rate for meeting materials release deadlines to 99% from a low of 55%
with such operational overhauls as a new Excel metrics spreadsheet to track the end-to-end materials
Significantly lowered the number of customer complaints and revitalized the team into a high-morale group
recognized organization-wide for superior performance.
Acknowledged for going above-and-beyond in driving the local facility’s contribution to key global projects
with 2 separate “STAR” awards presented by Bayer AG in Germany.
Senior Quality Control Supervisor,
Potency Laboratory (2005-2007) & ELISA (Enzyme-Linked Immunosorbent Assay) Laboratory (2002-2005)
Directed all quality control efforts within these 2 labs, managing teams of between 8 and 12 analysts to ensure
efficient delivery of critical QC services.
Tapped to transition to the site’s most mission-critical lab, the rFVIII Potency Laboratory, successfully
delivering on a charge to improve analyst performance while collaborating with a variety of cross-functional
teams to ensure the adherence to strict potency specifications throughout the manufacturing process.
Chosen as the sole QC representative to a confidential strategic research team investigating the feasibility of
a potential product purchase from a competitor.
Drove such performance improvements within the ELISA lab as a more than 50% reduction in sample
turnaround time by implementing the lab’s first-ever system for measuring and tracking productivity and
Rebuilt a formerly strained relationship between the ELISA lab and the rest of the site by strategically
communicating these outstanding performance improvements.
Recognized for superior dedication and leadership with 2 separate Special Recognition Awards and the elite
Premier Circle Award given to less than 5% of employees.
OKLAHOMA MEDICAL RESEARCH FOUNDATION, Oklahoma City, Oklahoma
(Formerly part of the SAMUEL ROBERTS NOBLE FOUNDATION; transferred through the biomedical division)
One of the nation’s oldest and most renowned non-profit biomedical research institutes.
Senior Research Associate / IT Specialist
Conducted wide-ranging biomedical research projects, supervising post-doctoral fellows and summer interns as
a senior manager over the various research labs. Additionally developed, implemented, and maintained the
department’s IT plan and infrastructure.
Co-authored 10 papers published in peer-reviewed journals along with 17 papers presented at national and
international conferences. (Complete listing of publications available upon request.)
Master of Science in Computer Information Systems University of Phoenix, Oklahoma City, Oklahoma
Bachelor of Science in Chemistry Oklahoma State University, Stillwater, Oklahoma
Microsoft Certified Systems Engineer (MCSE)
PROFESSIONAL AFFILIATIONS: Parenteral Drug Association; Director of the Executive Board & Senior
Member, American Society for Quality.