Chris Golden

About Chris Golden

Results-oriented Professional with expertise in Project and Quality Management. Knowledge of FDA Quality System Regulations (QSR), ISO Regulations, GMP, GLP, and GDP. Track record of a self-starter, constantly looking to identify and implement cost reductions and product and process improvements. Skilled in managing product performance investigations. Well-developed communication and problem-solving skills with the ability to resolve difficult situations. Critical thinker with innovative mindset who can apply acquired knowledge to improve operation efficiency, deliver process improvements, and drive business objectives.Specialties: Cost reduction • Innovation • Development • Compliance • Process improvement • Leadership • Continuous Improvement • Customer Satisfaction • Nonconformances • Validations • Technical Expertise • Quality Audits • Analytical Problem Solving • Design Control • FDA • GMP/GLP/GDP • ISO 13485 • ISO 9001 • IPEC • Process Evaluation • CAPA • Change Control • SAP • Complaint Investigations • Deviations

Experience

1. Sr Director, Site Quality Head Lonza Bioscience

   Lonza

   Aug 2022 — Present · Walkersville, MD, US

   Provides high-level leadership and oversight for all Quality Assurance and Quality Control operations at the Lonza Walkersville facility. Responsible for ensuring that all products meet or exceed regulatory requirements, customer expectations, and internal quality standards.

Education

• University of Illinois Springfield

  ACS certified B.S., Chemistry

  1992 — 1994

Skills

• U.s. Food and Drug Administration (Fda)
• Uv/Vis
• Testing
• Gas Chromatography
• Project Management
• Capa
• Corrective and Preventive Action (Capa)
• Cleaning Validation
• Gxp
• Quality Auditing
• Chemistry
• 21 Cfr Part 11
• Operational Excellence
• Iso
• Quality Management
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Calibration
• Change Control
• Analytical Chemistry
• Quality System
• V&V
• Hplc
• Quality Assurance
• Quality Control
• Gmp