NORMAN MOFFETT
Glen Gardner
Summary
Experienced leader with 28 years in GMP and GLP, including 14 years in supervisory roles. Resolves complex issues and drives team performance through strategic planning focused on quality, safety, and continuous improvement. Participated in 17 regulatory and customer inspections with minimal observations, fostering effective interdepartmental communication.
Overview
28
28
years of professional experience
Work History
QA Manager
Gilead Sciences
10.2020 - Current
- Quality Operation Lead (OL) for the CMC technology transfer, validation and commercialization of immunotherapy manufacturing processes. As the OL, provided quality guidance and made management decisions to maintain commercial timelines.
- Independently owned quality processes end-to-end to ensure full compliance with company, regulatory, and global quality standards.
- Established quality oversight of contract manufacturer organizations (CMO) to ensure compliance with regulatory and company standards.
- Performed pre-audit walkthroughs and routine internal audits to ensure target areas are always inspection ready.
- Project lead for quality-based decision tree implementation, inspection storyboard, and particulate library implementation.
- Skilled in conducting interviews, on-boarding, training, and managing new hires and contractors. Trained quality personnel on deviation investigation, CAPA, and extension request management.
- Authored, reviewed and approved GxP documents, including MBRs, deviation investigations, change controls, impact assessments, complaints, validation protocols, and risk assessments.
Principal Specialist
Immunomedics
04.2020 - 10.2020
- Purchased by Gilead Sciences in October 2020
- Performed deviation investigations in multiple departments, including Facilities, Metrology, Manufacturing, Validation, Shipping, Security, and IT.
- Wrote the associated deviation reports.
- Initiated CAPAs and Effectiveness Checks, as required.
- Typically had 10 to 12 deviations in my queue for investigation.
- Helped bring the deviation workload down from 450+ overdue to 25 open investigations as a baseline.
Supervisor
Eli Lilly and Company
04.2014 - 04.2020
- Supervisor for technical services, including contractor management, Facilities management, Office Services, and Security.
- Supervised twelve direct reports and managed their daily tasks.
- Coordinated projects and supervised fit-and-finish activities across a biopharmaceutical manufacturing campus of five buildings.
- Supervised the purchasing, inventory, and distribution of the spare parts program.
Senior Specialist
Eli Lilly and Company
01.2006 - 04.2014
- Performed deviation investigations in multiple departments, including Facilities, Metrology, Manufacturing, and Validation.
- Wrote the associated deviation reports.
- Initiated CAPAs and Effectiveness Checks, as required.
- Performed audits of production, utilities, and maintenance programs to ensure inspection readiness at all times.
- Performed scribe activities for multiple inspections, including FDA, EMA, PDMA, TGA, Health Canada, and COFEPRIS.
- My personal scribe template became the standard template for my site.
Supervisor, Buffer Preparation
ImClone Systems
03.2004 - 01.2006
- Supervisor for a commercial manufacturing Buffer Preparation suite.
- Managed 8-10 direct reports across two shifts.
- Responsible for the weekly scheduling of the preparation of 10 to 12 buffers used in Downstream operations.
- Reviewed buffer batch records, revised procedures, coordinated maintenance of equipment, wrote deviations, and implemented CAPAs.
- Performed interviews of new employees and onboarding activities.
- Provided training to new employees.
Operator
North American Vaccine
08.1998 - 01.2001
- Executed manufacturing operations for buffer preparation, media preparation, fermentation, purification, and bulk fill for clinical manufacturing campaigns, ensuring adherence to quality standards and timelines.
Education
B.S - Molecular Biology
Mary Washington College
Fredericksburg, Virginia01-1998
Skills
- CGMP Regulatory Requirements
- CGMP compliance
- Quality Assurance Guidance
- Compliance Auditing
- CAPA Management
- Deviation Investigation
- Process Validation
- Leadership Development
- Quality Assurance Guidance
- Risk Assessment
- Program Implementation
- Project Coordination
- Leadership
- Team Leadership
- Extensive Management Training
- Communication
- Conflict Resolution
- Quality assurance
- Kepner-Tregoe PSDM
Personal Information
Title: SENIOR QUALITY SPECIALIST
Notable Accomplishments
- Performed several gap analysis on CMO documents, including deviations reports, master batch records (MBRs), change controls, and validation protocols to ensure cGMP compliance.
- Independently created CAPA plans to address gap assessments, resulting in CMO being more inspection ready.
- Reduced CMO deviation report review/approval time to meet quality agreement timelines.
- Lead investigator of a biofilm investigation that saved an estimated $100 million dollars in product.
- Implemented a business continuity plan that resulted in no loss of service for work order execution.
- Wrote complaint pilot study protocol to reduce approval times on CMO complaint investigations. Independently researched appropriate quantitative and qualitative (efficiency improvement) acceptance criteria.
Timeline
QA Manager
Gilead Sciences
10.2020 - Current
Principal Specialist
Immunomedics
04.2020 - 10.2020
Supervisor
Eli Lilly and Company
04.2014 - 04.2020
Senior Specialist
Eli Lilly and Company
01.2006 - 04.2014
Supervisor, Buffer Preparation
ImClone Systems
03.2004 - 01.2006
Operator
North American Vaccine
08.1998 - 01.2001
B.S - Molecular Biology
Mary Washington College