Mike Pierce
Associate Director, Quality Programs
- Role
- Associate Director Quality Programs at Pfizer
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Mike Pierce
Pharmaceutical/biotech professional specializing commercializing new drug products and the validation of the related facilities and processes. Extensive experience in engineering, validation and quality assurance with a passion for quality systems and program management. A proven track record of building efficient and effective processes and procedures that assure quality and regularity compliance.Specialties: Validation Maintenance, Change Control, Process Monitoring, Project Management, Equipment Qualification, Cleaning Validation, Computer Validation, Sterilization, Sanitization, Process Validation, Quality Management Systems, Quality by Design, LEAN, Operational Excellence
Experience
Associate Director Quality Programs
Dec 2023 — Present · Seattle, WA, US
Education
Vanguard University of Southern California
Bachelors, Biology, Chemistry, Music
1993 — 1997
Skills
- Computer System Validation
- Calibration
- Hplc
- Quality by Design
- Quality System
- Quality Systems
- V&V
- Process Simulation
- Aseptic Technique
- Glp
- Operational Excellence
- Project Management
- Regulatory Requirements
- Quality Assurance
- Cleaning Validation
- Process Validation
- Testing
- Fda Gmp
- Lims
- Pharmaceutical Industry
- Sop
- Fda
- Software Documentation
- Cell Culture
- Quality Control
- Gmp
- Validation
- Chromatography
- 21 Cfr Part 11
- Technology Transfer
- Pharmaceutics
- Fermentation
- Biotechnology
- Gxp
- Equipment Qualification
- Quality Auditing
- Aseptic Processing
- Change Control
- Trackwise
- Biopharmaceuticals
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