Amanda Berkhammer
Head, Site Quality
- Role
- Quality Director at MilliporeSigma
- Location
- Rockville, MD, US
- LinkedIn followers
- 500 followers
About Amanda Berkhammer
Quality Director with 20+ years of progressive experience in quality management, regulatory compliance, and process improvement within a cGMP-regulated contract testing organization. Proven leader in directing large, high-performing teams and managing domestic and international regulatory inspections, consistently achieving successful outcomes. Recognized for driving organizational transformation, implementing global quality systems, and championing initiatives that enhance customer satisfaction, employee engagement, and operational excellence.
Experience
Quality Director
Nov 2015 — Present · Rockville, MD, US
This role has full site quality accountability for Rockville, MD contract testing facility, which also serves as an active member of the Site Leadership Team. Direct a team of up to 90+ Quality professionals, including both first- and second-line managers, with focus on developing people and high-performing teams.Key accomplishments include:(1) Led twelve inspections by domestic and global health authorities (FDA, MHRA, AIFA, HPRA, FIMEA, TGA, AGES), consistently achieving successful outcomes including multiple inspections with zero 483 or major/critical deficiencies (2) Developed and executed quality and regulatory readiness strategies for a newly constructed sq ft Rockville facility (2024/5) and oversaw QMS implementation at the new Singapore testing site (2019)(3) Acted as a change leader for global compliance and operational improvement initiatives, driving harmonization and best practices across the organization
Education
The Johns Hopkins University
M.S., Biotechnology
2005
University of Pittsburgh
B.S., Biology
2001
Skills
- Lims
- Gxp
- Capa
- Biotechnology
- 21 Cfr Part 11
- Quality Assurance
- Quality Control
- Gmp
- Compliance
- Biopharmaceuticals
- Pharmaceutical Industry
- Sop
- Fda
- Cleaning Validation
- Lifesciences
- Validation
- Quality System
- V&V
- Software Documentation
- Computer System Validation
- Glp
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