Jennifer Hunter
Senior Program Leader | $100M+ Capital Projects | Enterprise SaaS Implementations | GxP/GMP | CSV, QMS & Digital Transformation Expert
- Role
- Director, Quality & Compliance at Strategic Maintenance Solutions, Inc
- Location
- Harrisburg, PA, US
- LinkedIn followers
- 500 followers
About Jennifer Hunter
I am a Senior Program & Implementation Leader with 20+ years of experience delivering…
Experience
Director, Quality & Compliance
Strategic Maintenance Solutions, Inc
Jul 2005 — Present · Gorham, ME, US
Lead global quality, compliance, and capital readiness strategies for life sciences and pharmaceutical clients, ensuring alignment with GxP, FDA, EMEA, and GMP regulations.Designed and maintain an enterprise-level Quality Management System (QMS), enabling standardization across SaaS deployments and regulated facility readiness projects.Partner with executive stakeholders on multi-million-dollar implementation strategies, integrating physical infrastructure and validated IT systems into unified enterprise platforms.
Education
The Johns Hopkins University
Masters in Science
1998 — 2002
Lebanon Valley College
BS
1993 — 1997
Skills
- Change Control
- Gxp
- Quality Auditing
- Aseptic Processing
- Glp
- Gmp
- Project Management
- Gamp
- Software Project Management
- Regulatory Requirements
- Pharmaceutical Industry
- Sop
- Maintenance Management
- Fda
- Iso 13485
- Quality System
- V&V
- Document Management
- Cleaning Validation
- Auditing
- Quality Management
- 21 Cfr Part 11
- Validation
- Manufacturing
- Project Planning
- Biotechnology
- Regulatory Affairs
- Lims
- Maximo
- Capa
- Computer System Validation
- Quality Assurance
- Corrective and Preventive Action (Capa)
- Data Quality
- Technology Transfer
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