Whitney Sandberg
Partner @ ELIQUENT Life Sciences
- Role
- Partner at ELIQUENT Life Sciences
- Location
- Longmont, CO, US
- LinkedIn followers
- 500 followers
About Whitney Sandberg
Experienced professional with proven abilities to lead significant, complex organizational transformational efforts driving compliance enhancement, cost reduction, and integration across diverse organizations. Extensive expertise in quality operations, compliance enhancement/remediation, and supply chain integration in pharmaceutical, medical device, and biopharmaceutical operations. Previously served on the site leadership teams of large, complex manufacturing operations leading Quality teams through significant compliance enhancement and operational transformation activities. Direct experience in solid dosage, liquid, cream, aseptic, and nuclear medicine pharmaceutical/biopharmaceutical products and a broad range of medical device products. A passion for individual and team development through coaching, mentoring, delegation, and day-to-day collaboration. A proven and respected leader with success in bringing stability and operational improvement to diverse organizations. Significant experience with international manufacturing organizations.
Experience
Partner
Jan 2025 — Present · Boulder, CO, US
Providing strategic guidance and support to biotech and cell & gene therapy companies in areas including the following:Developing quality and compliance strategiesImplementing and enhancing quality systemsAssisting clients in developing and communicating compliance plans (responses) to regulatory authoritiesProviding inspection readiness including audits Coaching and mentoring staff in key quality and compliance areas
Education
Southern Illinois University, Carbondale
Bachelor of Science (BS), Chemistry
Skills
- Gmp
- Quality System
- V&V
- U.s. Food and Drug Administration (Fda)
- Regulatory Affairs
- Glp
- Cleaning Validation
- Computer System Validation
- Pharmaceutical Industry
- Sop
- Fda
- Biotechnology
- Lims
- Gxp
- Aseptic Processing
- Change Control
- Capa
- Supplier Quality
- Validation
- 21 Cfr Part 11
- Biopharmaceuticals
- Contract Manufacturing
- Corrective and Preventive Action (Capa)
- Quality Assurance
- Technology Transfer
- Standard Operating Procedure (Sop)
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