OVERVIEW
FOCUS AREAS
Almost 30 years experience in quality in the pharmaceutical/biotech industry.
Quality Enhancement Plans
Quality Strategy as an Enabling Business Driver
Cultural Transformation
As Partner of ELIQUENT Life Sciences, Whitney works with clients globally to remediate quality and compliance challenges with a focus on biologics and cell and gene therpay modalities. She leverages her deep industry experience to work with clients to develop strategic Quality Enhancement Plans that balance a pragmatic approach with a compliant solution that meet or exceed the clients expectations.
In my role as SVP and GM, I led an organization through the ramp-up of a 20K mammalian stainless steel operation at AGC Biologics in Boulder, Colorado including the culture transformation of a site working through start-up, and facility and staff integration. I Implemented a high performing leadership team and hired key staff leaders resulting in improved facility reliability and increased employee engagement.
In addition, I oversaw the build-out and start-up of a dedicated cell and gene therapy facility in Longmont, Colorado.
I achieved successful operations in two facilities, showcasing my strong leadership and project management skills.
I also hosted multiple client visits and received positive feedback on staff knowledge and engagement.
In my role as Sr. Director Quality at Thermo Fisher Scientific, I led a global team overseeing Quality for the biologics business unit which included single use mammalian, and cell therapy operations. I successfully hosted regulatory inspections from major agencies including FDA, PMDA, Health Canada, and MFDS resulting in product approvals across global markets.
I also implemented phase appropriate quality into the quality system in order to assist with speed to clinic delivery for early phase products.
In my roles as Sr. Director (integration), I was responsible for all post-acquisition integration activities for Quality and Operations including: assimilation of supply chain activities, quality/compliance remediation, organizational optimization, and systems. In addition, my group worked across functional and corporate lines to maximize operational effectiveness, while optimizing value capture. A key component of this function was developing, nurturing, and growing relationships (beginning during due diligence) that enhanced collaboration and teamwork. My team standardized many of these functional activities through the development of a detailed integration playbook, checklists, processes, and procedures.
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EDUCATION:
Bachelor of Science, Southern Illinois University
CERTIFICATIONS:
Certified Quality Auditor (CQA), American Society for Quality (ASQ)
Certified Quality Engineer (CQE), ASQASSOCIATIONS:
PDA Missouri Valley, Chapter Board Member, 2018-2021
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- AGC Biologics- SVP and General Manager, 3 years
- ThermoFisher Scientific- Sr. Director Quality Biologics Business Unit, 4 years
- Mallinckrodt Pharmaceuticals- Sr. Director Operations Integration, 2 year
- Mallinckrodt Pharmaceuticals- Site Head of Quality (Nuclear Medicine, API) 3 years
- Covidien- Sr. Manager Quality Improvement, 2 years
Quality Management System, Building High Performing Teams, Root Cause Analysis, Investigation Management, Data Analytics, Quality Culture, CAPA, Coaching and Mentoring
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