Elizabeth B. Stutts
Sanford,NC
Summary
Accomplished at Pfizer, Inc., I spearheaded quality and compliance initiatives, optimizing processes and fostering collaborative partnerships. My strategic planning and interdepartmental leadership skills achieved significant enhancements in GMP alignment and regulatory compliance, demonstrating a commitment to excellence and continuous improvement in the pharmaceutical industry.
Overview
19
19
years of professional experience
Work History
Sr. Manager, Health Authority Reporting/APRRs
Pfizer, Inc.
09.2021 - Current
- Lead the quality Annual Product Review process as the Global Process Owner.
- Lead the cross-functional APR optimization project under the PGS Revolution program to standardize the APR process via global documents, with internal sites and functions.
- Raise quality issues in a timely manner through effective communication with the correct management levels.
- Maintained compliance by filing all FAR and BPDR Board of Health reports accurately.
- Organize AQRT sessions involving cross-site collaboration with senior leadership.
- Review, author, and provide approval for relevant global policies.
- Deliver comprehensive training on GMP and Quality Systems.
- Partner with internal stakeholders including sites and markets.
- Monitor ongoing changes in regulations and market trends.
- Evaluate processes to ensure alignment with GMP expectations.
Manager, Compliance-Global Quality Organization
Pfizer, Inc.
09.2014 - 09.2021
- Managed end-to-end process for corporate documentation.
- Reviewed, authored, and provided approval for relevant global policies.
- Streamlined interdepartmental communication to ensure timely project milestones.
- Executed strategies for incorporation of quality documentation during site acquisitions.
- Raised quality issues in a timely manner through effective communication with the correct management levels.
Senior Quality Specialist II
Pfizer, Inc.
Sanford, USA
10.2010 - 09.2014
- Functioned as site quality training lead.
- Conducted quality assurance evaluations for site investigations.
- Performed site self-inspections, adhering to health board regulations.
- Created and disseminated audit reports for site self-inspections.
- Conducted BOH site inspections.
- Evaluated supplier performance through audits.
- Managed suppliers, supplier qualification, and material qualification.
- Reviewed and approved Quality Agreements.
- Led Site Inspection Readiness Team.
- Designed and implemented effective training programs for site readiness inspections.
- Engaged in managing commitments.
- Engaged in Site Quality Review Team meetings to address quality issues with management.
- Coordinated adherence to corporate quality standards through active communication between the site and Corporate Compliance Operations.
- Authored, reviewed, and approved site SOPs.
- Performed various lab activities, such as sample management, QC lab data authorization, authoring/reviewing lab investigations, authoring/reviewing change controls, and ensuring schedule adherence with laboratory testing.
- Ensured data integrity for laboratory and quality systems.
QA Manager
Pfizer, Inc.
Sanford, USA
12.2005 - 10.2010
- Supervised a team of 10 colleagues and contractors to ensure compliance of equipment, facilities, laboratory instruments, and test methods.
- Oversaw stability program for the site.
- Facilitated cross-departmental communication for the QA team at multiple levels.
- Conducted compliance reviews of calibration and preventative maintenance records for new and existing equipment.
- Facilitated approval of new test method technology transfers.
- Supervised processes for quality assurance investigations.
- Oversaw BOH inspections, ensuring inspectors were escorted and reports were accurate.
- Conducted comprehensive internal audits.
- Guided development of team members.
- Spearheaded department budget creation, maintaining adherence to cost-effective strategies.
Education
Bachelor of Applied Science -
Campbell University
01.2000
Associate of Applied Science -
CCCC
01.1987
Skills
- Collaborative Partnership Building
- Strategic planning
- Talent development
- Financial Planning Oversight
- Interdepartmental Leadership Skills
- Effective Team Communication
- Multidisciplinary Collaboration
Timeline
Sr. Manager, Health Authority Reporting/APRRs
Pfizer, Inc.
09.2021 - Current
Manager, Compliance-Global Quality Organization
Pfizer, Inc.
09.2014 - 09.2021
Senior Quality Specialist II
Pfizer, Inc.
10.2010 - 09.2014
QA Manager
Pfizer, Inc.
12.2005 - 10.2010
Bachelor of Applied Science -
Campbell University
Associate of Applied Science -
CCCC
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