Jennifer Bakula
Senior Director, Quality and Compliance
- Role
- Senior Director Quality and Compliance at Eli Lilly and Company
- Location
- Kenosha, WI, US
- LinkedIn followers
- 500 followers
About Jennifer Bakula
Results-oriented quality assurance professional offering more than 20 years’ experience leading compliance initiatives within large, international pharmaceutical and biotechnology firms. Accomplished leader known for technical guidance and managerial acumen, providing insight and clarity into complex domestic and international compliance regulations. Highly skilled in defining best practices and standard operations procedures as well as building and delivering multifaceted audit and inspection training programs. Equipped with strong scientific background and skill to quickly identify and correct procedural inefficiencies. Exhibits exceptional communication and analytical abilities. Areas of expertise:Quality Control & Assurance • Compliance • System- & Process-based AuditsRegulatory Filings • Inspection Preparation, Management, & Response • International ExpansionChange Management • Special Projects • Team Motivation • Training & Development • Quality System Remediation•Investigations•CAPA
Experience
Senior Director Quality and Compliance
Nov 2024 — Present · Pleasant Prairie, WI, US
Education
Winona State University
Bachelor of Science, Cell and Molecular
1992 — 1996
Winona State University
Bachelors Degree Obtained a Bachelor of Science, Biology; Cell and Molecular Option; Molecular Biology, Microbiology
1992 — 1996
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Technology Transfer
- High-Performance Liquid Chromatography (Hplc)
- Quality Control
- Gmp
- U.s. Food and Drug Administration (Fda)
- 21 Cfr Part 11
- Capa
- Lims
- Standard Operating Procedure (Sop)
- Quality System
- V&V
- Biopharmaceuticals
- Gxp
- Quality Auditing
- Aseptic Processing
- Verification and Validation (V&V)
- Software Documentation
- Glp
- Corrective and Preventive Action (Capa)
- Validation
- U.s. Title 21 Cfr Part 11 Regulation
- Cleaning Validation
- Gamp
- Biotechnology
- Purification
- Change Control
- Good Laboratory Practice (Glp)
- Laboratory Information Management System (Lims)
- Quality Assurance
- Hplc
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