JESSICA GUTSHALL
Cary
Summary
Senior Manager with proven expertise in regulatory compliance and quality processes. Skilled in leading teams to improve operational efficiency through strategic initiatives. Strong background in quality and collaboration to ensure project success and adherence to industry standards.
Overview
12
12
years of professional experience
Work History
Manager, Quality Control Data Review
FujiFilm Diosynth Biotechnology USA Inc
Morrisville
01.2022 - 06.2022
- Manage the QC data review Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
- Coordinate and oversee technical and compliance review of QC analytical testing for GMP batch release and stability testing.
- Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
- Assist in developing and managing QC budget.
- Review and approve data and reports for release and stability testing, as required.
- Ensures laboratory compliance to established specifications and procedures.
- Report excursions/out of specifications results and conduct investigations as needed.
- Assure the implementation of appropriate and timely corrective actions.
- Work closely with Quality Control and Quality Assurance and other departments to continuously improve the effectiveness of the data review team.
- Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
- Interface with current and potential clients as well as interface with regulatory investigators during internal and external inspections.
- Follow all established laboratory, regulatory, safety, and environmental procedures.
- Identify deviations and report possible preventive and corrective actions using TrackWise and other electronic systems as needed.
Senior Manager Analytical/Formulation Sciences
KBI
Durham
06.2022 - 09.2025
- Executed strategic initiatives aligning departmental goals with organizational objectives.
- Managed a team of 20+ employees by providing guidance, setting goals and objectives, delegating tasks, and monitoring performance.
- Conducted risk assessments to identify compliance issues and implemented corrective actions.
- Monitored adherence to regulatory standards and internal policies across operational processes.
- Analyzed workflow processes to identify bottlenecks and recommended solutions for improvement.
- Assured timely communication of project updates to stakeholders, fostering transparency and collaboration across teams.
- Established relationships with stakeholders to support project objectives and engagement.
- Reviewed and approved Standard Operating Procedures to ensure Good Manufacturing Practices compliance.
- Coordinated regular training sessions for staff to enhance technical skills and ensure compliance with industry best practices.
- Developed and delivered GMP training for incoming scientists, enhancing compliance knowledge.
- Led weekly compliance hour meetings for Analytical and Formulation staff to address inquiries.
- Ensured compliance with applicable laws, regulations, policies, and procedures across all business units.
Supervisor, Quality Control-Commercial
FujiFilm Diosynth Biotechnology USA Inc
Morrisville
12.2020 - 01.2022
- Supervises, coordinates, and assures review and final release of data in support of stability testing.
- Reviews and approves data.
- Performs historical data review and reconciliation.
- Provides day to day tactical and logistical support for achieving department objectives.
- Anticipates and proactively manages potential problems that affect compliance.
- Anticipates and reacts to technical problems, coordinates investigations, and develops appropriate solutions; assuring that timelines and milestones are met.
- Evaluates and approves deviations / investigation reports / change management requests.
- Evaluates and approve protocols.
- Assures staff is fully trained and immediately corrects gaps or deficiencies.
- Oversees, coordinates, and ensures execution of activities and/or projects according to timelines.
- Identifies and implements processes for improving time / cost efficiency for allocation of resources.
- Conducts performance evaluations and provides constructive feedback to direct reports on an ongoing basis.
- Facilitates development opportunities to direct staff.
Manager, Quality Control
Recipharm
Morrisville
04.2018 - 12.2020
- Technical and Managerial head of Quality Control Team.
- Schedule GMP and GLP data review and report submission.
- Author or Approver of Out of Range Reports, Deviation, and Change Controls.
- Performs root cause analysis for deviations and investigations.
- Author of Standard Operating Procedures.
- GMP/GLP data and EMPOWER review for inhalation, OSD, and transdermal products.
- Approve GMP/ GLP Certificate of Analysis for both release, stability, and IVBE.
- Manage GMP/GLP stability data trending and statistics.
- Oversee shipping, receiving, and storage of materials while maintaining GMP/GLP chain of custody.
- Head of sample management including GMP/GLP warehouse and temperature-controlled storage units.
- Author or Approve stability chamber mapping protocols.
- Responsible for GMP/GLP Stability Program.
- Maintain IVBE program; storage, data blinding/unblinding, review, and reporting.
- Site Controlled Substance Custodian.
- Member of site training committee and GDP SME.
Associate Manager, Quality Control
Tergus Pharma, LLC.
Durham
02.2017 - 04.2018
- Lead Quality Control team.
- Schedule GMP release and GMP stability testing.
- Communicate with clients regarding GMP testing, GMP storage of samples, deviations, and Laboratory Investigation reports (LIR).
- Perform LIR, Deviation, and Change Control Approval including root cause analysis.
- Author Stability Protocols.
- GMP data and EMPOWER review.
- Approve GMP Certificate of Analysis.
- Perform QC raw material release.
- Author stability chamber mapping protocols.
- Perform QC approval of in-process and finished good specifications.
- Coordinate equipment calibration and service.
- Perform equipment calibration verification and sign-off.
- Standard Operating Procedure (SOP) author.
- Change Control, Deviation, LIR author.
- Cleaning Verification data review and approval.
- Coordinate data review/ release with Quality Assurance.
Senior Stability Specialist
Mylan Pharmaceuticals Inc.
Morgantown
09.2013 - 01.2017
- Facilitate annual stability set down process of Mylan manufactured and/or packaged products through monitoring our SAP Stability Table Transaction program, manual tagging, or SAP queries.
- Perform quality assessment on incoming stability samples and current stability studies to determine if samples remained in stability program or deemed for pharmaceutical destruction.
- Maintain Microsoft Excel documents used in tracking Annual Retention Sample Review.
- Coordinate and evaluate all documentation required for induction of a representative sample for a production batch into the stability program.
- Manage and investigate stability studies to ensure compliance with cGMP and current filing regulations.
- Perform regulatory task records for stability necessary for regulatory agency submission.
- Perform investigation, quality impact assessments and CAPAs on any deviation from Standard Operating Procedure in TrackWise.
- SAP Subject Matter Expert and liaison for Stability.
- Standard Operating Procedure (SOP) Author and Subject Matter Expert (SME).
- Change Control author and coordinator.
- Liaison for requisition of product from Distribution Center for Stability Program.
- Provide customer service to Quality Control Laboratory, Research and Development Laboratory, and Quality Technical Services.
- Serve as team lead for the Quality Assurance Stability Operations team.
- Direct operations team in daily activities and ensuring a quality mindset in decision making.
- Provide guidance in daily tasks to bargaining unit union employees.
Education
Masters of Science - Chemistry
West Virginia University
Morgantown, WV12.2025
Bachelor of Science - Chemistry
West Virginia University
Morgantown, WV01.2005
Skills
- Microsoft Office Suite
- Laboratory information management systems
- TrackWise and Sparta
- SAP applications
- Documentum compliance management
- High-performance liquid chromatography
- Ultra-performance liquid chromatography
- Ultraviolet detection
- Photodiode array detection
- Electrochemical detection
- Refractive index detection
- Fluorescence spectroscopy
- Mass spectrometry techniques
- Gas chromatography-mass spectrometry
- Inductively coupled plasma analysis
- Infrared spectroscopy
- Capillary electrophoresis
- Nuclear magnetic resonance spectroscopy
- Quality control processes
- Standard operating procedures development
- Regulatory compliance expertise
- Team leadership skills
- Data analysis techniques
- Problem-solving strategies
- Statistical analysis methods
- Technical documentation expertise
Affiliations
- Member of Gamma Beta Phi Honor Society
- Member of American Chemical Society
- Coach/Mentor for Girls On The Run
Timeline
Senior Manager Analytical/Formulation Sciences
KBI
06.2022 - 09.2025
Manager, Quality Control Data Review
FujiFilm Diosynth Biotechnology USA Inc
01.2022 - 06.2022
Supervisor, Quality Control-Commercial
FujiFilm Diosynth Biotechnology USA Inc
12.2020 - 01.2022
Manager, Quality Control
Recipharm
04.2018 - 12.2020
Associate Manager, Quality Control
Tergus Pharma, LLC.
02.2017 - 04.2018
Senior Stability Specialist
Mylan Pharmaceuticals Inc.
09.2013 - 01.2017
Masters of Science - Chemistry
West Virginia University
Bachelor of Science - Chemistry
West Virginia University