Heather Dudek
Quality - Compliance
Barto,PA
Work Preference
Summary
Accomplished Quality Systems and Compliance leader with 24 years of experience in pharmaceutical and medical device industries. Expertise in managing global Quality Management Systems, regulatory readiness, and audit programs to enhance quality governance. Skilled in developing scalable quality processes, overseeing TrackWise platforms, and collaborating with senior leadership to strengthen compliance and drive continuous improvement.
Overview
24
24
years of professional experience
Work History
Senior Quality Technical Consultant, Global Quality & Compliance
Baxter Healthcare
Round Lake
02.2016 - Current
- Lead enterprise governance for Baxter’s global internal audit and external inspection quality systems, ensuring alignment with regulatory expectations and organizational standards.
- Serve as Business Process Owner for TrackWise audit and inspection workflows, overseeing system validation, implementation, optimization, and lifecycle management.
- Direct global regulatory inspection readiness and act as primary liaison with health authorities, supporting successful inspections and outcomes.
- Develop and maintain corporate procedures, governance frameworks, and training programs to standardize and strengthen enterprise audit processes.
- Deliver executive-level quality metrics, insights, and trend analyses to senior leadership, informing strategic decision-making and management reviews.
- Drive continuous improvement initiatives, including the design and implementation of the Global Observation Certification process to enhance compliance and consistency.
- Support acquisitions and divestitures by leading quality due diligence, integration planning, and separation activities to ensure regulatory compliance and business continuity.
- Coach and mentor global quality professionals while fostering cross-functional collaboration to elevate organizational capability and performance.
Quality Associate III – Global Quality & Compliance
Baxter Healthcare
09.2009 - 02.2016
- Global process owner for External Inspection Management and Enforcement Letter tracking.
- SME for TrackWise External Inspection workflows and enhancements.
- Produced executive dashboards and quality metrics for Board and Management Reviews.
- Analyzed global inspection trends and supported CAPA, regulatory submissions and risk management.
- Represented Baxter in external conferences and mentored junior staff.
Senior Technologist – Global R&D
Baxter Healthcare
Round Lake
06.2007 - 09.2009
- Developed and authored technically rigorous batch records, protocols, and supporting documentation in compliance with GMP standards.
- Executed feasibility and formulation development studies to support Scientific Affairs projects and product innovation initiatives.
- Designed and managed short-term stability studies for finished products, ensuring accurate data collection and regulatory compliance.
- Performed analytical testing for in-process and final product nanosuspensions, supporting product quality and release readiness.
- Authored, revised, and implemented departmental SOPs to align with evolving corporate policies and regulatory requirements.
- Collaborated closely with Study Directors to enable successful technology transfer from R&D to pilot plant operations, ensuring scalability and process consistency
- Mentored junior technologists in troubleshooting and problem resolution.
- Collaborated with cross-functional teams to enhance product development processes.
Senior Technologist – Injectable Formulation Technology
Baxter Healthcare
Round Lake
04.2002 - 06.2007
- Authored and executed technically rigorous validation protocols and reports to support compliant manufacturing operations.
- Led documentation and execution of process, system, and equipment validation activities within the IFT Pilot Plant, ensuring strict adherence to cGMP, environmental, health, and safety requirements.
- Developed, revised, and implemented departmental SOPs to maintain alignment with evolving corporate policies and regulatory standards.
- Supported aseptic Phase I clinical manufacturing within isolator technology, contributing to batch and system release, client interactions, batch record review, and nonconformance investigations.
- Coordinated and delivered training programs for manufacturing and quality personnel to ensure compliance and operational readiness.
- Participated in internal and corporate audits, supporting inspection readiness and continuous improvement initiatives.
- Coordinated daily manufacturing activities and provided informal leadership and supervision to production personnel.
- Contributed to the successful technology transfer of the NanoEdge platform, including support for the construction and startup of a new cGMP facility in Halle, Germany.
Education
Bachelor of Science - Biology
Elmhurst College
Elmurst, IL06-2001
Skills
- GMP quality assurance
- FDA inspection readiness
- CAPA management
- Audit management / optimization
- Global quality systems leadership
- Business process ownership
- Continuous improvement
- Risk management
- Cross-functional leadership / communication
- Executive reporting
- Problem solving
- Executive communication
Timeline
Senior Quality Technical Consultant, Global Quality & Compliance
Baxter Healthcare
02.2016 - Current
Quality Associate III – Global Quality & Compliance
Baxter Healthcare
09.2009 - 02.2016
Senior Technologist – Global R&D
Baxter Healthcare
06.2007 - 09.2009
Senior Technologist – Injectable Formulation Technology
Baxter Healthcare
04.2002 - 06.2007
Bachelor of Science - Biology
Elmhurst College