Susan Leister
Ijamsville
Summary
Performance-driven Vice President of Quality with over 25 years of experience aligning systems with business requirements, policies and regulatory requirements. Passionate about applying excellent organization and communication skills to manage and lead teams. Results-oriented individual well-versed in interfacing and consulting on business processes to drive results based on sound overall business judgment. Results driven in establishing a culture of quality.
Overview
28
28
years of professional experience
1
1
Certification
Work History
VP, Quality & Compliance
Technical Resources International, Inc.
04.2018 - Current
- Cultivates strong relationships with key internal stakeholders, including clients, vendors, and multiple regulatory agencies with long-term success.
- Chairs the Quality Management Review Meetings, Quarterly CAPA Review Meetings, serves on the Quality Committee (Council) for stakeholders, and various other strategic groups, several of which are working with industry leaders.
- Established and maintains GXP quality metrics and overall organizational metrics oversees the program
- Leads a cross-functional team for the successful completion of critical quality projects, resulting in increased efficiency and client satisfaction.
- Serves as the Industry and Federal clients as the Quality Officer, built their QMS for GMP, GLP, and GCP, manage all aspects including all regulatory inspections. Currently serve as NIH DMID QM sponsor expert and have supported multiple regulatory agency inspections.
- Oversees and manages the internal and external auditing program, as well as the software validation program
- Provides quality oversight to multiple stakeholders, (government and commerical) including internal and external audits
- Oversees 200+ audits annually by quality auditors successfully meeting timelines and preparing for regulatory agency inspections
- Manages and oversees various regulatory authority inspections (FDA, EMA, PMDA, Health Canada, MHRA, SAHPRA, BoMRA, and MFDS). Responsible for the inspection from end to end.
- Obtained and maintains the ISO 9001 certification.
- Developed new revenue streams by identifying growth opportunities and forging strategic partnerships with key industry players, expanding the quality business by over 8 million a year
- Chairs the Quality Management Review Meetings, Quarterly CAPA Review Meetings, serves on the Quality Committee (Council) for clients, and various other strategic groups, several of which are working with industry leaders.
Director of Quality Assurance
Technical Resources International, Inc.
02.2009 - 04.2018
- Developed and implemented the Quality Management System per ISO 9001 standards
- Created a culture of quality within the organization
- Developed and executed the quality audit program (internal and external) covering GMP, GLP, GCP and software for continuous process improvement and risk mitigation > 150 audits per year
- Managed CAPA resolution and customer complaints
- Responsible for all regulatory agency inspections Manages and oversees various regulatory agency inspections (FDA, EMA, PMDA, Health Canada, MHRA, SAHPRA, BoMRA, and MFDS) Responsible for the inspection from end to end
- Established and oversaw company-wide Quality Management System (QMS), maintaining compliance with 21 CFR part 11, 210, 211, 312, 820 and ICH requirements
- Created and led the corporate mentor program
- Served as the person in the plant for GMP clients
- Interfaced directly with high-level executives within client companies, addressing concerns and correcting perceived faults to maintain smooth customer relationships
- Created quality agreements and negotiated them and was the official QA signatory
- Authored the risk management program and provided training through Barnett International to various clients including many pharmaceutical organizations and biotech
- Conducted periodic performance reviews for team members, providing constructive feedback for professional growth
- Implemented auditor training program to enhance the skillset of the Quality Assurance team members
- Oversaw the software validation program and shortened overall validation turnaround times and reduced customer complaints
- Streamlined quality assurance documentation, ensuring accuracy and compliance with industry standards using lean six sigma processes.
- Converted the paper based QMS to a validated (21CFR part 11 compliant system) TrackWise
- Led an international team, fostering a culture of continuous improvement and excellence.
Senior Director of Quality Assurance Regulatory Affairs
TraumaCure Inc.
06.2006 - 02.2009
- Developed and maintained a vigilance and recall program to market a medical device in the United States, Europe, Asia, Canada, South America, Australia, and Middle East, with a focus on hemostatic agents and emergency response
- Prepared the regulatory files for the medical device to receive ISO 13485, CE Mark, and Canadian Medical Devices Conformity Assessment System (CMDCAS) licensure for a start-up company
- Responsible for FDA and ISO inspections
- Audited and monitored contract vendors and suppliers to GMP, GCP, and GLP requirements
- Prepared, launched, and maintained the QMS meeting ISO 13485 certification for compliance
- Led the Quality Committee Meetings, Product Review Board Meetings, Management Review Board Meetings, and CAPA Meetings
Director of Client Services, BD, & Recruiting
Bioanalytical Systems Inc. (BASi)
08.2005 - 06.2006
- Oversaw Clinical Study Project Manager for Phase 1 and 2 Studies ensures client deliverables were met
- Therapeutic areas included cardiovascular, pain management, infectious diseases, dermatology, and obesity
- Managed recruiting staff to locate research participants
- Increased participant database by 30% in less than 2 months, with improved recruiting techniques and marketing strategies
- Handled customer complaints, provided appropriate solutions, and alternatives within appropriate timeframes and followed up to achieve resolution.
- Built client relationships by responding to inquiries, identifying and assessing clients' needs, resolving problems, and following up with potential and existing clients.
- Prepared clinical protocols, regulatory study documentation, and clinical budgets
- Assisted in regulatory agency inspections and client audits
- Audited CLIAs and CAP laboratories for vendor qualifications.
Principal Investigator (Program Director)
McKesson Corporation
10.2003 - 05.2005
- Directed and managed a National Institutes of Health (NIH) drug repository and Research and Development (R&D) laboratory contract with a budget of ~$30M for ~75 domestic and international clinical trials
- Managed a project focused on manufacturing pharmaceutical and biological investigational products, which included identifying and auditing vendors (GMP and GLP)
- Responsible for inspections from FDA, U.S Drug Enforcement Administration (DEA), and Maryland Board of Pharmacy audits
- Audited fill and finish, packaging and labeling, laboratories, and manufacturing facilities globally
- Verified method transfer and validation of analytical methods
- Decreased shipping errors to less than 0.3 percent a year by implementing a user-friendly QC review process
- Oversaw construction of new facility and coordinated the move.
- Reviewed and approved quality agreements
- Negotiated contracts with external vendors ensuring cost-effective solutions while maintaining high standards and not compromising timelines.
Supervisor, Analytical Microbiological Laboratory
McKesson Corporation
03.2003 - 10.2003
- Oversaw daily operations of the Microbiology lab and chemists, ensuring smooth workflow and timely completion of tasks.
- Provided innovative plans for service expansion to construct the microbiology laboratory and led the construction, design, and start-up projects
- Therapeutic expertise included oncology, cardiovascular, pain management, infectious diseases, and vaccines
- Served as Project Manager for a software validation project per 21 Code of Federal Regulations (CFR) Part 11 and GAMP5
- Increased team productivity by implementing efficient workflows and setting clear expectations for staff members.
- Developed, validated, and transferred methods for stability studies
- Conducted Quality Control (QC) reviews of laboratory work, and prepared client reports
- Assisted in regulatory inspections and client audits.
- Conducted performance evaluations for staff members, identifying areas of improvement and guiding professional development plans.
- Implemented safety protocols to minimize workplace accidents and maintain compliance with industry standards.
- Identified operational inefficiencies and implemented corrective measures to increase effectiveness.
Analytical Scientist & Project Leader
McKesson Corporation
03.2001 - 03.2003
- Conducted stability studies following USP Pharmacopeia
- Developed test methods and validated them with High-Performance Liquid Chromatography (HPLC), Gas Chromatography/Mass Spectrometry (GC/MS), dissolution, Karl Fischer Solids (KFS), Total Organic Carbon (TOC), Fourier-Transform Infrared Spectroscopy (FTIR), Ultraviolet-Visible Spectroscopy (UV-VIS) following ICH and USP
- Decreased cost of hazardous waste disposal by 40+ percent using Six Sigma methodology and performance metrics
- Reviewed laboratory notebooks and prepared quarterly reports for clients
- Assisted in regulatory agency inspections and client audits.
- Reduced turnaround time for test results through the validation of automated instrumentation and software tools.
- Performed troubleshooting and maintenance tasks on laboratory equipment to minimize downtime and ensure optimal performance during experiments.
QC Shift Supervisor & Chemist
Rhodia Inc.
07.1997 - 03.2001
- Served as Laboratory Team Leader and implemented the laboratory redesign with 5S principles
- Trained new employees and delegated daily tasks and responsibilities.
- Safety Inspector for the manufacturing plant to improve near-miss-reporting for safety
- Functioned as an internal ISO 9001 auditor
- Performed HPLC, GC infrared, FTIR spectrometry, UV-VIS, wet chemistry, microbial analysis, performance testing, viscosity, and KFS for analysis of various specialty chemicals in the laboratory
- Developed, improved, transferred, and validated methods
- Prepared Standard Operating Procedures (SOPs)
- Assisted with regulatory agency inspections, ISO 9001 audits, and client audits
HazMat Operator
Compliance Innovations Inc.
08.1996 - 07.1997
- Hazardous Materials Operator at 2 U.S. Army bases
- Conducted chemical inventories of both bases and created the electronic data base
- Assisted in annual reviews and reports for chemical warfare agents
- Completed Hazwoper training and had clearance to inventory secure laboratories and facilities
Education
Ph.D. - Organization And Management
Capella University
Minneapolis, MN07.2007
MBA - Business
University of Phoenix
Phoenix, AZ06.2002
Bachelor of Science - Biochemistry And Molecular Biology
University of Maryland Baltimore County
Baltimore, MD08.1999
Skills
- Regulatory Inspection Expert
- Building & Implementation of a QMS
- Internal & External Audits
- Six Sigma Black Belt
- Client Relationship Building
- Risk Management
- Strategic Planning
- Critical Thinking
Accomplishments
- Streamlined software validation process creating SOPs, templates, and training staff reducing timelines ~40%
- Obtained and maintain ISO 9001 QMS for the organization
- Obtained and maintained ISO 13485 QMS for
- Identified key Quality opportunities and industry relationships leading to yearly revenue in excess of $8 million for a service provider
Summary of Achievements
Over 25 years of quality oversight experience in the pharmaceutical, medical device, and clinical research covering early-stage development to post approval. Currently serving as Vice President, Quality Subject Matter Expert (SME), and Lecturer. Built multiple Quality Management Systems (QMS) from the ground up with International Organization for Standardization (ISO) certification and regulatory agency inspection review. Acquired approval to sell products worldwide. Led numerous successful regulatory agency inspections including U.S. Food and Drug Administration (FDA), EMA, MHRA, PMDA, Health Canada, DEA, SAHPRA, BoMRA, Maryland Board of Pharmacy, MFDS, and Notified Bodies. Serves as Quality Risk Management subject matter.
Certification
- Certified Six Sigma Black Belt (CSSBB), ASQ (2013 to present)
- Certified Quality Auditor (CQA), ASQ (2008 to present)
- Certified Inspector, CAP
Presentations
- 04/10/2024, EQuaTR, FDA Inspections, Panel Speaker
- 04/01/2022, FDA Inspections of GMP Facilities - How to be Inspection Ready, FDAnews Webinar
- 04/12/2019, Risk management, the crash course, Association of Clinical Research Professionals (ACRP) Global Conference & Exhibition, Nashville, TN
- 04/12/2019, Unveiling the mystery of quality tolerance limits, ACRP Global Conference & Exhibition, Nashville, TN
- 03/01/2018, ICH E6 GCP interactive workshops, FDAnews
- 10/01/2018, ICH E6 GCP risk management, FDAnews Conference, Bethesda, MD
- 04/27/2018, The seismic shift in the monitoring paradigm, from QC to QA, ACRP 2018 Global Conference & Exhibition, National Harbor, MD
- 10/06/2017, ICH GCP E6 (R2) Are you ready?, Society of Clinical Research Associates (SOCRA) 26th Annual Conference, Orlando, FL
- 10/06/2017, Navigating a risk-based auditing program, SOCRA 26th Annual Conference, Orlando, FL
- 05/01/2017, Making change happen with reduced timelines, ASQ 2017 World Conference on Quality and Improvement, Charlotte, NC
- 04/28/2017, The seismic shift in the monitoring paradigm, from QC to QA, ACRP 2017 Meeting & Expo, Seattle, WA
- 09/30/2016, Tools for effective project management, SOCRA 25th Annual Conference, Montreal, QC
- 04/18/2016, Clinical trial regulatory compliance challenges in research-naïve locations, 19th Annual Conference on Vaccine Research, Baltimore, MD
- 04/26/2015, QMS for medical devices, iiBIG: 2nd Annual Clinical Study Teamwork Conference, Cary, NC
- 09/18/2015, Enhance your PM skills with quality tools, SOCRA Annual Conference, Denver, CO
- 05/17/2015, Clinical quality management systems workshop, Model Agreements & Guidelines International (MAGI) Clinical Research Conference - 2015 East, Arlington, VA
- 04/25/2015, Clinical data management system validation, ACRP Global Conference & Exhibition, Salt Lake City, UT
- 09/19/2014, FDA inspection preparedness, SOCRA 23rd Annual Conference, Orlando, FL
- 04/26/2014, An effective CAPA program, ACRP Global Conference & Exhibition, San Antonio, TX
Professional Membership
- American Society for Quality (ASQ), Senior Member (2007-Present)
- Past Chair and Nominations Chair, ASQ Section 509 (2018)
- Section-Chair, ASQ Section 509 (2017)
- Chair-Elect, ASQ Section 509 (2016)
- Industry and Professional Development Chair, ASQ Section 509 (2015)
- Certification/Examination Chair, ASQ Section 509 (2011-2014)
- Maryland Performance Excellence Award Examiner, Maryland Performance Excellence Foundation (2012-2015)
- International Team Excellence Awards Judge, ASQ (2013, 2014)
Publications
- Leister, S. (2021). Good Manufacturing Practices (GMP) [Online course]. CITI. www.citiprogram.org
- Leister, S. (2024/2025, 2020/2021). Regulations, Standards and Guidelines for Clinical Research. In Good clinical practice: a question & answer reference guide (Chapter 1). Barnett International.
- Leister, S. (2024/2025, 2020/2021, 2018, 2017, & 2016). Fraud, Negligence and Regulatory Non-compliance. In Good clinical practice: a question & answer reference guide (Chapter 16). Barnett International.
- Byrn, M. & Leister, S. (2020). FDA inspections: from site preparation to response [Online course]. CITI. www.citiprogram.org
- Leister, S. M. (2020). ICH's best practice guidelines for clinical trials gets a long-overdue update, Research Practitioner, 21(3), 45-54.
- Derr, J. & Leister, S. (2018). Comprehensive CRC Advanced [Online course]. CITI. www.citiprogram.org
- Leister, S. (2018). Risk Management in Clinical Trials: the new ICH E6 focus [eBook]. FDAnews. Leister, S. (2018). Updates to ICH E6 good clinical practice. Journal for Clinical Research Excellence, 96, 53-58.
- Leister, S. (2016). Is your CAPA system effective? Clinical Researcher, 56-60. DOI: 10.14524/CR-150020
- Leister, S. (2015). Managing and responding to FDA inspections. Applied Clinical Research, Clinical Trials & Regulatory Affairs, 2(1), 33-36. DOI: 10.2174/2212476X02666150903203830
- Leister, S. & Tran, S. (2015). To measure is to know. Quality Progress, 11(48), 41-45.
- Leister, S. & Venti, E. (2012). Good manufacturing procedure [Online course]. Regulatory Affairs Professional Society (RAPS). www.raps.org
- Leister, S. (2010). Introduction to global regulations [Online course]. RAPS. www.raps.org
- Muhr, S. (2007). Exploring job placement in the BioCapital pharmaceutical industry: a quantitative analysis. [Doctoral dissertation]. ProQuest. (Maiden name)]
Professional Development
- The Protection Human Research Subjects - Good Clinical Practice, Collaborative Institutional Training Initiative (CITI) Program (2010-Present)
- The Protection Human Research Subjects - Track 1 (biomedical), CITI (2010-Present)
- Information Security and Management: Information Security, Counterintelligence, Privacy Awareness, Records Management, and Emergency Preparedness; National Institutes of Health (NIH) (2009-Present)
- Antiharassment Training, NIH (2020-Present)
- Implicit Bias Training, NIH (2020-Present)
- Plain Language Training, NIH (2016)
- Section 508 Compliance, NIH (2016)
- Quality Risk Management in Clinical Trials and Pharmacovigilance (2013)
- Software Validation and GAMP 5 (2013)
- ASQ Six Sigma Black Belt Preparation (2012)
- ASQ The Case for Quality: Taking it to Management (2011)
- ASQ Root Cause Analysis (2011)
- A New Direction in CAPA (2007)
- BSI- ISO 13485 (2007)
- BSI CE Marking for Medical Devices (2007)
- Dealing with Difficult People (2004)
- CFPA Drug Product Stability and Shelf Life (2004)
- CFPA Vendor and Contract Supplier Qualification (2003)
- Vankel Dissolution Method Development for Pharmaceutical Dosage Forms (2002)
- Waters Method Development and Validation (2002)
Awards
- Top 500 Faculty, University of Phoenix (UOP) Phoenix 500 (2020, 2021, & 2022)
- Merit Award (DAIDS) P1090/P1093 DAIDS Registrational Team, NIH NIAID (2020)
- Merit Award (DAIDS) Dapivirine Ring Collaborative Team, NIH NIAID (2020)
- Merit Award (DAIT) NIAID CRMS Retrospective Validation Team, NIH NIAID (2020)
- NIH NCI Director's Award (2016)
- McKesson Corporate Silver Award (2005)
- McKesson Spot Award (2003, 2004)
- Sigma Rho Pi, Graduate Students Honor Society, UOP (2002)
Timeline
VP, Quality & Compliance
Technical Resources International, Inc.
04.2018 - Current
Director of Quality Assurance
Technical Resources International, Inc.
02.2009 - 04.2018
Senior Director of Quality Assurance Regulatory Affairs
TraumaCure Inc.
06.2006 - 02.2009
Director of Client Services, BD, & Recruiting
Bioanalytical Systems Inc. (BASi)
08.2005 - 06.2006
Principal Investigator (Program Director)
McKesson Corporation
10.2003 - 05.2005
Supervisor, Analytical Microbiological Laboratory
McKesson Corporation
03.2003 - 10.2003
Analytical Scientist & Project Leader
McKesson Corporation
03.2001 - 03.2003
QC Shift Supervisor & Chemist
Rhodia Inc.
07.1997 - 03.2001
HazMat Operator
Compliance Innovations Inc.
08.1996 - 07.1997
Ph.D. - Organization And Management
Capella University
MBA - Business
University of Phoenix
Bachelor of Science - Biochemistry And Molecular Biology
University of Maryland Baltimore County
- Certified Six Sigma Black Belt (CSSBB), ASQ (2013 to present)
- Certified Quality Auditor (CQA), ASQ (2008 to present)
- Certified Inspector, CAP
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