Quality Management Soft Skills

• Ada Lovelace Institute. (2022). What is a foundation model?
• 19th Century. (n.d.). Ada Lovelace: 19th-century mathematician.
• Amplelogic. (2022). Continuous quality improvement for life sciences industry.
• ASQ. (n.d.). Plan-Do-Check-Act (PDCA) cycle.
• Britannica. (n.d.). Ada Lovelace.
• Deloitte. (2023). Digital transformation in life sciences.
• Deloitte. (2023). Biopharma digital transformation.
• Fahmi, G. (2022). Transforming life sciences quality management: A modern approach.
• International Organization for Standardization. (n.d.). ISO 9000 family—Quality management.
• LNS Research. (2023). Driving new organizational models in life sciences.
• McKinsey & Company. (2022). Five ways that life sciences companies can build tech talent.
• McKinsey & Company. (2023). The technology imperative for life sciences.
• Prosci. (n.d.). The ADKAR® model.
• TDWI. (2023). Integration of eQMS in life sciences organizations.
• The History Ace. (n.d.). Ada Lovelace: 3 impacts from the world’s first programmer.
• U.S. Food and Drug Administration. (2003). Part 11, electronic records; electronic signatures—Scope and application.
• Scilife. (2023). Digital transformation in life sciences.
• Scilife. (n.d.). Risk-based thinking to manage nonconformities and deviations.

• American Society for Quality (ASQ). (n.d.). Failure modes and effects analysis (FMEA).
• American Society for Quality (ASQ). (n.d.). Fishbone diagram (Cause and effect analysis).
• American Society for Quality (ASQ). (n.d.). PDCA cycle.
• American Society for Quality (ASQ). (n.d.). The five whys.
• Britannica. (n.d.). Leonardo da Vinci: Second Florentine period (1500–08).
• Critical Thinking Foundation. (n.d.). Defining critical thinking.
• Food and Drug Administration (FDA). (2022). Computer software assurance for production and quality system software.
• Food and Drug Administration (FDA). (2023). Current good manufacturing practice (CGMP) regulations.
• Food and Drug Administration (FDA). (2023). Part 11: Electronic records; electronic signatures - Scope and application.
• Food and Drug Administration (FDA). (2023). Quality system (QS) regulation/medical device current good manufacturing practices (CGMP).
• The FDA Group. (n.d.). Computer system validation.
• International Society for Pharmaceutical Engineering (ISPE). (2022). GAMP 5: A risk-based approach to compliant GxP computerized systems (2nd ed.).
• Regulatory Affairs Professionals Society (RAPS). (2023). Importance of critical thinking in regulatory intelligence.
• Scilife. (n.d.). Human error: Root cause analysis in life sciences.

• American Society for Quality (ASQ). (n.d.). Plan-Do-Check-Act (PDCA) cycle.
• Bridges, W. (n.d.). Bridges’ transition model.
• Change Management Insight. (n.d.). Satir change management model.
• Elisabeth Kübler-Ross Foundation. (n.d.). Change curve.
• Harvard Business Review. (2011). Adaptability: The new competitive advantage.
• Kotter, J. (n.d.). 8-step process for leading change.
• McKinsey & Company. (2009). The irrational side of change management.
• McKinsey & Company. (2019). Five moves to make during a digital transformation.
• McKinsey & Company. (2024). The adaptability advantage: How to thrive in a changing world.
• McKinsey & Company. (n.d.). Enduring ideas: The 7-S framework.
• MindTools. (n.d.). Lewin’s change management model.
• Pasteur, L. (1880). Studies on fermentation: The diseases of beer, their causes, and the means of preventing them.
• Prosci. (n.d.). The ADKAR model overview.
• Prosci. (2018). Change management ROI calculation.

• ASQ. (n.d.). Nominal group technique.
• ASQ. (n.d.). PDCA cycle.
• Biography. (n.d.). Jonas Salk - Polio Vaccine, Discovery & Quotes.
• BMC Public Health. (2020). A multi-pronged scoping review approach to...
• Inside Salk. (2020). Leading Salk science into the future.
• Interaction Design Foundation. (n.d.). Learn how to use the best ideation methods: SCAMPER.
• Kotter Inc. (n.d.). The 8-step process for leading change.
• New Yorker. (2015). The last time a vaccine saved America.
• PLoS Global Public Health. (2022). Facilitators and barriers to community engagement in the Global Polio Eradication Initiative.
• Quality Gurus. (n.d.). RACI matrix: How to use it and its benefits.
• Quality Sifu. (n.d.). How to get started with SMART goals for quality assurance.
• Salk Institute. (n.d.). About Jonas Salk.
• ThoughtCo. (n.d.). Biography of Jonas Salk: Inventor of the polio vaccine.
• Time. (2015). Vaccine history and Jonas Salk: 5 things you may not know.

Allen, D. (2024). What is GTD? Retrieved from https://gettingthingsdone.com/what-is-gtd/

Atlassian. (n.d.). What is Agile? Retrieved from https://www.atlassian.com/agile

Cirillo, F. (n.d.). The Pomodoro® Technique. Retrieved from https://www.pomodorotechnique.com/

D'Hombres, E. (2016). The Darwinian muddle on the division of labour: An attempt at clarification. History and Philosophy of the Life Sciences, 38(1), 1–22. https://doi.org/10.1007/s40656-015-0090-x

Darwin, Then and Now. (n.d.). Understanding Evolution. Retrieved from https://darwinthenandnow.com/understanding-evolution/

Darwin Correspondence Project. (n.d.). Darwin and Working from Home. Retrieved from https://www.darwinproject.ac.uk/commentary/curious/darwin-and-working-home

Francois, E. (2023). A glimpse into my daily routine as a QA manager. Medium. Retrieved from https://emilefrancois.medium.com/a-glimpse-into-my-daily-routine-as-a-qa-manager-03afcb019276

Hyatt, M. (2019). Free to focus: A total productivity system to achieve more by doing less. Baker Books.

McKinsey & Company. (2021). Making quality assurance smart. Retrieved from https://www.mckinsey.com/industries/life-sciences/our-insights/making-quality-assurance-smart

Scrum.org. (n.d.). What is Scrum? Retrieved from https://www.scrum.org/resources/what-scrum-module

SciLife. (2021). Essentials of quality management in the life sciences. Retrieved from https://www.scilife.io/blog/essentials-quality-management-life-sciences

SciLife. (2021). Quality concepts: A comprehensive guide. Retrieved from https://www.scilife.io/blog/quality-concepts-guide

Stanford Encyclopedia of Philosophy. (2019). Darwin: From the Origin of Species to the Descent of Man. Retrieved from https://plato.stanford.edu/entries/origin-descent/

The Week Staff. (2017). Why you should work 4 hours a day, according to science. The Week. Retrieved from https://theweek.com/articles/696644/why-should-work-4-hours-day-according-science

Wolfe, J. (2024). Charles Darwin. Encyclopaedia Britannica. Retrieved from https://www.britannica.com/biography/Charles-Darwin

American Society for Quality. (n.d.). Continuous improvement. ASQ. Retrieved from https://asq.org/quality-resources/continuous-improvement

Ambrosia Ventures. (2023). Quality unleashed: Ensuring excellence in life sciences through robust quality assurance. https://www.ambrosiaventures.co/post/quality-unleashed-ensuring-excellence-in-life-sciences-through-robust-quality-assurance

BMC Health Services Research. (2024). A scoping review of continuous quality improvement in healthcare system: conceptualization, models and tools, barriers and facilitators, and impact. BMC Health Services Research. https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-024-10828-0

BMC Medical Education. (2024).Implementing learning into practice from continuous professional development activities: a scoping review of health professionals’ views and experiences. BMC Medical Education. https://bmcmededuc.biomedcentral.com/articles/10.1186/s12909-024-06016-7

BMC Nursing. (2021). Lifelong learning and nurses’ continuing professional development, a metasynthesis of the literature. BMC Nursing. https://bmcnurs.biomedcentral.com/articles/10.1186/s12912-021-00579-2

Cartwright, M. (2009). Hypatia of Alexandria. In World History Encyclopedia. Retrieved from https://www.worldhistory.org/Hypatia_of_Alexandria/

Duignan, B. (2024). Hypatia. In Encyclopaedia Britannica. Retrieved from https://www.britannica.com/biography/Hypatia

History and Artifacts. (2024). Hypatia of Alexandria: A beacon of knowledge in ancient Egypt. https://historyandartifacts.com/hypatia-of-alexandria-a-beacon-of-knowledge-in-ancient-egypt/

LinkedIn Continuous Improvement. (2024). The importance of continuous improvement in life sciences. https://www.linkedin.com/pulse/importance-continuous-improvement-life-sciences-its-impact-pedroza-vsh8c/

LinkedIn QA Team Development. (2024). Develop and motivate your QA team. https://www.linkedin.com/pulse/develop-motivate-retain-your-qa-team-strategies-life-sciences-dmdaf/

QASE. (2024). Continuous learning mindset in QA. https://qase.io/blog/continuous-learning-mindset-qa/

Verista. (2023). Training in life sciences: The underdog of quality. https://verista.com/training-in-life-sciences-the-underdog-of-quality-part-1/