Association of Regulatory Compliance Behaviour with HR Compliance Training and Quality Assurance Enforcement in the Saudi Pharmaceutical Sector: Testing Vision 2030-Driven Healthcare Innovation Capability as a Moderator

Authors

  • Saleem Raza Bhatti Department of Business Administration, Emaan Institute of Management and Sciences, Karachi, Pakistan

DOI:

https://doi.org/10.65080/ajbmss.v2i2.CMT2622101006

Keywords:

HR compliance training, quality assurance enforcement, regulatory compliance behaviour, pharmaceutical industry, vision 2030-driven healthcare innovation capability, Saudi Arabia

Abstract

Introduction: This study explored the association between HR compliance training and quality assurance enforcement with regulatory compliance behaviour among the Saudi pharmaceutical industry and how Vision 2030-driven healthcare innovation capabilities moderate this association.

Methodology: Data were gathered using a structured questionnaire completed by 400 HR compliance officers and quality assurance managers. Partial least squares structural equation modelling (PLS-SEM) was used to test the hypothesised relationships. The findings indicate that regulatory compliance behaviour is associated with HR compliance training (β = 0.380, p = 0.001), but quality assurance enforcement does not show a significant association with regulatory compliance behaviour (β = 0.074,  p= 0.313). Vision 2030-driven healthcare innovation capability had a marginally significant moderating impact only on the association between HR compliance training and compliance behaviour (β = 0.121, p = 0.050), but not on quality assurance enforcement and HR compliance training (β = 0.004, p = 0.942).

Results: The results showed that capability-building mechanisms might be a relatively more effective predictor of compliance behaviour than structural enforcement mechanisms, but the effect sizes were relatively small.

Conclusion: The findings of this research have practical implications for informing the design of training and maximising compliance outcomes by capitalising on digital innovation.

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References

Aburumman, O. J., Omar, K., Al Shbail, M., & Aldoghan, M. (2022). How to deal with the results of PLS-SEM?. In International Conference on Business and Technology (pp. 1196-1206). Cham: Springer International Publishing.

https://doi.org/10.1007/978-3-031-08954-1_101

Adola, T. B., Assefa, D., Ejeta, F., Gashe, F., Paulos, G., & Borga, D. K. (2026). Assessment of current good manufacturing practice (cGMP) compliance in pharmaceutical manufacturers in Ethiopia: Cross-sectional descriptive study. PloS One, 21(3), e0343881. https://doi.org/10.1371/journal.pone.0343881

Altamuro, J. L. M., Gray, J. V., & Zhang, H. (2022). Corporate integrity culture and compliance: A study of the pharmaceutical industry. Contemporary Accounting Research, 39(1), 428-458.

https://doi.org/10.1111/1911-3846.12727

Anbil, P., Deshpande, P. & Khot, P. (2026). Quality and Compliance in the Pharmaceutical Industry: Navigating a Transformed Landscape. Pharmaceutical Commerce. 21(1). Available from: https://www.pharmaceuticalcommerce.com/view/quality-and-compliance-in-the-pharmaceutical-industry (Accessed on: 03-08-2026).

Arab, O. O., Aldayan, M., Almowaizri, K., Alghamdi, A., Alghamdi, J., & Alharf, A. (2025). Descriptive Analysis of Good Clinical Practice Inspection Findings from the Saudi Food and Drug Authority. Therapeutic Innovation & Regulatory Science, 59, 295–303. https://doi.org/10.1007/s43441-024-00731-5

Bao, Y., Buhay, N. & Zheng, Q. (2024). A Dynamic Model for GMP Compliance and Regulatory Science. Journal of Pharmaceutical Innovation, 19. 25. https://doi.org/10.1007/s12247-024-09825-x

Barney, J. B. (2001). Resource-based theories of competitive advantage: A ten-year retrospective on the resource-based view. Journal of Management, 27(6), 643-650. https://doi.org/10.1177/014920630102700602

Bernasconi, M., Friedli, T., & von Dzengelevski, O. (2025). The impact of current good manufacturing practices inspections on continuous improvement mindset in the pharmaceutical industry. Journal of Pharmaceutical Innovation, 20, 282. https://doi.org/10.1007/s12247-025-10200-7

Campbell, S., Greenwood, M., Prior, S., Shearer, T., Walkem, K., Young, S., ... & Walker, K. (2020). Purposive sampling: complex or simple? Research case examples. Journal of Research in Nursing, 25(8), 652-661.

https://doi.org/10.1177/1744987120927206

Chen, H., Qin, L., Jiang, C., Qin, M., Sun, Y., & Luo, J. (2023). Characteristics, risk management and GMP standards of pharmaceutical companies in China. Frontiers in Public Health, 11, 1103555.

https://doi.org/10.3389/fpubh.2023.1103555

Colman, H. (2026). HR Compliance Training: A Practical Guide for 2026. iSpring LMS. Available from: https://www.ispring.com/knowledge-hub/hr-compliance-training (Accessed on: 03-08-2026).

Conrad, J., Silver, P., & Elsner, N. (2019). Maintaining value in pharmaceutical compliance. Deloitte Insights. Available from: https://www.deloitte.com/us/en/insights/industry/life-sciences/pharmaceutical-compliance-technology.html (Accessed on: 03-08-2026).

Cuffari, B. (2025). Market Report 2025: Pharmaceutical Manufacturing. News-Medical Life Sciences. Available from: https://www.news-medical.net/life-sciences/Market-Report-2025-Pharmaceutical-Manufacturing.aspx

Fellows, M., Friedli, T., Li, Y., Maguire, J., Rakala, N., Ritz, M., Bernasconi, M., Seiss, M., Stiber, N., Swatek, M., & Viehmann, A. (2022). Benchmarking the quality practices of global pharmaceutical manufacturing to advance supply chain resilience. The AAPS Journal, 24(6), 111. https://doi.org/10.1208/s12248-022-00761-7

Ghanad, A. (2023). An overview of quantitative research methods. International Journal of Multidisciplinary Research and Analysis, 6(08), 3794-3803. https://doi.org/10.47191/ijmra/v6-i8-52

Gillani, A. H., Arshad, H., Yang, C., Arshed, M., Atif, N., Bashir, K., Abbas Malik, H. M., & Fang, Y. (2025). Assessing the effects of online educational intervention on pharmaceutical promotions: a pre-post study among medical and pharmacy students in Pakistan. Frontiers in Pharmacology, 16, 1616631. https://doi.org/10.3389/fphar.2025.1616631

Global Health Exhibition (2024). How Saudi’s Vision 2030 is going to Transform the Healthcare Industry. Available from: https://www.globalhealthsaudi.com/en/news/healthcare-insights/how_saudis_vision_2030_is_going_to_transform_the_healthcare.html (Accessed on: 03-08-2026).

Hair, J., & Alamer, A. (2022). Partial Least Squares Structural Equation Modeling (PLS-SEM) in second language and education research: Guidelines using an applied example. Research Methods in Applied Linguistics, 1(3), 100027.

https://doi.org/10.1016/j.rmal.2022.100027

Jacobs, A. (2023). Why compliance training fails. SSRN. https://dx.doi.org/10.2139/ssrn.5268898

Jessica, R. (2025). Navigating the complex world of pharma regulatory compliance: Finding the sweet spot between safety & innovation. Available from: https://gmppros.com/pharma-regulatory-compliance/ (Accessed on: 03-08-2026).

Julian, C., & Abbas, A. (2020). Regulatory Compliance in HR: A Strategic Workforce Planning Approach. ResearchGate.

https://doi.org/10.13140/RG.2.2.19928.76806

Khaliq, S. A., Kashif, M., Shaik, M. J., & Hussain, I. (2025). A narrative review on automation and digitalization in quality control laboratories of pharmaceuticals. International Journal of Pharmacy & Integrated Health Sciences, 6(2), 89-98.

https://doi.org/10.56536/ijpihs.v6i2.262

Klein, T. A., Seelbach, C. L., & Brannan, G. D. (2023). Quality Assurance. PubMed; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK557503/ (Accessed on: 03-08-2026).

Kuiper, M. E. (2025). There is no quick fix: Compliance officers’ views on organisational behavioural change. Journal of Business Ethics, 206, 461-486. https://doi.org/10.1007/s10551-025-06183-7

Manor, K. (2025). Is a compliance training program effective? A comparison analysis of compliance officers' perceptions and recommended practices in multinational corporations regarding compliance etraining program effectiveness. Journal of Legal, Ethical & Regulatory Isses, 28 (2). https://doi.org/10.13140/RG.2.2.35961.38245

Muhammad, F., Iqbal, N., Asim, M., & Ali, M. A. (2025). Impact of training program components on perceived training utility and cGMP compliance behaviour: An evidence from pharmaceutical industry (Pakistan). Journal of Asian Development Studies, 14(4), 209-224. https://doi.org/10.62345/jads.2025.14.04.1661

Rahman, M. M. (2023). Sample size determination for survey research and non-probability sampling techniques: A review and set of recommendations. Journal of Entrepreneurship, Business and Economics, 11(1), 42-62. Available from: https://scientificia.com/index.php/JEBE/article/view/201/190 (Accessed on: 03-08-2026).

Rasoolimanesh, S. M. (2022). Discriminant validity assessment in PLS-SEM: A comprehensive composite-based approach. Data Analysis Perspectives Journal, 3(2), 1-8. https://www.researchgate.net/profile/S-Mostafa-Rasoolimanesh/publication/356961783_Discriminant_validity_assessment_in_PLS-SEM_A_comprehensive_composite-based_approach/links/61b465e31d88475981dfde95/Discriminant-validity-assessment-in-PLS-SEM-A-comprehensive-composite-based-approach.pdf (Accessed on: 03-08-2026).

Saudi Food and Drug Authority (2026). SFDA conducts field visits to 197 pharmaceutical, medical device factories in 2023. Available from: https://www.sfda.gov.sa/en/news/878322 (Accessed on: 03-08-2026).

Saudi Gazette (2024). SFDA slaps fines of SR678400 on 24 pharmaceutical firms for violations. Available from: https://saudigazette.com.sa/article/645811/SAUDI-ARABIA/SFDA-slaps-fines-of-SR678400-on-24-pharmaceutical-firms-for-violations (Accessed on: 03-08-2026).

Science & Innovation Network (2022). UK Science & Innovation Network Country Snapshot Kingdom of Saudi Arabia. Available from: https://assets.publishing.service.gov.uk/media/6391ae8fd3bf7f1bd42de7be/KSA_Snapshot-2022.pdf (Accessed on: 03-08-2026).

SFDA (2025). SFDA GMP inspection deficiency data trend 2025. Available from: https://www.sfda.gov.sa/sites/default/files/2026-03/DF2025.pdf (Accessed on: 03-08-2026).

Teece, D. J. (2022). The evolution of the dynamic capabilities framework. In Artificiality and Sustainability in Entrepreneurship: Exploring the unforeseen, and paving the way to a sustainable future. FGF Studies in Small Business and Entrepreneurship. (pp. 113-129). Cham: Springer International Publishing.

https://doi.org/10.1007/978-3-031-11371-0_6

Ullagaddi, P. (2024). Leveraging digital transformation for enhanced risk mitigation and compliance in pharma manufacturing. Journal of Advances in Medical and Pharmaceutical Sciences, 26(6), 75-86.

https://doi.org/10.9734/jamps/2024/v26i6697

Waheed, A., Waheed, S., Hussain, S., & Majeed, A. (2024). The HR revolution: Redefining performance paradigms in Pakistan's pharma landscape through moderating role of innovative climate. PloS One, 19(5), e0301777.

https://doi.org/10.1371/journal.pone.0301777

WHO (2023). Saudi Arabia regulatory system becomes third to reach WHO Maturity Level 4. Available from: https://www.who.int/news/item/30-10-2023-saudi-arabia-regulatory-system-becomes-third-to-reach-who-maturity-level-4 (Accessed on: 03-08-2026).

Zubair, M. (2024). Navigating the complex landscape of regulatory compliance in the pharmaceutical industry. Trends in Telemedicine & E-health, 5(2). http://dx.doi.org/10.31031/TTEH.2024.05.000607

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Published

2026-08-27

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How to Cite

Association of Regulatory Compliance Behaviour with HR Compliance Training and Quality Assurance Enforcement in the Saudi Pharmaceutical Sector: Testing Vision 2030-Driven Healthcare Innovation Capability as a Moderator. (2026). AJBMSS - Advance Journal of Business Management and Social Sciences, 2(2), 1-16. https://doi.org/10.65080/ajbmss.v2i2.CMT2622101006