Principal Quality Assurance Specialist (Pharmaceutical)

About the Role Our client, a respected pharmaceutical company dedicated to quality and compliance, is seeking an accomplished Principal Quality Assurance Specialist to join their expanding team, operating remotely with potential for occasional site visits to Randburg, Gauteng. This senior-level role is crucial for ensuring that all pharmaceutical products meet the highest standards of safety, efficacy, and regulatory compliance. The Principal QA Specialist will be responsible for developing, implementing, and maintaining the company's Quality Management System (QMS), conducting internal and external audits, and providing expert guidance on quality-related matters. This position demands a profound understanding of global regulatory landscapes, including FDA, EMA, and local South African regulations. We are looking for a proactive, detail-oriented professional with a strong ethical compass and the ability to influence quality culture across the organization. This is a fantastic opportunity for an experienced QA professional to lead initiatives and drive quality excellence in a remote-first capacity. Key Responsibilities Develop, implement, and manage the comprehensive Quality Management System (QMS) for pharmaceutical operations. Conduct regular internal audits and lead external audits of suppliers, contract manufacturers, and partners. Review and approve key quality-related documents, including SOPs, validation protocols, batch records, and change controls. Investigate deviations, non-conformances, and customer complaints, implementing corrective and preventive actions (CAPAs). Ensure compliance with cGMP, ICH guidelines, and all applicable international and local pharmaceutical regulations. Provide expert guidance and training on quality assurance principles and regulatory requirements to internal teams. Participate in regulatory inspections and manage responses to regulatory authorities. Lead continuous improvement initiatives aimed at enhancing product quality and process compliance. Monitor and report on key quality metrics and performance indicators to senior management. Contribute to the risk assessment and management processes for products and processes. Requirements Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related scientific field. Minimum of 10-12 years of progressive experience in Pharmaceutical Quality Assurance/Quality Control. Extensive knowledge of cGMP, GDP, and relevant pharmaceutical regulatory guidelines (FDA, EMA, SAHPRA). Proven experience in conducting internal and external audits and managing CAPA systems. Strong understanding of pharmaceutical product lifecycle and manufacturing processes. Excellent document review and approval skills, with exceptional attention to detail. Superior analytical, problem-solving, and critical thinking abilities. Outstanding written and verbal communication and interpersonal skills. Demonstrated ability to lead and influence teams in a remote work setting. Experience with electronic QMS (eQMS) software is highly desirable. Benefits Our client offers a competitive salary, comprehensive benefits package including health, dental, and vision insurance, a retirement savings plan, and generous paid time off. As a Principal QA Specialist operating remotely, you will enjoy the flexibility of working from home while contributing to critical quality functions for a respected pharmaceutical organization. We provide opportunities for continuous learning and professional growth, fostering an environment where your expertise in quality assurance is valued and impactful. Opportunities for occasional travel to our Randburg, Gauteng facilities may arise for critical meetings or audits. #J-18808-Ljbffr Placements24