Healthcare Regulatory Professional

A highly skilled Healthcare Regulatory Specialist is sought to join our organization in driving compliance and quality programs for healthcare transportation & facilities, and supporting the quality management system.

This role offers a unique opportunity to make a significant impact on ensuring processes and systems comply with regional and local regulations and customer requirements. The ideal candidate will have experience working within a warehouse environment and possess competencies in quality assurance/regulatory affairs, customer relationship management, and root cause analysis.

• Determine, implement, and promote policies and procedures for internal networks and facilities (hubs and stations) to ensure compliance with standards such as GDP, GCP, and others.
• Write and review SOPs and work instructions for transportation and fulfillment solutions pertaining to the healthcare industry.
• Implement compliance and quality programs to support local quality teams and ensure they are kept up-to-date and prepared.
• Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure.
• Develop, implement, and support the quality management system and processes, develop corresponding training programs, and act as Super User for the eQMS system.
• Provide inputs to support the design and implementation of robust internal audit processes to ensure the readiness of various functions and processes when meeting regulatory agencies and customer audits.
• Lead and support various certification audits with relevant regulatory agencies and regional certification providers.
• Operations & Customer Audit Programs: Lead regular audit programs/random checks to achieve successful audit outcomes and proper post-audit follow-up actions.
• Liaise with customers to understand quality requirements/issues/underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and support in issue resolution via conducting root cause analysis (depot).
• Liaise and consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements, and RFQ Proposals for customers.
• Validation Programs: Lead and support validation of transportation lanes and critical equipment like cold chain facilities and packaging systems.

• Bachelor's degree in Pharmacy from a reputable local institute and a pharmacist license.
• Have three to five years of relevant experience in the pharmaceutical or healthcare industry in a quality-related role.
• Experience working within a warehouse environment is highly desired.
• Have competencies in quality assurance/regulatory affairs, customer relationship management, and root cause analysis.
• Have working experience ensuring compliance in accordance with Goods Manufacturing Practice cGMP, Good Clinical Practices cGCP, Goods Distribution Practice (GDP), ISO13485 for Medical Devices, IATA CEIV, and other local certifications in a warehouse and transportation business.
• Experience in conducting external and internal audits.

• Accuracy and attention to detail which is crucial to proper compliance with regulatory and standards.
• Problem-solving skills to support customer issue resolution.
• Planning and organization skills to ensure proper audit programs are managed effectively.
• Communication skills to facilitate engagements with customers and regulatory agencies.
• Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile, or Design Thinking.
• Apply data-driven decision-making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint.