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Pharma/Healthcare SME
2 weeks ago
Job Summary:We are looking for a highly skilled Pharmaceutical Subject Matter Expert (SME) to provide deep industry knowledge and strategic guidance in pharmaceutical operations, technology, compliance, and digital transformation. The SME will work closely with cross-functional teams, helping drive innovation, regulatory adherence, and efficiency across drug development, manufacturing, supply chain, and commercial operations. Key Responsibilities:Industry Expertise & Strategic Advisory:Provide in-depth knowledge of pharmaceutical industry trends, challenges, and best practices across R&D, clinical trials, regulatory, manufacturing, and commercialization.
Advise clients on digital transformation initiatives, including AI/ML, RPA, blockchain, and IoT in pharma applications. Stay updated on evolving regulatory frameworks (FDA, EMA, HIPAA, GDPR, GAMP 5) and guide compliance strategies. Regulatory & Compliance Advisory:Ensure GxP compliance across pharmaceutical processes and IT implementations.
Support validation and qualification of systems (LIMS, CTMS, MES, QMS, ERP) to meet industry standards. Guide organizations through FDA audits, inspections, and regulatory submissions. Technology & Digital Transformation:Collaborate with IT teams to implement pharma-specific technology solutions, including cloud platforms, AI-driven drug discovery, and data analytics.
Assist in the integration of ERP, CRM, CTMS, and supply chain solutions to enhance operational efficiency. Develop strategies for data integrity, cybersecurity, and governance in pharmaceutical environments. Stakeholder Engagement & Training:Act as a trusted advisor to business leaders, R&D teams, regulatory affairs, and IT professionals.
Conduct workshops, training sessions, and knowledge-sharing initiatives to ensure alignment with best practices. Work closely with vendors, technology partners, and regulatory bodies to shape industry-compliant solutions. Required Skills & Experience:15 Years of Experience in the pharmaceutical industry with expertise in R&D, clinical trials, manufacturing, regulatory compliance, or supply chain.
Strong understanding of GMP, GCP, GDP, and GAMP 5 principles. Experience with pharma technology ecosystems, including SAP, Oracle, Veeva, Salesforce, LIMS, CTMS, MES, QMS.Familiarity with emerging technologies like AI/ML, RPA, blockchain, IoT, and cloud computing in pharma applications. Excellent communication and stakeholder management skills to bridge business and IT teams.
Preferred Qualifications:Bachelor's or Master's degree in Pharmacy, Life Sciences, Bioinformatics, or a related field. Certifications in Regulatory Compliance, GAMP, Six Sigma, or pharma technology platforms. Experience working with global pharma companies and navigating international regulatory landscapes--Thanks & RegardsHR Team
