Job Title

Regulatory Compliance Ensure site-wide compliance with all applicable regulations, including cGMP, FDA, EMA, MHRA, and other global regulatory standards for sterile manufacturing. Maintain up-to-date knowledge of regulatory changes, guidance documents, and industry trends to ensure ongoing compliance. Act as the site subject matter expert for audit and compliance-related matters. Audit Management Plan, lead, and execute internal audits to assess compliance with SOPs, quality systems, and regulatory requirements. Develop and maintain an annual audit program covering all operational, manufacturing, laboratory, engineering, and quality systems. Introduce and conduct random, unannounced audits focusing on critical areas such as aseptic practices, cleanliness, documentation, data integrity, and critical equipment. Perform real-time reviews of batch records, validation protocols, and production practices to ensure compliance. External Audits & Inspections Manage and coordinate audits and inspections conducted by regulatory authorities, customers, and third-party auditors. Prepare the site for regulatory and customer audits, including readiness assessments, mock inspections, and staff training. Lead responses to audit observations and inspection findings, including regulatory commitments. Track, manage, and ensure timely closure of audit observations, CAPAs, and effectiveness checks. Compliance Monitoring & Walk-Throughs Conduct regular and unscheduled compliance walk-throughs to assess facility conditions, aseptic behaviors, documentation practices, and safety compliance. Use walk-throughs as an opportunity to engage with site personnel and reinforce a culture of compliance and quality ownership. Risk Management & Continuous Improvement Identify potential quality and compliance risks and implement appropriate risk mitigation strategies. Drive continuous improvement initiatives to enhance compliance, reduce deviations, and improve overall quality performance. Lead initiatives to streamline processes and strengthen inspection readiness in sterile manufacturing operations. Cross-Functional Collaboration & Communication Collaborate closely with Manufacturing, Engineering, R&D, Quality Control, Procurement, and Supply Chain to ensure compliance expectations are understood and upheld. Serve as the primary liaison between the site and corporate headquarters for all audit and compliance-related activities. Act as the point of contact for compliance issues within the plant and lead compliance-related meetings. Reporting & Stakeholder Management Provide regular compliance status reports, audit metrics, and risk assessments to senior management. Communicate effectively with customers and external stakeholders regarding compliance-related topics, audits, and updates.Qualifications & Experience Bachelor’s or Master’s degree in Pharmacy, or a related field. 8–12+ years of experience in Quality, Compliance, or Audit roles within sterile pharmaceutical manufacturing. Strong knowledge of cGMP regulations and regulatory expectations for aseptic processing. Proven experience leading regulatory inspections (FDA, EMA, MHRA) and customer audits. Hands-on experience with internal audits, CAPA management, and inspection readiness.