GM – Quality
5 days ago
Title:GM – Quality & Regulatory Affairs (Pharmaceutical API & Intermediate) Location:Ahmedabad, Gujarat Experience:> 15 years in API Quality & Regulatory roles, including leadership positions Education:M. Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences); Ph.D preferredAbout LOXIMSince its inception in 1977,LOXIM INDUSTRIES LIMITEDhas grown to become one of India's most recognized manufacturers, known for innovation and a diverse product portfolio. Our investments in cutting-edge technology and research and development allow us to stay ahead of industry trends and adapt our products to meet the evolving needs of our customers. Fromhigh-performance dyesto APIs, intermediates, CMO & CDMO forpharmaceuticals , our products create limitless possibilities for customers worldwide. Headquartered in India, with offices strategically located in the USA, Singapore, and Germany, we ensure efficient global service.The RoleTheGeneral Manager – Quality & Regulatory Affairswill lead ourAPI and Intermediate businesswith a strong focus on quality, compliance, and global regulatory excellence. This role calls for a hands-on leader who can ensure alignment with cGMP, ICH, and international regulatory standards while strengthening systems, people, and culture. The ideal candidate brings deep understanding of API and intermediate processes, global filing requirements such as DMF and CEP, and the ability to guide teams through complex audits, inspections, and technology transfers with confidence and integrityKey ResponsibilitiesLead QA, QC, Regulatory Affairs, and Compliance functions across all manufacturing sites. Maintain full alignment with cGMP, ICH Q7, and international quality standards. Strengthen the Quality Management System (QMS) with robust processes for deviation, CAPA, and change control. Manage DMF, CEP, and global regulatory submissions, renewals, and customer documentation. Lead regulatory, customer, and internal audits, ensuring timely and effective compliance actions. Collaborate with R&D, Technology Transfer, and Manufacturing teams for process validation and scale-up readiness. Drive continuous improvement initiatives and digitalization in quality systems. Build, guide, and empower a high-performing Quality & Regulatory team with strong ownership and accountability. Represent the company before regulatory bodies, partners, and customers to reinforce trust and compliance.Skills and KnowledgeProven exposure to USFDA / EMA / PMDA / WHO inspections. Hands-on experience in handling regulatory audits, submissions, and correspondence with global health authorities Experience in greenfield setups, multi-product facilities, and contract manufacturing (CMO/CDMO) environments is an advantage. Strategic thinker who balances compliance with business agility. Strong leadership and communication skills with a passion for quality excellence.Do you thrive in a fast-paced environment where precision, compliance, and innovation intersect?If so, we’d love to meet youApply now:jobs@loxim.com
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