GM Quality & Regulatory Affairs - Pharmaceutical API & Intermediate

Role Overview: You will be leading the Quality and Regulatory department of the API and Intermediate business at LOXIM. Your primary focus will be on ensuring quality, compliance, and global regulatory excellence, with a hands-on approach. You are expected to align with cGMP, ICH, and international regulatory standards, strengthen systems, people, and culture. Your deep understanding of API and intermediate processes, global filing requirements, and ability to guide teams through audits, inspections, and technology transfers will be crucial. Key Responsibilities: - Lead QA, QC, Regulatory Affairs, and Compliance functions at all manufacturing sites. - Ensure 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. - Conduct regulatory, customer, and internal audits, and implement compliance actions effectively. - 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 a focus on ownership and accountability. - Represent the company before regulatory bodies, partners, and customers to enhance trust and compliance. Qualifications Required: - Over 15 years of experience in API Quality & Regulatory roles, including leadership positions. - Education: M. Pharm / M.Sc. in Chemistry or Pharmaceutical Sciences; Ph.D. preferred. About LOXIM: LOXIM, founded in 1977, combines chemistry with strategic business expertise to deliver high-quality solutions globally. Their portfolio includes APIs, Intermediates, KSM, and CMO/CDMO capabilities in the pharmaceutical industry, Dyes, and Engineering Plastics. Operating in multiple countries, they ensure seamless service and collaboration worldwide.,