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 preferred About LOXIM Founded in 1977, LOXIM has been at the forefront of combining chemistry with strategic business expertise to deliver high-quality solutions for global markets. Our portfolio spans APIs, Intermediates, KSM, and CMO/CDMO capabilities within the pharmaceutical industry, Dyes and Engineering Plastics. Headquartered in India , we operate across Singapore, Japan, Indonesia, Vietnam, Thailand, USA, Canada, Mexico, Honduras, Brazil, Colombia, Switzerland, Germany, Italy, Spain, France, Poland, and the Netherlands , ensuring seamless service and collaboration worldwide. The Role The General Manager – Quality & Regulatory Affairs will lead our Quality and Regulatory department of our API and Intermediate business with 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 integrity Key Responsibilities Lead 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 Knowledge Proven 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 you Apply now:
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gm- quality(woven)
1 week ago
Ahmedabad, Gujarat, India CAREER141 Full time US$ 35,000 - US$ 55,000 per yearGlobal Career Move: General Manager – Quality (Woven)Location:Dhaka, BangladeshPackage:USD 3,500 – 5,000 + Accommodation + Airfare + TransportationAbout the Employer:Be a part of a globally respected garment manufacturing powerhouse inBangladesh, known for its excellence inwoven garment production and robust compliance standards. With cutting-edge...
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GM Quality Management System
7 days ago
Ahmedabad, Gujarat, India KALPATARU PROJECTS INTERNATIONAL LIMITED Full time ₹ 15,00,000 - ₹ 25,00,000 per yearCompany DescriptionKalpataru Projects International Limited (KPIL), part of the Kalpataru Group, is a prominent global engineering and construction company with a diverse portfolio including Power Transmission & Distribution, Buildings & Factories, Water Supply & Irrigation, Railways, Oil & Gas Pipelines, Urban Mobility, Highways, and Airports. Listed on the...
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Ahmedabad, India LOXIM Industries Limited Full timeTitle: GM – Quality & Regulatory Affairs - Pharmaceutical API & IntermediateLocation: Ahmedabad, GujaratExperience: > 15 years in API Quality & Regulatory roles, including leadership positionsEducation: M. Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences); Ph.D preferredAbout LOXIMFounded in 1977, LOXIM has been at the forefront of combining chemistry...
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Ahmedabad, India LOXIM Industries Limited Full timeTitle: GM – Quality & Regulatory Affairs - Pharmaceutical API & IntermediateLocation: Ahmedabad, GujaratExperience: > 15 years in API Quality & Regulatory roles, including leadership positionsEducation: M. Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences); Ph.D preferredAbout LOXIMFounded in 1977, LOXIM has been at the forefront of combining chemistry...
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Ahmedabad, India LOXIM Industries Limited Full timeTitle: 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 preferred About LOXIM Founded in 1977, LOXIM has been at the forefront of combining...
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Ahmedabad, India LOXIM Industries Limited Full timeTitle: GM – Quality & Regulatory Affairs - Pharmaceutical API & Intermediate Experience: 15 years in API Quality & Regulatory roles, including leadership positions Education: M. Pharm / M.Chemistry or Pharmaceutical Sciences); Founded in 1977, LOXIM has been at the forefront of combining chemistry with strategic business expertise to deliver high-quality...
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Gm – quality
5 days ago
Ahmedabad, India LOXIM Industries Limited Full timeTitle: GM – Quality & Regulatory Affairs - Pharmaceutical API & IntermediateLocation: Ahmedabad, GujaratExperience: 15 years in API Quality & Regulatory roles, including leadership positionsEducation: M. Pharm / M. Sc. (Chemistry or Pharmaceutical Sciences); Ph. D preferredAbout LOXIMFounded in 1977, LOXIM has been at the forefront of combining chemistry...
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GM – Quality
4 days ago
Ahmedabad, India LOXIM Industries Limited Full timeTitle: GM – Quality & Regulatory Affairs - Pharmaceutical API & IntermediateLocation: Ahmedabad, GujaratExperience: > 15 years in API Quality & Regulatory roles, including leadership positionsEducation: M. Pharm / M.Sc. (Chemistry or Pharmaceutical Sciences); Ph.D preferredAbout LOXIMFounded in 1977, LOXIM has been at the forefront of combining chemistry...
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GM – Quality
6 days ago
ahmedabad, India LOXIM Industries Limited Full timeTitle: 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 LOXIM Founded in 1977, LOXIM has been at the forefront of combining...
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GM – Quality
6 days ago
Ahmedabad, India LOXIM Industries Limited Full timeTitle: 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 LOXIM Founded in 1977, LOXIM has been at the forefront of combining...
