LOXIM INDUSTRIES LIMITED
Website:
loxim.com
Job details:
Title: General Manager – Quality Assurance, Quality Control & Compliance
Location: Saykha, Bharuch, Gujarat, India
Experience: 20+ Years in QA/QC leadership within APIs, pharmaceutical intermediates, or regulated pharmaceutical manufacturing environments.
Education: M. Pharm / M.Sc. in Chemistry or Pharmaceutical Sciences (Ph.D. preferred)
About Loxim:
Since 1977, LOXIM Industries Limited has built a strong global reputation in chemistry-led manufacturing, innovation, and customer partnership. From high-performance dyes and specialty chemicals to pharmaceutical intermediates, APIs, and CDMO/CMO solutions, LOXIM serves customers across global markets with a deep commitment to quality, technology, and sustainability.
With manufacturing facilities in India and offices in the USA, Germany, and Singapore, LOXIM is building a future-focused pharmaceutical business driven by science, compliance, operational excellence, and innovation.
The Role:
The General Manager – Quality Assurance, Quality Control & Compliance will play a critical leadership role in building a world-class quality and compliance organization for LOXIM’s pharmaceutical business.
This role requires a strong technical and strategic leader who can establish a culture of quality, compliance, integrity, and operational excellence across API and pharmaceutical intermediate manufacturing operations.
The ideal candidate should possess deep expertise in cGMP systems, inspection readiness, quality risk management, data integrity, and quality culture development. The role will work closely with Manufacturing, R&D, Technology Transfer, and Regulatory Affairs teams to ensure alignment between manufacturing quality systems, compliance requirements, and regulatory commitments.
Key Responsibilities:
• Lead Quality Assurance, Quality Control, and Compliance functions across manufacturing operations.
• Maintain alignment with cGMP, ICH Q7, and international quality standards.
• Strengthen Quality Management Systems (QMS) including deviations, CAPA, change control, investigations, and documentation systems.
• Ensure strong data integrity practices and inspection readiness across all quality systems and laboratories.
• Lead and support customer, certification, and regulatory inspections from a Quality and Compliance perspective.
• Drive laboratory excellence including analytical compliance, OOS/OOT investigations, stability systems, and analytical robustness.
• Collaborate with Manufacturing, R&D, and Technology Transfer teams for process validation, scale-up readiness, and commercial manufacturing support.
• Drive continuous improvement initiatives and digitalization within quality systems and laboratory operations.
• Build, guide, and mentor a high-performing quality team with strong ownership, accountability, and quality mindset.
• Establish a culture of “inspection readiness at all times” across the organization.
• Collaborate closely with Regulatory Affairs teams to ensure alignment between manufacturing quality systems and global regulatory commitments.
What We’re Looking For
• Proven exposure to USFDA, EU GMP, WHO GMP, PMDA, or other international regulatory inspections.
• Strong understanding of cGMP, ICH Q7, data integrity, quality systems, and regulatory compliance frameworks.
• Hands-on experience in handling audits, inspections, investigations, CAPA, change control, and risk management systems.
• Experience in greenfield projects, multi-product facilities, and CDMO/CMO environments will be an added advantage.
• Strong leadership presence with the ability to build high-performance teams and quality-driven culture.
• Ability to balance compliance excellence with operational agility and business growth.
Why Join LOXIM?
At LOXIM, we are building a science-driven pharmaceutical organization with strong foundations in quality, technology, innovation, and global compliance. This is an opportunity to play a leadership role in shaping the future of a growing pharmaceutical business with global ambitions.
How to Apply
Do you thrive in an environment where science, compliance, quality, and innovation come together?
We would love to hear from you.
Apply at: jobs@loxim.com
Click on Apply to know more.