General Manager Quality

3 weeks ago

Bavla, India Umendra Life Sciences Full time

At Umendra Life Sciences Pvt. Ltd., we take quality seriously. Our products are trusted by consumers worldwide, and were looking for a Quality Control (QC)/Quality Assurance professional to ensure they meet the highest standards. If you're passionate about precision and excellence, this role is for you.Your Role:

As a key member and head of the Quality team, you will lead critical functions & vendor qualification approval across compliance, validation, audits, vendor qualification, and quality systems implementation. Your focus will be to proactively establish and monitor strong quality assurance processes to ensure regulatory compliance and audit readiness. You will be heading the entire quality function & will be responsible for the overall QMS at the factory.

Key Responsibilities:

  • Lead the development, implementation, and continuous improvement of the companys Quality Management System (QMS) in accordance with cGMP, ISO, and relevant regulatory standards.
  • Manage and oversee QA, QC, and Micro operations, ensuring stringent quality checks across raw materials, in-process, and finished products.
  • Ensure full compliance with applicable national and international regulatory requirements (CDSCO, WHO-GMP, USFDA, EU, etc.).
  • Direct and manage internal/external audits and regulatory inspections and facilitate timely resolution of observations through a robust CAPA system.
  • Approve SOPs, technical documents, batch records, and validation protocols; ensure timely updates and training across teams.
  • Drive root cause analysis, deviation management, change controls, and implementation of preventive actions.
  • Guide the Quality teams in establishing good documentation practices, good laboratory practices (GLP), and robust release procedures.
  • Work collaboratively with cross-functional teams including Production, R&D, Regulatory Affairs, and Supply Chain to align quality goals with business objectives.
  • Provide regular quality performance updates and risk assessments to the senior leadership.
  • Build and lead a high-performing quality team; mentor and train staff to enhance technical competencies and compliance awareness.
  • Exposure to various audits and comprehensive understanding od USFDA CFR21 is mandatory.

Qualifications & Experience:

  • Bachelor's or Masters degree in Pharmacy, Chemistry, or relevant scientific discipline
  • years of experience in heading Quality in a regulated pharmaceutical manufacturing environment.
  • Strong working knowledge of GMP, compliance protocols, validation (CSV), regulatory audit
  • Experience working with FDA, EU, and CDSCO regulations.
  • USFDA audit exposure
  • Proficient in documentation and quality tools (MS Office, QMS software).

Join us in delivering safe, effective, and high-quality personal care products that people trust.

This is a senior management position with overall responsibility of the Quality vertical.

Note: Candidates from Ahmedabad, Varodara, ankleshwar,Surat,Bharuch, Mehsana, Dahej and Surendranager are Preferred

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