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General Manager - Corporate Quality

Sentiss Pharma Pvt. Ltd. · District de Gurgaon

Senior 🇬🇧 English
GMP Quality Management System (QMS) Analytical Method Validation

Job description

About the role

The General Manager – Corporate Quality will lead the implementation and management of the Quality Management System (QMS) across the head office, research centre and production facilities. This senior position ensures compliance in R&D, oversees quality plans at all sites, and keeps the organization aligned with current GMP and ISO standards.

Key responsibilities

  • Implement and maintain the QMS at head office, research centre and production sites.
  • Approve technical documents and ensure quality compliance in R&D activities.
  • Develop and monitor quality plans for sites, including CQA and R&D QA.
  • Lead vendor qualification and re‑qualification programmes for raw materials, consumables and contract manufacturers.
  • Coordinate ISO certification audits and ensure timely compliance.
  • Act as Management Representative for ISO standards, reporting performance metrics to top management.
  • Support internal, customer and regulatory audits at all locations.
  • Drive continuous improvement initiatives identified from audits and third‑party reviews.

Required profile

  • Master’s degree in Pharmacy (M.Pharm) or Science (M.Sc).
  • 15‑18 years of experience in quality management within the pharmaceutical or related manufacturing sector.
  • Deep knowledge of GMP, ISO standards and QMS implementation.
  • Proven ability to lead cross‑functional teams and manage complex quality projects.

Required skills

  • Good Manufacturing Practice (GMP)
  • ISO 9001 / ISO standards compliance
  • Quality Management System (QMS) implementation and oversight
  • Analytical method validation and transfer
  • Vendor qualification and re‑qualification
  • Regulatory audit management
  • Quality metrics reporting and continuous improvement

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Published 3 months ago

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Sentiss Pharma Pvt. Ltd.

District de Gurgaon