Quality Assurance Director

15 hours ago

Ahmedabad, Gujarat, India beBeeAssurance Full time ₹ 6,00,000 - ₹ 8,00,000

Job Title: Quality Assurance Director

Description:

We are seeking a highly experienced and skilled Quality Assurance Director to lead our quality function. The successful candidate will provide end-to-end leadership of the quality function, ensuring that all operations meet global regulatory requirements.

Key Responsibilities:
  • Strategic Leadership
    • Define and implement a comprehensive quality strategy to ensure compliance with ICH, USFDA, EMA, MHRA, OECD-GLP and cGMP requirements.
    • Act as the primary quality representative in the leadership team and partner with Global QA to align corporate and site quality standards.
    • Drive a culture of quality ownership, data integrity, and right-first-time execution across R&D and manufacturing.
  • Quality Systems & Regulatory Compliance
    • Establish and maintain a robust Quality Management System (QMS) to comply with regulatory requirements.
    • Lead and oversee GMP/GLP compliance across laboratories and manufacturing operations.
    • Plan and manage internal audits, customer audits, and regulatory inspections, ensuring timely closure of observations and effective CAPA management.
    • Oversee change control, deviation management, OOS/OOT investigations, and document control for both R&D and manufacturing units.
  • R&D & Manufacturing Interface
    • Provide quality oversight for technical activities.

Requirements:

  • Proven experience in quality assurance leadership roles.
  • Strong understanding of regulatory requirements and industry standards.
  • Excellent communication and interpersonal skills.
  • Ability to drive cultural change and improve processes.

What We Offer:

  • A dynamic and challenging work environment.
  • Opportunities for professional growth and development.
  • A competitive salary and benefits package.

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