Senior Director of Quality Management

6 days ago

Rajkot, Gujarat, India beBeeQuality Full time ₹ 2,00,00,000 - ₹ 3,00,00,000
Director of Quality Assurance

The Director of Quality Assurance will provide comprehensive leadership for the quality function across research and development, manufacturing, and process operations.

Key Responsibilities
  • Strategic Leadership:
    • Develop and implement a robust quality strategy to ensure compliance with regulatory requirements and industry best practices.
    • Collaborate with global teams to align corporate and site quality standards.
    • Foster a culture of quality ownership, data integrity, and right-first-time execution.
  • Quality Systems & Regulatory Compliance:
    • Establish and maintain a compliant quality management system (QMS) that meets ICH, USFDA, EMA, MHRA, OECD-GLP, and cGMP requirements.
    • Lead audits, customer inspections, and regulatory evaluations, ensuring timely closure of observations and effective corrective actions.
    • 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 tech transfer activities from R&D to manufacturing, ensuring QbD principles and regulatory expectations are met.
    • Partner with Process R&D and Manufacturing teams to assure scale-up and commercial production quality.
  • Plant Quality Assurance:
    • Lead all plant QA functions including in-process quality checks, batch release, quality control liaison, validation, and qualification activities.
    • Ensure site readiness for all regulatory and customer inspections and maintain continuous audit readiness.
  • People & Culture:
    • Build, mentor, and develop a multi-site QA team, creating strong succession pipelines and enhancing technical capabilities.
    • Champion training programs on global quality standards, regulatory updates, and best practices.
  • Risk Management & Continuous Improvement:
    • Identify and proactively manage quality risks across R&D and manufacturing.
    • Introduce digital tools, analytics, and automation to improve compliance, efficiency, and decision-making.
    Qualifications & Experience
    • Masters degree in Pharmaceutical Sciences / Chemistry / Life Sciences; Ph.D. preferred.
    • 20+ years of progressive QA experience in pharmaceutical / biotech / CMO organisations, with at least 5–7 years in a senior leadership role.
    • Strong track record in R&D QA (Discovery & Process Research) and Manufacturing QA within a regulated environment.
    • In-depth understanding of global regulatory frameworks (USFDA, EMA, MHRA, ICH, OECD-GLP, cGMP).
    • Proven success in leading multi-location QA teams, managing customer and regulatory inspections, and implementing robust QMS.
    Key Competencies
    • Strategic Leadership & Influence – ability to shape quality vision across R&D and manufacturing.
    • Technical Expertise – mastery of QMS, regulatory compliance, and technology transfer quality controls.
    • Change & Risk Management – driving cultural change and proactive risk mitigation.
    • Collaboration & Communication – effective engagement with R&D, Manufacturing, Regulatory, and Corporate leadership.
    • Decision Making & Business Acumen – balancing regulatory rigor with operational realities.

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