Chief Quality Officer

6 days ago

Bhavnagar, Gujarat, India beBeeLeadership Full time ₹ 2,50,00,000 - ₹ 3,50,00,000
Key Leadership Role

The Head of Quality is a senior leadership position responsible for providing strategic direction and oversight to the Quality function across R&D and manufacturing operations.

Core Responsibilities
  • Strategic Direction:
    • Develop and implement a quality strategy that aligns with global regulatory requirements and organizational goals.
    • Partner with cross-functional teams to drive quality ownership, data integrity, and right-first-time execution.
  • Regulatory Compliance:
    • Maintain a robust Quality Management System (QMS) compliant with ICH, USFDA, EMA, MHRA, OECD-GLP, and cGMP requirements.
    • Oversee GMP/GLP compliance, internal audits, customer audits, and regulatory inspections.
  • Quality Assurance:
    • 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 ensure scale-up and commercial production quality.
  • Team Leadership:
    • Lead 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
    • Master's degree in Pharmaceutical Sciences / Chemistry / Life Sciences; Ph.D. preferred.
    • 20+ years of progressive QA experience in pharmaceutical / biotech / CDMO organizations, 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.

Reports to: Global Head of Quality

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