Clinical Quality Assurance Compliance Lead

2 weeks ago


Jamnagar, Gujarat, India beBeeCompliance Full time ₹ 20,00,000 - ₹ 25,00,000

Clinical Quality Assurance Compliance Specialist

Job Title: Clinical Quality Assurance Compliance & Training.

This role oversees end-to-end clinical trial activities from a quality perspective, ensuring compliance with regulations and guidelines to maintain inspection/audit readiness.

The ideal candidate has 5+ years of experience in a CRO/Pharma/Biotech organization, with a strong focus on quality assurance and regulatory compliance.

Key Responsibilities:

  • Developing and implementing risk-based quality compliance approaches.
  • Conducting quality reviews of clinical trial medical science and operations-related activities.
  • Maintaining oversight of team member SOP training requirements.
  • Preparing and reviewing SOPs related to quality compliance functions.

Required Skills:

  • Strong attention to detail and ability to spot inconsistencies.
  • Good conflict management skills.
  • Experience handling audits & inspections (DCGI, US FDA).
  • Thorough knowledge of GCP guidelines, ICMR guidelines, and applicable regulations.

Preferred Skills:

  • Experience working in matrix business environments.
  • Strong track record of success demonstrated through performance ratings and/or professional accomplishments.

We Offer:

  • A dynamic work environment.
  • Ongoing training and development opportunities.
  • Collaborative teams.

How to Succeed:

  1. Focus on delivering high-quality results.
  2. Develop strong relationships with colleagues and stakeholders.
  3. Stay up-to-date with industry developments and best practices.


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