Lead Clinical Quality Assurance Specialist

23 hours ago

Solapur, Maharashtra, India beBeeCompliance Full time ₹ 80,00,000 - ₹ 1,20,00,000

Clinical Quality Assurance Lead

This senior position oversees all aspects of clinical trial quality assurance, ensuring compliance with regulatory requirements and best practices.

  • Develops and implements risk-based quality compliance strategies to safeguard trial participants and data.
  • Establishes procedures for team training, ensuring protection of human subjects and data integrity.
  • Prepares and reviews SOPs related to quality control, medical science, and data management.
  • Conducts quality reviews of clinical trial activities, including synopsis, protocol, and CSR.

Requirements:

  • 5+ years' experience in a CRO/Pharma/Biotech organization, specifically in the quality department.
  • Strong attention to detail and conflict management skills.
  • Experience handling audits and inspections from DCGI and US FDA.
  • Thorough knowledge of GCP guidelines, ICMR regulations, and other applicable laws.
  • Matrix business environment experience preferred.

A strong track record of success is essential for this role. A successful candidate will have a deep understanding of quality assurance principles and practices, as well as excellent leadership and communication skills.

About the Role:

  • This role will work closely with cross-functional teams to develop and implement quality compliance strategies.
  • The ideal candidate will have a proven track record of delivering high-quality results in a fast-paced environment.
  • This is an exciting opportunity for a seasoned professional to take on a challenging leadership role and make a meaningful impact.

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