
Clinical Quality Assurance Compliance Lead
2 weeks ago
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:
- Focus on delivering high-quality results.
- Develop strong relationships with colleagues and stakeholders.
- Stay up-to-date with industry developments and best practices.
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