Clinical Quality Assurance Manager

We are seeking an accomplished Clinical Quality Assurance Manager to lead our Quality Assurance department and drive excellence across our global clinical trial portfolio. In this pivotal role, you will design, implement, and continuously improve our Quality Management System (QMS) while ensuring compliance with Good Clinical Practice (GCP) and all relevant local and international regulations. If you thrive in a fast-paced environment and have a passion for fostering a culture of quality, we invite you to join our innovative organization.

Responsibilities:

1. Develop, implement, and maintain a robust, risk-based Clinical Quality Management System (QMS) in line with ICH-GCP, FDA, EMA, and other applicable regulatory requirements.
2. Plan, lead, and execute internal and external GCP audits of clinical sites, vendors, and functional areas to ensure ongoing compliance.
3. Oversee the development, review, and approval of Standard Operating Procedures (SOPs) and other quality documentation.
4. Drive continuous process improvement initiatives using methodologies such as Six Sigma and Lean to enhance efficiency and quality outcomes.
5. Act as the primary QA representative during regulatory inspections, ensuring inspection readiness and prompt response to findings.
6. Collaborate cross-functionally with Clinical Operations, Regulatory Affairs, and Data Management to embed quality into all phases of clinical development.
7. Lead the investigation, root-cause analysis, and corrective and preventive action (CAPA) processes for quality events and deviations.
8. Develop and deliver GCP and quality-related training programs to internal teams and external partners.
9. Monitor quality metrics and key performance indicators,



providing regular reports and strategic recommendations to senior leadership.
10. Mentor and supervise junior QA staff, fostering a culture of accountability, continuous learning, and operational excellence.

Requirements:

1. Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field (advanced degree preferred).
2. 10–15 years of progressive experience in Clinical Quality Assurance within the pharmaceutical, biotechnology, or CRO industry.
3. Expert knowledge of ICH-GCP, FDA, EMA, MHRA, and other international clinical trial regulations and guidelines.
4. Proven track record in designing, implementing, and managing Quality Management Systems for clinical development programs.
5. Extensive experience planning and conducting GCP audits (sites, vendors, systems) and leading CAPA management.
6. Demonstrated expertise in process improvement methodologies (e.g., Six Sigma, Lean) with measurable results.
7. Strong understanding of clinical trial processes, documentation standards, and electronic systems (eTMF, CTMS, QMS).
8. Exceptional communication, presentation, and interpersonal skills with the ability to influence cross-functional stakeholders.
9. Highly analytical with solid problem-solving abilities and attention to detail.
10. Willingness to travel domestically and internationally as business needs require (up to 25%).

Nice to Have:

1. Lean Six Sigma Green or Black Belt certification.
2. Experience with digital quality management tools and data analytics platforms.
3. Previous leadership of global, multi-center clinical trial quality programs.
4. Knowledge of ISO 9001 and ISO 14155 standards.
5. Experience in biologics, advanced therapeutics, or rare disease clinical development.
6. Skilled certification such as RQAP-GCP or ASQ-CQA.
7. Proficiency in additional languages beyond English.

📌 clinical quality assurance manager (Ahmedabad)
🏢 Veeda Clinical Research
📍 Ahmedabad