Takeda: Sr Clinical Quality Specialist, Mumbai

Takeda, a global leader in biopharmaceuticals, is hiring for the role of Senior Clinical Quality Specialist in Mumbai, India. This position is designed for experienced professionals in clinical quality assurance, GCP compliance, and clinical trial management. With a strong focus on regulatory compliance, risk management, and supplier audits, this role offers the chance to make a significant impact in ensuring patient safety and data integrity.

If you have 7–10 years of experience in the clinical trial industry as a Clinical Quality Auditor, this could be the next big step in your career.

🔎 Key Responsibilities

• Develop and implement Clinical Quality Assurance (CQA) procedures and local Quality Management Systems (QMS).
• Conduct internal, external, and site audits to ensure compliance with ICH GCP guidelines.
• Establish and maintain a local risk register and risk monitoring program.
• Provide independent quality oversight for GCP suppliers, including Quality Agreements and governance.
• Manage Quality Incident Notifications, deviations, CAPAs, and compliance risks.
• Support regulatory inspections, Takeda audits, and supplier audits.
• Ensure training management through Takeda’s LMS for local GxP staff.
• Represent Takeda in communication with local regulatory authorities on GCP matters.

🎓 Qualifications & Skills

• Life Sciences Graduate/Postgraduate (Pharma, Biotech, Clinical Research preferred).
• 7–10 years’ experience in clinical trials, specifically as a Clinical Quality Auditor.
• Strong knowledge of ICH E6, ICH E3, ICH E8, ICH E9 guidelines and cGxPs.
• Excellent communication, negotiation, and stakeholder management skills.
• Proven expertise in risk management, problem-solving, and audit execution.
• Fluency in English (local language proficiency preferred).

🌟 Benefits of Working with Takeda

• Opportunity to work with a globally recognized biopharma leader.
• Exposure to international clinical quality standards.
• Collaborative work culture with career growth opportunities.
• Competitive compensation package (₹18–30 LPA).
• Travel exposure (up to 30% domestic travel).

📌 Application Process

Application Link