Quality Manager, Quality Assurance

Jobgether; India; On-site; INR 1,800,000 - 2,800,000; Full time

Benefits offered by this job

International team collaboration

Professional growth opportunities

Flexible work-life balance

Inclusive workplace

Job summary

Jobgether is seeking a Quality Manager for Quality Assurance to strengthen QA standards and ensure regulatory compliance across a global clinical research environment. You will lead risk-based audit strategies, oversee internal and vendor audits, and drive continuous quality improvement across GxP areas including EU GVP, US FDA CFRs, and ICH-E6.

You will collaborate with operational teams and external partners to protect patient safety and trial integrity, while supporting QA consulting services

Qualifications

• Detail-oriented quality professional with auditing experience in GCP/GVP environments.
• Experience conducting GCP/GVP audits including TMF and vendor audits.
• Knowledge of ICH-E6, EU GVP and FDA requirements; strong regulatory familiarity.
• Strong communication, facilitation, and collaboration across international teams.

Responsibilities

• Develop and maintain internal Quality Risk Assessment methodology and Audit Universe.
• Lead QA activities related to procurement processes and vendor oversight.
• Ensure ongoing compliance monitoring with applicable laws and industry standards.
• Coordinate and contribute to internal system and vendor audits per the Audit Plan.
• Manage pre- and post-audit activities, documentation, and quality control.
• Support client-contracted QA services including audit planning and execution.
• Provide QA consulting guidance based on regulatory experience.

Skills

Attention to detail

Communication skills

Cross-functional collaboration

Problem solving

Organizational skills

English fluency

Regulatory knowledge

Education

Bachelor's or Master's in biomedical sciences or related

Job description

The Quality Manager, Quality Assurance will play a key role in strengthening quality standards and ensuring regulatory compliance across a global clinical research environment. This position focuses on developing and managing risk-based audit strategies, overseeing internal and vendor audits, and driving continuous quality improvement. You will act as a key ambassador for the Quality Assurance function, collaborating with operational teams and external partners to maintain the highest standards of GxP compliance. Working across complex clinical research and pharmacovigilance activities, you will help identify potential risks and protect the integrity of clinical trials and patient safety. The role also involves supporting quality consulting services and providing expert guidance on regulatory requirements. Join an international, collaborative team committed to advancing innovative treatments and making a meaningful difference for patients worldwide.

Accountabilities

In this role, you will drive quality assurance initiatives, oversee audit programs, and ensure that internal operations and external partnerships meet applicable regulatory standards. Your responsibilities will include:

• Develop and maintain the internal Quality Risk Assessment methodology and a comprehensive Audit Universe.

• Lead Quality Assurance activities related to procurement processes and vendor oversight.

• Establish and manage mechanisms for ongoing compliance monitoring with applicable laws, regulations, and industry standards, including EU GVP, US FDA CFRs, PMDA requirements, and ICH-E6.

• Partner closely with Vendor Management and operational teams to develop and implement risk-based audit strategies.

• Coordinate and contribute to internal system and vendor audits in accordance with the established Audit Plan.

• Manage all pre-audit and post-audit activities, ensuring appropriate documentation, follow-up, and quality control.

• Conduct audits within areas of GxP expertise when required.

• Coordinate audit documentation peer reviews and quality control activities.

• Support client-contracted Quality Assurance services, including audit planning, coordination, and execution.

• Provide GxP Quality Assurance consulting services based on your expertise and professional experience.

• Monitor organizational compliance, identify potential risks at an early stage, and assess their impact on audit strategies, planning, and execution.

• Promote a strong quality culture and act as an ambassador for the Quality Assurance department across the organization.

Requirements

The ideal candidate is a detail-oriented quality professional with hands-on auditing experience and a solid understanding of clinical research and pharmacovigilance regulations. You should bring:

• A Bachelor's or Master's degree in biomedical sciences, natural sciences, health sciences, or another relevant scientific discipline, or an equivalent combination of advanced education and relevant industry experience.

• At least 3 years of direct auditing experience in GCP and/or GVP environments.

• Experience conducting GCP audits, including investigational site, Trial Master File (TMF), and vendor audits, and/or GVP audits involving safety case processing and reporting.

• At least 2 years of experience managing audit programs, including developing and maintaining risk-based audit plans.

• Experience with both GVP and GCP regulatory requirements, or a strong willingness to expand your expertise across both areas.

• Knowledge of relevant regulatory frameworks and quality standards, including ICH-E6, EU GVP, and applicable FDA requirements.

• Strong organizational skills and exceptional attention to detail.

• Excellent communication and facilitation skills, with the ability to collaborate effectively across international teams.

• A proactive, adaptable, and solutions-oriented approach to quality management and regulatory compliance.

• Fluency in English, with the ability to communicate effectively in a global professional environment.

Benefits

• Opportunity to contribute to clinical research programs focused on rare diseases and oncology.

• Meaningful work supporting the development of safe and effective treatments for patients worldwide.

• Collaboration with an international team of specialists across clinical research, pharmacovigilance, and quality consulting.

• A supportive and collaborative working environment that encourages professional growth and knowledge sharing.

• An inclusive workplace where different perspectives and contributions are valued.

• A culture built around quality, integrity, trust, agility, accountability, and collaborative partnerships.

• Opportunities to take ownership of meaningful projects and make a direct impact on quality standards and patient outcomes.

• Emphasis on flexibility and work-life balance.