QMS Specialist/Manager

Job Title: QMS Specialist/Manager
Employment Type: Full-time

About Us: We are a fast-growing IT company providing SaaS solutions for the clinical research industry, helping global clients streamline clinical trials with innovative, compliant, and user-friendly platforms. To strengthen our commitment to quality, compliance, and continuous improvement, we are looking for a QMS professional to support and manage our Quality Management System.

Role Overview: The QMS Specialist/Manager will be responsible for establishing, maintaining, and improving the Quality Management System in alignment with industry regulations (GxP, ISO, GDPR, 21 CFR Part 11, etc.) and customer expectations. This role will collaborate closely with product, development, compliance, and operations teams to ensure that our SaaS solutions and internal processes meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

• Develop, implement, and maintain the company’s Quality Management System (QMS) in line with applicable standards (ISO 9001, ISO 27001, as applicable).
• Ensure compliance with regulatory requirements relevant to clinical research and SaaS solutions (e.g., ICH-GCP, 21 CFR Part 11, GDPR).
• Create, review, and update SOPs, Work Instructions, Policies, and Templates.
• Conduct internal audits, manage external audits, and coordinate client audits.
• Train and guide employees on quality and compliance requirements.
• Manage CAPA, deviations, risk assessments, and change control processes.
• Monitor and report on QMS performance metrics to leadership.

Qualifications & Skills:

• Bachelor’s or Master’s degree in Life Sciences, Quality Management, IT, or related fields.
• 3–7 years of experience in Quality Assurance/Quality Management within IT, SaaS, Life Sciences, or Clinical Research domains.
• Sound understanding of QMS frameworks. and experience with GxP, 21 CFR Part 11, ICH-GCP, GDPR, and other regulatory guidelines.
• Strong knowledge of document control, audit management, CAPA, and risk management.
• Excellent documentation and detail-oriented skills are mandatory for this job profile.
• Familiarity with CSV (Computer System Validation) is highly desirable.

Job Type: Full-time

Pay: Up to ₹50,000.00 per month

Ability to commute/relocate:

• Ahmedabad, Gujarat: Reliably commute or planning to relocate before starting work (Preferred)

Work Location: In person