We are seeking an experienced and motivated Quality Assurance Manager to join our Quality Assurance team. This role is responsible for maintaining and enhancing the Quality Management System (QMS), ensuring compliance with global regulatory requirements, and driving continuous quality improvement across the organization.

The successful candidate will lead internal and external audit activities, support regulatory inspections, oversee quality systems and documentation, and collaborate with stakeholders across the business to promote a culture of quality and compliance.

Maintain and continuously improve the Quality Management System (QMS).

Provide guidance and consultation to staff on quality and regulatory compliance matters.

Facilitate regulatory inspections and accreditation audits.

Monitor and communicate changes in local and global regulations relating to clinical research and quality activities.

Maintain and manage the Corrective and Preventive Action (CAPA) system and database.

Lead continuous improvement initiatives arising from audit findings, inspections, and quality reviews.

Support quality-related activities, including Computer System Validation (CSV), vendor management, training, and quality reviews.

Collaborate with cross-functional teams and subject matter experts to ensure compliance and quality excellence.

Provide leadership, coaching, and support to Quality Assurance team members.

Perform additional Quality Assurance responsibilities as assigned by the Head of Quality Assurance.

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers' needs.





Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want – developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

Bachelor's degree in a relevant scientific, healthcare, or life sciences discipline.

Master's degree preferred.

Equivalent professional experience will also be considered.

Experience

Minimum of 8 years' experience in the pharmaceutical, biotechnology, CRO, or life sciences industry.

Strong background in Quality Assurance and auditing.

Experience managing internal, vendor, customer, and regulatory audits.

Proven experience supporting regulatory inspections and quality systems.

Previous people management or supervisory experience preferred.

Strong knowledge of Quality Management Systems (QMS) and applicable regulatory requirements.

Excellent written and verbal communication skills in English.

Advanced Microsoft Office and document management skills.

Strong organizational and time management abilities.

Flexible and adaptable, with the ability to work effectively under pressure.

Strong stakeholder management and relationship-building skills.

Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at

Competitive salary

Adaptable working hours

Holidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)

Medical Insurance for self and immediate family

Gratuity

Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)

📌 Quality Assurance Supervisor - Required Immediate Start (Bengaluru)
🏢 Quanticate
📍 Bengaluru