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Manager – Quality LS

Location: Bangalore

Experience: 10-15 Years

Qualification: B.Tech/M.Tech in Biotechnology OR BSc/MSc in Microbiology/Biotechnology

Department: Quality

Reporting to: Senior Manager – Manufacturing & WCM

Grade: M13/M14

About the Role:

We are looking for an experienced Manager – Quality LS to lead and enhance our Quality Management System (QMS). The ideal candidate will have a strong background in ISO standards (ISO 9001 & ISO 13485:2016), customer audits, and regulatory compliance within the life sciences, biotechnology, or pharmaceutical industry.

Key Responsibilities:

Quality Management System (QMS) Implementation & Oversight

Ensure compliance with ISO 9001 & ISO 13485:2016 standards

Implement document control, change management, and supplier quality management

Conduct supplier audits and ensure robust CAPA (Corrective and Preventive Actions)

Develop and oversee internal audit programs and staff training initiatives

Maintain cleanroom practices, validation plans, and risk management protocols

Customer & Regulatory Compliance

Facilitate and host customer audits, ensuring robust corrective actions

Review and approve Quality Agreements with customers

Manage and maintain ISO certifications and compliance requirements

Ensure prompt resolution of quality issues and regulatory requests

Team & Process Management

Lead and manage a team of quality engineers/inspectors

Plan and oversee calibration of instruments and testing methodologies

Provide training on quality systems, root cause analysis, and regulatory requirements

Required Skills & Expertise:

Functional Skills:

Strong knowledge of ISO 9001 & ISO 13485:2016 standards

Expertise in root cause analysis, CAPA, and quality tools

Experience in measurement & testing methods within life sciences/pharma

Ability to host and facilitate customer audits & regulatory inspections

Knowledge of cleanroom practices, equipment validation, and process monitoring

Behavioral Skills:

Customer & Result Orientation

Strong Problem-Solving & Decision-Making Abilities

Assertive, Self-Motivated, and Proactive Mindset

Excellent Interpersonal & Team Leadership Skills

Why Join Us

Lead quality operations in a life sciences-driven industry

Work in a high-growth, innovation-focused environment

Drive excellence in quality & compliance standards

If you have a passion for quality excellence and regulatory compliance, apply now!

Manager - Quality