Manager - Quality
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NOTE : NOTICE PERIOD- IMMEDIATE TO 30 DAYS MAXXXXXXXXX
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!
Job ID: 144762029
Skills:
Supplier Quality, Design Reviews, Fmea, 5 Why, Spc, Quality Management, Field Quality, Product Validation, 8D, pareto, Refurbishment Quality, Iso 9001, Lean Manufacturing, Value Analysis, design optimization, Six Sigma
Skills:
nadcap , Testing operations, Process Variation Reduction, Assembly, Iso 9001, Product reliability concepts, Product testing requirements, Statistical Tools, Spc, engineering design, Six Sigma, New product development and launch methodology, APQP, Lean Manufacturing, Problem-solving methods, Gauging, Process auditing techniques, Machining, As9100, Quality registration schemes, RCCA
Skills:
Java, Selenium, Cucumber, TestNG, Gitlab, AWS, Api Testing, Python, Ui Automation, JUnit, Jenkins, Continuous Improvement, Intelligent automation tools, Quality governance, AI-assisted engineering, Data pipelines, Performance validation, Automation strategy, Test architecture design
Skills:
Cleaning Validation, Process Validation, Qualification and Validation of Equipment, Facility Utilities
Skills:
8d problem solving , Statistical Quality Techniques, Root Cause Analysis, Fmea, Manufacturing Quality Assurance, Spc, Control Plan, Capa, Electronics Product Assembly Processes, APQP, Process Audits, Msa, QMS implementation and improvement, Customer Complaint Management
