Manager External Quality - Bangalore

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Bangalore, Karnataka, India

Job Description:

Manager External Quality - Bangalore

Johnson & Johnson Innovative Medicines is recruiting for a Manager - External Quality, located in Bengaluru, India.

The Manager External Quality is responsible for providing quality oversight and governance for external manufacturers, suppliers, and service providers to ensure compliance with Johnson & Johnson standards and applicable global regulatory requirements.

The individual is accountable for managing quality systems, supplier quality programs, audit management, non-conformance investigations, CAPA effectiveness, change controls, and inspection readiness activities across the external supply network.

This role ensures that externally manufactured products and materials consistently meet quality, safety, efficacy, and regulatory requirements throughout the product lifecycle.

The position requires close collaboration with internal cross-functional teams and external partners to proactively identify, assess, and mitigate quality and compliance risks.

Additionally, the role is responsible for maintaining oversight of supplier qualification and lifecycle management activities, including quality agreements, risk assessments, performance monitoring, audit programs, regulatory inspections, compliance governance, and continuous improvement initiatives.

The Manager - External Quality supports the implementation of robust quality systems and ensures external partners remain inspection-ready and aligned with global quality and regulatory expectations.

Responsibilities:


* Oversee manufacturing and packaging operations at external manufacturing sites to ensure compliance with current Good Manufacturing Practices and applicable regulatory expectations.


* Confirm that any testing performed at external manufacturing site laboratories complies with Good Laboratory Practices, approved procedures, and applicable quality requirements.


* Ensure that adequate and effective quality management systems are established, maintained, and followed ...