Manager

• Provides QA support for small molecule drug substance technology transfer and improvement of existing manufacturing processes.
• Contributes to the overall development, implementation, and execution of quality systems in support of the commercial production of JJIM products.
• Ensures proactive and continuous compliance with applicable Health Authority regulations and J&J standards.
• Conducts investigations, performs audits, collects data, analyzes trends, and prepares reports as required.
• Escalates issues as appropriate to Senior Management and supports the Management Reviews.
• Works closely with internal functions, other Quality Assurance functions and external manufacturers.
• Pursues the high standards of quality and compliance.
• Provides leadership and ensures the success of external manufacturer qualification and monitoring.
• Coordinates and executes the EQ Management activities including continuous oversight and management of Quality activities during manufacturing.

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