Quality Assurance Manager supporting small molecule drug substance manufacturing for Johnson & Johnson. Ensuring compliance and quality across external manufacturing processes in the EMEA region.
Responsibilities
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.
Requirements
Minimum Bachelor's Degree in Science/Pharmaceutical/Pharmacy/Chemistry / Technical / Synthesis Process technology / Chemical Engineering Required.
Minimum 6-9 years’ experience in Pharmaceutical cGMP environment is required.
Experience in small molecule drug substance(small molecule API, late intermediate, Registered Starting Material), knowledge of small molecule drug substance synthesis process, quality management/manufacturing is a must.
Experience in External Manufacturing, Technology Transfers, Quality Event Management and Quality System Development is required.
Experience in presenting issues to all levels of the organization is required.
Ability to manage Quality Systems and provide cGMP compliance support to External Manufacturers is required.
Demonstrated experience with small molecule API manufacturing and Quality control is preferred.
Demonstrated experience with quality activities during small molecule API process development, upscaling, validation, and launch is preferred.
Proficiency in computer applications such as the MS Office suite is preferred.
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