Assistant Manager promoting compliance with accreditation and regulatory standards in healthcare. Collaborate with leaders and accrediting bodies to ensure organizational adherence to laws.
About the role
- 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.
- Fluent in English.
Benefits
- Health insurance
- Professional development opportunities
Job title
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