Job Description:
This position is responsible for managing Quality Assurance activities at Johnson & Johnson Innovative Medicine, adhering to Good Manufacturing Practice (GMP) requirements. The role includes tasks such as incoming material release, batch release, change control, event management, supplier qualification, annual product review, and validation compliance activities.
The successful candidate will provide support and direction to all departments regarding specific quality system elements to ensure business, quality, and compliance goals are met.
Key responsibilities include:
* Batch Record Review and Material Release to ensure GMP compliance
* Event Management System Administration, including Review and Approval of Events, Deviations, and Customer Complaints
* Batch Record Design and Approval Management
* SAP Quality Management Module Administration
* Site Change Control System Management
* Annual Product Review Compilation
* Support for Validation Activities on Site
* Validation Protocol and Report Approval
* System Qualification and Process Validation Support
* SOPs/Work Instructions/Form Review and Approval
* Regulatory and Customer GMP Inspection Preparation
* New Process or Modified Process Introduction Support
* GMP Audits on-Site and Vendor Facilities
* SITE Supplier Approval Process Administration
Requirements include a Bachelor's Degree in a scientific/technical discipline, 3-5 years of experience in Quality, Validation, or Compliance roles, and knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.