A cutting-edge pharma organization is looking to make a new hire of a Manager of Quality Engineering: Process Lifecycle. With a drive to develop and deliver a large variety of lifesaving therapeutics to treat disorders, this global biotechnology leader is looking to expand its team.
Job Responsibilities:
- They will support QA oversight of quality standards and systems
- Be Responsible for all transfers to commercial, internal & external
- Conduct Quality Assurance Oversight activities including issue and Risk Management
- Collaborate with internal partners
- Support regulatory document submissions and pre-approval inspections for capital projects.
- Collaborate with peers in Engineering across manufacturing sites with internal partners for the execution of all technology transfers and associated validations
- Carries out Quality decisions regarding technical transfers and, validation activities
- Ensures quality is represented appropriately for regulatory document submissions
Qualifications:
- * 5+ years' GMP experience in pharmaceutical/biotech/or other regulated industry
- * Experience within a global matrix organization
- * Knowledge of current Good Manufacturing Practices (cGMP) principles
- * Knowledge of appropriate regulatory requirements
