Job Overview:
Reporting to VP of Quality Assurance
Responsibilities:
- Responsible for the documentation control functions of the quality management system at Passage Bio.
- Implement, manage, maintain, and support quality assurance activities, including plans that contribute to the Passage Bio ability to achieve and maintain regulatory compliance and ensure product quality.
- Maintains electronic and paper-based documentation, as needed.
- Manages procedural system, including, review, implementation and training.
- Contributes to the management of the Change Control System by generating and reviewing Change Control documents.
- Provides QA support to Regulatory Affairs and CMC, in meeting regulatory compliance and corporate business requirements, including, but not limited to: Performing QA review of CMC documentation, including reviewing and approving documented manufacturing, packaging and analytical records.
- Works cross-functionally with internal departments and external resources on Quality related issues and supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
- Recommends QA system changes to enhance overall job performance and QA functions
Requirements:
- Bachelor’s Degree and/or Master’s Degree
- 5+ years of relevant GXP experience in pharma/biotech company
- Well versed in cGMP/GCP/GLP/ICH/FDA/EU regulations and guidelines
- Proficient in using Microsoft applications (MS Word, MS Excel, MS Powerpoint)
- Detail orientation, with strong communication and organizational skills
- Capable of working with minimal supervision
- Demonstrated ability to manage and configure computerized systems
- Travel Requirements: Some travel (<10%) may be required