Job Overview:
Reporting to: Senior Director of Quality Assurance
Responsibilities:
- Support Passage Bio External Manufacturing Operations and Quality Control during batch production and testing, including Person-in-Plant support at contract manufacturing and testing facilities (CMOs)
- Oversee quality activities to assess controls, issues identification and escalation, in alignment with production schedules and vendor activities
- Review and approve documents prior to, during and after manufacturing activities, including validation plans, cleaning verifications, testing documentation and manufacturing records in support of product release
- Develop Quality Key Performance Indicators (KPI) and work with CMO leadership team and internal CMC team to meet and exceed KPIs.
- Identify quality issues and effectively and proactively resolve in a constructive manner.
- Develop and implementing continuous improvement strategies and methods to improve manufacturing quality.
- Management of data review, analysis, identification of trends, and complex problem solving.
- Prepare and review quality system documentation associated with deviations, investigations, OOS results, and CAPA action plans during manufacturing processes.
- Maintain knowledge of global regulatory requirements for the gene therapy manufacturing facility.
- Ensure all documentation complies with cGMP regulations and industry guidelines.
- Support the development, implementation, and revision of Passage Bio quality systems.
- Effectively interact with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging and release of gene therapy products as needed.
- Additional duties as assigned.
Requirements:
- BA/ BS and a minimum of 10 years in Quality Assurance, including experience with external manufacturing quality oversight
- Experience and/or knowledge of aseptic processes andgene therapy production, processing and downstream manufacturing preferred
- Ability to demonstrate project management skills
- Experience with disposition, deviation investigations, change control, and process improvements
- Experience overseeing and managing Quality Assurance or Quality Systems department at the plant level.
- Ability to communicate above and below level in a way that fosters relationship building, including external relationships with vendors
- Strong knowledge of GxP regulations, quality systems, and guidance documents
- Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
- Experience interacting with contract manufacturing and contract testing organizations, including identifying, communicating and resolving complex issues
- Travel expected up to 50% for presence during onsite manufacturing activities