Manager / Sr Manager, Quality Operations
Join bluebird bio's enthusiastic and collaborative Quality Operations team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to manage and oversee a team focusing on batch review, resolution of quality systems encountered while manufacturing and testing, and generation of disposition documentation. The Senior Manager of Quality Operations will support the organization by ensuring conformance to established quality processes and standards in a virtual environment while actively working to continuously improve them. In this position, you will be responsible for overseeing batch review, manage all activities associated with release testing, resolution of quality systems encountered during manufacturing and release testing, and generation of disposition documentation. Additionally you'll work closely with other Quality Management teams to build the Operations department as bluebird grows; creating an energized, efficient, and effective team.
About the Role:
About the Role:
- Support bluebird bio Manufacturing and Testing Operations during batch production, ensuring unexpected events are handled compliantly and in a timely manner.
- Manage release testing and adherence to scheduled timelines for bluebird bio Starting Materials lots.
- Management of data review, analysis, identification of trends, and complex problem solving.
- Manage problems of diverse scope using a high degree of judgment and risk-based decision making.
- Ensure an appropriate, consistent, and harmonized approach is standard across all CMOs and CTOs.
- Review and approve documents including: Manufacturing batch records in support of product release; Standard Operating Procedures, Process Validation Protocols and Reports, and Quality Agreements.
- Prepare and review documents associated with deviations, investigations, OOS results, and CAPA action plans.
- Ensure all documentation complies with cGMP regulations and industry guidelines.
- Build on relationships with our Quality partners at CMOs and CTOs.
- Budget and contract management with CTOs.
- Track and trend quality system generation at CMOs and CTOs, providing periodic updates to Management - Review and approve deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required.
- Track and trend batch execution at CMOs and release testing at CMOs, providing periodic updates and Quarterly Metrics data to Management, with alignment to target Turnaround Times and Disposition dates, number of comments and deviations per batch.
- Identify quality issues and effectively and proactively resolve them in a diplomatic, professional, and constructive manner.
- Engage in activities to continuously assess and improve Lot Review and Disposition processes.
- Support the development, implementation, and revision of corporate quality systems.
- BA/ BS and a minimum of 10+ years in Quality Assurance is required
- Demonstrated leadership within teams producing results
- Ability to demonstrate project management skills
- Ability to intake and process large quantities of information, to make concise and timely decisions.
- Experience with product lot disposition, investigations, change control, and process qualification and validation
- Ability to communicate above and below level in a way that fosters positive relationship building
- Strong knowledge of GxP regulations, quality systems, and guidance documents
- Experience with managing contract manufacturing and contract testing organizations would be beneficial in this role.
- Demonstrates flexibility and excels within a fast-paced environment with changing priorities.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
- Lean Six Sigma Green Belt - preferable but not required
- Experience with Sharepoint, Veeva eQMs, Visio, and excel based programs a plus
- Ability to travel approximately 15-25%
- Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself