Associate Director, Internal Quality Operations
At 2seventy, it's all about time – how you use your time to do meaningful work that matters, who you choose to spend your time with, and how we can give more time to our patients. When you join us, you are so much more than a number – we invite you to bring all of you and become part of a community where we believe we are better 2gether. Are you ready to re-think the (im)possible? Not only are we ready – we are doing it. The time is NOW.
How you'll make an impact:
This leadership role is the best of both worlds: 1) managing (and sometimes hands on help!) a talented group in our GMP Quality Control testing lab. 2) providing strategic vision to the Internal Quality Ops group.
About the team:
The internal QA Operations Team oversees resolution of quality issues encountered with in-process and lot release testing, and stability testing performed both in our internal GMP QC Testing Laboratory, and at our CTO's, as well as supports the Stability, QSAT and Critical Reagents teams with protocol and report generation. There will be external vendor relationship and communication needed to support efficient and compliant processes and program management. Additionally, provide Quality Assurance support for the Analytical Development (AD) laboratory, overseeing resolution of quality issues encountered with lot release and stability testing of early phase programs.
How you'll spend your time:
- Provide oversight and leadership for the Internal Operations QA team
- Support 2seventy bio GMP Testing Laboratory (GTL) Cambridge operations
- Support Analytical Development testing operations related to early phase lot release and stability testing
- Management of data review, analysis, identification of trends, and complex problem solving.
- Review and approve documents including testing, method validation, stability and qualification protocols and reports, lab investigations, retest plans, deviations, expiration extensions and supporting trend analyses, and change controls.
- May be called on to assist in manufacturing batch record review and review of internal documentation and forms in support of product lot release.
- Prepare and review documentation associated with deviations, investigations, OOS results, and CAPA action plans.
- Ensure all documentation complies with cGMP regulations and industry guidelines.
- Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner.
- Engage in activities to continuously assess and improve Quality processes.
- Support the development, implementation, and revision of corporate quality systems.
Who you are and what you've accomplished:
- BA/ BS and a minimum of 10 years in Quality Assurance and/or Quality Control, including experience with quality control laboratory oversight. Previous QC Lab experience and/or support highly desired
- Proven leadership ability with experience managing a team through change and ambiguity
- Experience and/or knowledge of cellular therapy collection, processing, and upstream manufacturing beneficial, but not required
- Experience and/or knowledge of QC biopharmaceutical testing, cell-based assays, stability program management are all pluses.
- Experience with deviation investigations, OOS lab investigations, change control, CAPA development and process improvements
- Strong knowledge of GxP regulations, quality systems, and guidance documents (including ICH)
- Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities and multiple stakeholders
- Experience interacting with external vendors, contract testing organizations, including identifying, communicating, and resolving complex issues
- Experience with impact and risk assessment tools, process mapping and process improvement tools
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view