Posted in Other 29 days ago.
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Type: Full Time
Location: Cambridge, Massachusetts
Join bluebird bio s enthusiastic and collaborative Quality Operations team to contribute to the overall success of our novel gene therapy approach. We seek a Lead Specialist position within our Quality Assurance External Manufacturing/Cambridge team to support the nest by ensuring conformance to established quality assurance processes and standards while actively working to continuously improve them. In this position, you will be responsible for building out and supporting the quality assurance oversight of bluebird bio s growing network of external Qualified Treatment Centers (QTC) inclusive of apheresis collection centers and cell therapy labs. As such, you ll provide operational QA oversight for apheresis products intended for manufacturing into bluebird bio drug product and the QTC. You will collaborative internally with Apheresis Operations, Patient Operations, Manufacturing Operations, Clinical Trial Strategy Teams and Quality Compliance, at minimum. Additionally, you ll work within the Quality Operations team to provide support for the disposition of drug product form multiple CMO. Day to day responsibilities include establishing and maintain Quality Agreements with QTC s, QA oversight of documentation related to apheresis intended for drug product manufacturing, resolution of quality system records encountered while collecting apheresis products, and quality oversight of QTC use of bluebird bio traceability systems. Additionally, you ll provide internal quality support for Patient Operations and Apheresis Operations teams.
About the position:
* Ensure quality expectations are met in the areas of Good Tissue Practices (GTP), Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) for apheresis products and bluebird bio QTC
* Work with bluebird bio Apheresis Operations and Patient Operations in providing quality oversight of external partnerships with QTC
* Ensure an appropriate, consistent, and harmonized quality approach is standard across all QTC s through Quality Agreement initiation, review and maintenance
* As required, review and approve documents including apheresis collection records, policies and procedures, deviations, investigations, OOS results, and CAPA action plans
* Ensure all documentation complies with cGTP, GMP and GDP regulations and industry guidelines
* Build relationships with QA partners at QTC, ensuring quality issues are tracked and resolved in a timely manner
* Track and trend quality system generation at QTC s, providing period 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
* Identify quality issues and effectively and proactively resolve them in a diplomatic, flexible, and constructive manner
* Engage in activities to continuously assess and improve processes
* Support the development, implementation, and revision of corporate quality systems
* BA/ BS and a minimum of 7+ years working experience in cell therapy (or applicable) environment
* Knowledge of FACT accreditation requirements and their application for collection of apheresis and/or cell therapy lab
* Experience with quality agreements preferred, not required
* Experience with quality system record resolution including deviations, investigations, change controls
* Demonstrated leadership within cross-functional teams with identifying areas of improvement, then participating in the design and delivery of improvements
* Ability to communicate above and below level in a way that fosters relationship building
* Strong knowledge of GTP regulations and guidance documents
* Proven history of developing and implementing processes within cross-functional working teams
* Ability to thrive in an extremely fast-paced environment with changing priorities while multi-tasking
* Ability to work effectively in a collaborative team environment with both internal and external partners - 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 priorities with aggressive timelines
* Lean Six Sigma Green Belt preferable but not required
* Ability to travel approximately 15%
* Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself.
bluebird bio is committed to fostering an environment where everyone can be their whole selves and know they are valued. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. As an equal opportunity employer, we do not discriminate on the basis of race, religion, color, national origin, age, gender (including pregnancy, childbirth, or related medical conditions), sex, sexual orientation, gender identity, gender expression, age, disability, veteran status, or other applicable legally protected characteristics.