Senior Manager, External Manufacturing QA at Bluebird Bio Inc. in Cambridge, Massachusetts

Posted in Other 12 days ago.





Job Description:

On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business ("Oncology Newco") as a new entity, with the completed transition expected by the end of 2021.


ABOUT THE NEST


At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We're 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.

ABOUT THE FLOCK


The Senior Manager, External Manufacturing Quality Assurance role is responsible for Quality oversight in manufacturing of our autologous Drug Product by third party Contract Manufacturing Organizations (CMO). This role supports the nest by having responsibility for the maintenance and oversight of GMP activities related to clinical and commercial manufacturing of bluebird bio gene therapy products. This role ensures collaboration and alignment with both internal and external partners to ensure compliant operations and strong relationships exist to ensure the Quality objectives of bluebird bio are being met. Primary responsibility is assuring CMO's compliance to GMP's pertaining to quality agreements, product manufacture, batch records, disposition and resolution of quality systems encountered while manufacturing and testing, including bluebird bio disposition documentation. This role may also have responsibility for leading lead a team of Quality professionals who also support in executing the bluebird bio Quality strategy and objectives.


HOW YOU'LL FLY


As Quality Assurance bird, you'll help to bring more patients their bluebird days by:



  • Support bluebird bio Manufacturing Operations and Quality Control during batch production, ensuring unexpected events are handled compliantly and in a timely manner.

  • Review and approval of batch documentation and batch dossier submitted by the CMO

  • Review of deviations for manufacturing or testing areas and providing quality approval

  • Assuring operations and products meet all requirements for product specifications for appropriate geographical release

  • Establishment and maintenance of Quality Agreements.

  • Manage adherence to scheduled timelines for bluebird bio drug product release/disposition.

  • Prepare key performance indicator data via review, analysis and identification of trends of quality system records at CMOs and provide updates to Quality Leadership as part of Quality Management Review

  • Review documents associated with deviations, investigations, OOS results, and CAPA action plans.

  • Review and approve internal and external documentation, ensuring compliance with applicable cGMP regulations and industry guidelines.

  • Review and approve deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check, as required.

  • Identify 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.



WHAT YOU'LL BRING


You're the bird we're looking for if you:



  • BA/ BS and a minimum of 10+ years in Quality Assurance

  • Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence

  • Experience with managing contract manufacturing and/or testing organizations, including quality agreement negotiation and the building of sustainable, compliant and collaborative relationships with Quality partners at CMOs

  • Demonstrated proficiency in multiple quality systems, including deviations, investigations, CAPA management, change control, document control, product disposition, supplier quality, etc. with strong decision-making skills used risk-based management approach. Experience with process qualification and validation a plus.

  • Ability to intake and process large quantities of information and subsequently make concise and timely decisions.

  • Ability to communicate above and below level in a way that fosters positive relationship building

  • Strong knowledge of cGMP regulations (EU, US) required

  • Strong knowledge of manufacturing processes, lab operations and/or critical systems to support each required

  • Experience in present area of responsibility during regulatory inspections (as applicable)

  • Demonstrated experience in problem solving using continuous improvement approaches (certification by ASQ, Lean/Six Sigma certification or equivalent)

  • Able to manage direct reports, including deep investment in development plan, performance review performance

  • Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines

  • Expertise in use of electronic QMS and all Microsoft applications

All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.


bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.


bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.