Manager, R&D QA Development Laboratories at Bluebird Bio Inc. in Cambridge, Massachusetts

Posted in Other 6 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 Quality Assurance flock is all about working together to get the job done! Whether it's supporting the organization by providing GLP/GTP/GCLP QA oversight for research & development (R&D) activities or executing the R&D QA strategy and 21 CFR Part 58 Quality Assurance Unit (QAU) activities we are driven by always providing QA support. Come work with a supportive and driven group of birds that love rising to the challenge much as we do!


HOW YOU'LL FLY


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



  • Leading the GLP/GTP/GCLP R&D QA Strategy implementation, delegated GLP/GTP/GCLP Inspection Readiness efforts, providing Quality Assurance Unit support as described in 21 CFR Part 58, providing metrics tracking and reporting

  • Driving R&D QA risk assessments

  • Serving as the QA partner for pre-clinical activities

  • Helping to lead R&D QA risk assessments


  • Working, building, and fostering cross-functional partnerships throughout the organization

  • Successfully providing procedural development and other process improvements. Where there is cross-reference and/or cross functionality with other bluebird bio functional controlled procedures, ensure harmonization for alignment and compliance

  • Owning in process-audits/phase audits and, facilitate and oversee external audits, deviations and CAPAs

  • Monitoring GLP/GTP/GCLP non-conformance trends and communicate this information to management with proposed remediation actions. Leading activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits. Tracking GLP/GTP/GCLP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory commitments

  • Collect, track, and present all required global R&D QA compliance metrics including vendor and business partner oversight metrics

  • Monitoring global GLP/GTP/GCLP regulatory intelligence to determine impact on bluebird bio's R&D quality system and develop strategies to implement changes

  • Providing project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks

  • Leading R&D QA activities during preparation, conduct, and follow-up for Regulatory Agency inspections and internal audits



WHAT YOU'LL BRING


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



  • Have a bachelor's degree or equivalent work experience in a scientific or technical discipline. A minimum of 7 years of experience in the areas of GXP regulations with a minimum of 5 years of experience in a GLP/GTP/GCLP quality and compliance role

  • Are experienced in Quality and compliance background, preferably related to GLP/GTP/GCLP

  • Are familiar with and have experience with QAU responsibilities as described in 21 CFR Part 58 and have experience working with exploratory, Phase 0, pre-clinical testing groups

  • Have excellent time and project management skills and effective communication, consulting, customer service and problem-solving skills

  • Must be detail oriented, capability to meet deadlines. PC skills to include solid working knowledge of Microsoft Office software (Excel, Word & PowerPoint required)

  • Strong interpersonal skills and ability to interact with all levels of the organization and cross-culturally

  • Build positive relationships with regulators, inter and intradepartmental customers, internal and external stakeholders

  • Analyze and interpret regulations and laws and apply to current and future bluebird bio's policies and procedures (may include collaboration with other cross functional areas)

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.