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
Join bluebird bio’s enthusiastic and collaborative site Quality leadership team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to join our North Carolina manufacturing facility. The Associate Director, Quality Services and Compliance will lead the Quality Services and Compliance department ensuring conformance to established quality processes and standards while actively working to continuously improve them. This role is responsible for the following site quality functions: Quality Compliance, including the internal audit program, health authority inspection management and data integrity program, as well as the document control and training and Quality Validation functions. Additionally, you’ll serve on the site quality leadership team to build the Quality department as bluebird grows; creating an energized, efficient, and effective team. "
HOW YOU’LL FLY
- Responsibilities include oversight, as well as optimization of infrastructure and procedures, for deviations, CAPA, risk management, change control, complaint, APQR, quality metrics, quality council, document management, quality training and inspection readiness
• Provide oversight and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports
• Partner with the corporate Quality Services & Compliance function to further develop and maintain alignment for the Quality programs
• Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and QC instrument qualification and validation activities
• Partner with client groups to develop and provide quality support for product technical transfer plans and the implementation of strategies for characterization and validation studies
• Participate in cross-functional risk assessments and process parameter classification
• Manage and provide quality oversight for the data integrity program at the bRT site
• Ensure compliance with current U.S. and EU cGMP regulations and industry standards
• Manage the inspection readiness program at the site to ensure site is always inspection ready and manage the logistics of any corporate, external or Health authority inspections at the site
• Oversee the document control and training groups, ensure compliance and integration of applicate regulatory expectations
• Manage the internal audit program
• Facilitate the site quality council, providing timely and metric driven updates on the status of quality systems for management reviews and other leadership forums
• Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction
• Provide input for continuous improvement of corporate quality systems
• Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with site goals and corporate training philosophy
• Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
WHAT YOU’LL BRING
• BA/ BS and a minimum of 15 years in Quality Assurance and/or Quality Control, including experience with compliance and health authority inspections. Previous QAV experience and/or support highly desired
• 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.
• 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, communicating and resolving complex issues along with fostering relationship building with site and global functions
• Experience with impact and risk assessment tools, process mapping and process improvement tools
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.