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
Reporting to the Head of Quality Operations & Strategy, this role is responsible for Quality oversight in manufacturing of our autologous Drug Product at third party Contract Manufacturing Organizations (CMO). The Director, External Manufacturing Quality Assurance supports the organization by having responsibility for the maintenance and oversight of GMP activities related to clinical manufacturing of drug product. (Note: this is role is not based at the CMO but may have infrequent travel to the CMO, 1-2x per year) The 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 during validation, manufacturing and testing, including bluebird bio disposition documentation. This role also leads a team of Quality professionals who support in this responsibility.
HOW YOU’LL FLY
As a 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.
- Lead a team of direct reports supporting Quality Assurance for the CMO
- Ensure an appropriate, consistent, and harmonized approach in quality expectations for CMOs, including establishment of Quality Agreements.
- Build sustainable, compliant and collaborative relationships with Quality partners at CMOs
- 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 periodic updates to Quality Leadership
- Manage problems of diverse scope using a high degree of judgment and risk-based decision making.
- 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 15+ years in biopharma with at least 8 years in Quality Assurance/ Quality Operations
- 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
- Experience with early phase production and quality standards (clinical Phase 1-3)
- Ability to intake and process large quantities of information and subsequently make concise and timely decisions.
- Solid understanding and experience with product lot disposition, investigations, change control, and process qualification and validation
- Ability to communicate above and below level in a way that fosters positive relationship building
- Strong knowledge of GxP regulations, quality systems, and regulatory guidance documents in US (and EU, preferred)
- Demonstrates flexibility and excels within a fast-paced environment with changing priorities.
- Ability to work effectively in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
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.