Job description
ABOUT THE NEST
The nest is a place where every role has meaning, every team member is respected, and every day is a chance to fly higher. When you join bluebird bio, you're not just landing a new gig, you become part of a flock that's pursuing curative gene therapies to give patients and their families more bluebird days. We are doers, thinkers and collaborators who embrace and live by our values:
- Persist for Purpose
- Be Compassionate
- Stay humble and curious
- Keep it real
- Celebrate (sm)all wins
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
ABOUT THE FLOCK
Join bluebird bio's enthusiastic and collaborative Quality Operations team to contribute to the overall success of our novel gene therapies. The Manager, Quality Operations is responsible for the quality assurance (QA) GMP oversight of bluebird bio products manufactured at third party Contract Manufacturing Organizations (CMO). The Manager will be part of a core Quality Operations team with direct oversight of CMO vendor oversight, APQR, quality agreements, batch manufacture, disposition and resolution of quality systems and escalations encountered while manufacturing and testing bluebird bio products. Lastly, this position liaises with internal and external teams for applicable quality alignment and execution at bluebird bio CMO's in support of a bluebird bio intended commercial product.
HOW YOU'LL FLY
You'll help to bring more patients their bluebird days by:
- Ensuring manufacturing and testing operations are compliant and performed in-line with bluebird bio approved requirements.
- Managing adherence to scheduled timelines for bluebird bio product release/disposition, ensuring compliant QA disposition of batches, including applicable post-release quality event batch oversight.
- Ensuring an appropriate and consistent approach in quality expectations of CMOs, including external quality oversight of deviations, CAPA, Change Control, Out of Specifications (OOS), lab investigations, complaints and recalls.
- Preparing key performance indicator data via review, analysis, and identification of trends of quality system records at CMOs and provide periodic updates to Quality Leadership
- Reviewing and approving internal and external documentation, ensuring compliance with applicable US cGMP regulations and industry standards and guidelines.
- Identifying issues and effectively and proactively resolve them in a diplomatic, professional, and constructive manner.
WHAT YOU'LL BRING
You're the bird we're looking for if you have:
- BA/ BS and a minimum of 5+ years in Commercial Biopharma with experience in quality operations, product lot disposition, investigations, change control, GxP audits, and APQR
- Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence with excellent attention to detail, project and time management skills, and the ability to manage multiple competing priorities with aggressive timelines
- Experience developing KPIs to properly access the health of a process
- Experience with managing contract manufacturing, material vendors and/or testing organizations
- Ability to intake and process large quantities of information and subsequently make concise and timely decisions involving objective analysis and strategic problem solving
- Ability to communicate above and below level in a way that fosters positive relationship building
- Strong knowledge of GxP regulations, quality systems management, risk management and regulatory guidance documents in US (and EU, preferred) including ICH Q7, Q8, Q9 and Q10
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.
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