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 team by contributing to the overall success of our novel gene therapy approach. We seek a self-starter and highly motivated experienced quality professional to manage contract testing organizations for Quality Control. This position will be responsible for managing all activities associated with release testing at CTOs and CMOs from sample submission to COA approval. The ideal candidate will have experience within biopharma QC and/or QA.
HOW YOU’LL FLY
As a Quality bird, you'll help to bring more patients their bluebird days by:
- Manage Quality Control related communications within CTOs and CMOs
- Coordinate testing with external laboratories and ensure adherence to release testing and scheduled product
- Build on relationships within our CTOs and CMOs ensuring issues impacting quality control testing are
tracked and resolved in a timely manner.
- Participate and provide updates on QC testing status at internal and external meetings
- Provide data review of test records and generate Certificate of Analysis (COA).
- Ensure all documentation complies with cGMP regulations and industry guidelines.
- Generate and manage CTO/CMO deviations, investigations, CAPA, and change controls.
- Support routine regulatory filings by providing lot related data
- Support process improvement initiatives across the quality department
- Provide periodic updates of QC Key Performance Indicators to management.
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- BS or MS in a scientific discipline, 5+ years of related experience in QC GMP environment in a clinical and/or
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and
cooperation between all stakeholders (internal and external)
- Demonstrated leadership within teams producing results
- Strong track record of interpreting cGMP/ICH/FDA/EU regulations
- Must have excellent attention to detail and the ability to manage competing priorities with aggressive
- Ability to communicate above and below level in a way that fosters positive relationship building
- Superb organizational, analytical, and communications skills and “do-what-it-takes” attitude
- A passion for addressing the critical unmet medical needs of patients
- Self-directed individual who can work with limited direction in a risk-tolerant, fast-paced, innovative
- Willingness to embrace and demonstrate the principles of the bluebird bio culture: b colorful, b cooperative,
and b yourself
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.