Senior Manager, R&D Quality Assurance
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
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 R&D Quality Assurance flocks is all about getting stuff done while working collaboratively with a variety of different functional stakeholders and representatives. Whether it's making sure Quality is part of bbb's everyday ethos, driving inspection readiness activities, or ensuring ongoing compliance with bbb's procedures and regulatory requirements, we are driven by the opportunity to provide continued support and treatments to our patients. Come work with a highly motivated group of birds that loves rising to the challenge as much as we do supporting internal and external customers in an efficient, quality-first manner!
HOW YOU’LL FLY
The Senior Manager, R&D Quality Assurance will support the organization by providing GCP/GVP/GCLP/GLP (GxP) QA oversight for research & development (R&D) activities required at all stages of bluebird bio products’ life cycle. This is an opportunity to help develop the GxP QA function and ensure high quality execution of clinical trials from first in human through commercial marketing authorization.
As a Senior Manager of R&D QA reporting to the Director, you'll help to bring more patients their bluebird days by:
- Managing QA of GxP activities at bluebird, our contract research organizations (CROs), and Investigator Sites to ensure that outsourced third parties (CROs and other GxP service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections and to ensure that the appropriate processes, systems and activities are in place and performed to protect the rights, safety and welfare of our clinical patients.
- Continuously improving GxP quality processes and to support the state of GxP compliance.
- Managing cross functional relationships with internal and external stakeholders and be the Quality Assurance representative to clinical teams.
- Performing R&D QA risk assessments
- Leading and/or supporting R&D QA GxP Inspection readiness efforts and activities during preparation, conduct, and follow-up for Regulatory Agency inspections
- Serving as a R&D QA subject matter expert for controlled documents (i.e. SOPs, WIs, etc.) and R&D QA training and for these topics during audits and inspections
- Monitoring GxP non-conformance trends and communicate this information to management with proposed remediation actions
- Facilitating the tracking of GxP commitments from internal audits, regulatory inspection findings, CAPAs and other regulatory commitments
- Providing project management and compliance management tracking and reporting to ensure timely and successful milestone completion and limit compliance risks
- Supporting GxP compliance and alliance activities with vendors and business partners and lead Quality Agreement creation, management and revision
- Supporting PMSF updates as needed
WHAT YOU’LL BRING
You’re the bird we’re looking for if you have:
- Bachelor’s Degree or equivalent work experience in a scientific or technical discipline
- Five (5) or more years of Quality Assurance experience in a GCP-focused role
- Quality and compliance background, preferably related to GCP/GVP/GCLP/GLP
- Demonstrated analytical and process skills and the ability to apply these skills to bluebird bio’s organization
- Effective communication, consulting, customer service and problem-solving skills
- Excellent time and project management skills
- Strong interpersonal skills and ability to interact with all levels of the organization and cross- culturally
- Ability to build positive relationships with regulators, inter and intra-departmental customers, internal and external stakeholders
- Experience with analyzing and interpreting regulations and laws and ability to apply to current and future bluebird bio’s policies and procedures (may include collaboration with other cross functional areas)
- Global mindset required
- Demonstrated ability to influence others
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.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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