Senior Manager, Quality Compliance (Contract)

Location

Somerville, MA | United States

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

The Quality Assurance flock is all about working collaboratively and efficiently, while serving both internal and external customers here at bluebird. Whether it’s ensuring ongoing adherence to process and procedures, driving inspection readiness, or supporting our teams, we are driven by our commitment to quality and regulatory compliance. Come work with an energetic group of birds that loves rising to the challenge much as we love serving our patients! In this contract Quality Compliance role, you will be responsible for vendor related activities including, but not limited to risk assessments, audits, and vendor management.

HOW YOU’LL FLY

You'll help to bring more patients their bluebird days by: 

• Conducting, reporting, and overseeing vendor audits (e.g., Treatment Centers, CMOs, CTOs, and other GxP vendors).
• Scheduling, executing, reporting and following-up on external Treatment Center and GMP audits.
• Documenting and reviewing audit reports to ensure accuracy and adherence to SOP requirements.
• Ensuring audit observations are communicated, tracked, and remediated in compliance with internal policies as well as with all applicable regulatory requirements.
• Assisting with the development, maintenance, and execution on the annual audit plan.
• Compiling program metrics as required.
• Maintaining the Approved Vendor List.
• Supporting continuous improvements efforts through the monitoring of metrics.
• Participating and supporting regulatory inspections. Assisting with inspection readiness efforts.
• Monitoring industry inspections trends, new/revised regulations, and guidance for impact to operations.
• Supporting the internal audit program.

WHAT YOU’LL BRING

You’re the bird we’re looking for if you have: 

• B.S. Degree in a science or biopharmaceutical related field.
• 10+ years of experience in GMP and QMS.
• Direct experience leading and conducting GMP audits, interacting with global vendors, suppliers, and CMOs.
• Vendor management experience.
• Experience leading and conducting Treatment Center audits is a plus.
• Direct experience with Veeva, Trackwise, LIMS, SAP, CMMS, etc.

Contract Length: 9 months

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.

Job tags

Salary