Lead Specialist, Quality Operations (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

Join bluebird bio’s enthusiastic and collaborative Quality Operations team to contribute to the overall success of our novel gene therapies.  In this role, you will play a critical role in ensuring compliance requirements are met for bluebird bio commercial manufacturing by focusing on deliverables supporting batch disposition requirements. Responsibilities include QA review/approval of gene therapy drug product manufacturing records and directly perform disposition activities, including resolution of quality systems and escalations encountered while manufacturing and testing bluebird bio products. You will interface with key bluebird bio systems in ensuring batch documentation and escalations are appropriately tracked. By liaising with internal and external teams at bluebird bio CMO’s, you will ensure alignment with the bluebird bio CMO on release of drug product. The successful individual will support activities ensuring the compliant and timely provision of bluebird bio commercial products.

HOW YOU’LL FLY

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

• Provide QA expertise in support of commercial manufacturing and batch disposition activities.
• Provide QA approval of deviations and investigations related to batch manufacturing (and testing).
• Provide Quality representation on internal bluebird and external CMO cross functional teams for batch disposition activities, deviation.
• Capture and provide key performance indicator data that is compiled to ensure progress and risk visibility to leadership.
• Multitask and prioritize independently in a high paced environment, ensuring compliant use of bluebird bio systems (inventory, traceability) to achieve disposition.
• In-depth knowledge and understanding of FDA expectations, specifically as they relate to batch disposition and product review.
• Exercise considerable latitude in determining objectives and approaches to critical assignments.

WHAT YOU’LL BRING

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

• Bachelors’ and/or Masters’ degree in Scientific field required.
• A minimum of five (5) years of experience in the industry with clinical drug product (Phase II, III) required; commercial experience a plus.
• Broad in-depth knowledge of GxP requirements and risk-based solutions and deliverables (i.e., root cause analysis, investigation approaches, quality system deliverables)
• Experience managing disposition activities.
• Knowledge of aseptic processing and manufacturing.
• Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.
• Self-motivation and organizational skills to manage a workload independently, offering appropriate communication and escalation so solutions and support can be easily identified.

Contract Length: 12 months

Location: U.S. Remote; preference for candidates based in Northern New Jersey. 

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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