Manager, Quality Assurance

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 FLOCKJoin bluebird bio’s enthusiastic and collaborative Quality Assurance (QA) team to contribute to the overall success of our novel gene therapies.

The QA Manager will participate on cross-functional projects related to QC Compliance, analytical method validation, method transfer projects, critical reagents, stability, and laboratory investigations.

Primary responsibilities include QA oversight (in collaboration with internal QC teams) of contract testing for in-process and stability samples, review and approval of stability protocols and reports, QA oversight of lab / OOS investigations, and critical reagent maintenance.

These activities will encompass commercial projects. In this role, you will own, lead, or support multidisciplinary, multi-site, moderate to complex projects.

HOW YOU’LL FLY You'll help to bring more patients their bluebird days by :

• Providing QA expertise in support of analytical methods, laboratory investigations, stability protocols and reports
• Providing support, guidance and QA approval of deliverables including analytical method validation protocols, SOP’s, risk assessments, reports, and lab exception management / deviations to assure compliance with bluebird and industry requirements.
• Providing support, guidance and QA approval of change control, ensuring appropriate impact assessments to assure compliance with bluebird bio and industry requirements.
• Providing Quality representation on internal bbb and external CMO / CLO cross functional teams for development, method transfer, and assay validation projects.
• Providing Quality Assurance support to bluebird bio’s CMC and Tech Transfer teams.
• Multitasking and prioritizing independently in a high paced environment.
• In-depth knowledge and understanding of FDA expectations, specifically as they relate to Tech Transfer and process validation.
• Supporting the development of solutions to problems of varying complexity which require a high degree of ingenuity, creativity, and innovativeness.
• Exercising 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 eight (8) years of experience in the biotechnology / pharmaceutical industry. Prior experience with commercial drug product preferred.
• Broad in-depth knowledge and expertise in product lifecycle, process validation, analytical methods, including in-depth knowledge of GxP requirements and risk-based solutions and deliverables (i.e., FMEA, PHA).
• Experience with managing Contract Testing Laboratories.
• Expertise in support of method transfer and method validation activities.
• Knowledge of aseptic processing and contamination control.
• Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.
• Knowledge of cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements relevant for method validation.
• Leadership skills to lead cross functional teams to ensure project success.
• Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization.

Location : U.S. Remote Compensation & Benefits We offer a total compensation and rewards package that ranks among the best in our industry.

Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role.

The anticipated annualized salary range for this role is $127,000 - $150,000. Your base pay will be determined based on several factors including market data, demonstrated skills, relevant education or training, experience, qualifications, internal equity, and travel requirements.

Our overall package also includes eligibility for stock, incentive bonuses, and benefit programs, a flexible time off program, as well as paid holidays, bluebird days, and a holiday shutdown in December.

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.