ABOUT THE FLOCK

Join 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.

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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.