Associate Director, Quality Control at bluebird bio, Inc. in Cambridge, Massachusetts

Job Description:

Join bluebird bio s enthusiastic and collaborative team and contribute to the overall success of our novel gene therapy approach. This is an exciting hands-on leadership role within our Quality Control team at Sr. Manager or Associate Director level. We seek an experienced Quality Control professional to lead activities associated with QC strategic management of stability programs for ancillary materials, starting materials and drug products in support of our early and late-phase clinical development to ensure successful clinical and commercial regulatory filings in the EU and US. You will provide significant contribution to the daily operations of the Quality Control laboratories as well as strategies for future growth and improvements.
This position requires partnering with various internal laboratory operations as well as a Contract Testing Organizations (CTO) network. The position requires a strong knowledge of cGMP/ICH/FDA/EU regulations.

What you will do all day:

* Lead and build a team to manage Stability across a multi-product portfolio

* Build a risk-based stability program for ancillary materials, starting materials and drug products in support of our early, late-phase clinical, and future commercial development

* Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for ancillary materials, starting materials and clinical drug product

* Utilize statistical software to trend stability data and establish retest and expiration dates

* Oversee cross-functional laboratory investigations related to stability and laboratory operations

* Collaborate with Quality management and CTOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports

* Prepare and review CMC stability sections for clinical regulatory filings, MAA, and BLA

* Manage timelines to meet corporate goals

This is your dream job if you have:

* Bachelor s or Master s degree in a scientific discipline, 10-15 years of related experience in QC GMP environment, and at least 5 years managing direct reports

* Strong knowledge of cGMP/ICH/FDA/EU stability regulations

* Solid understanding of statistical analysis as it relates to product stability trending and establishment of shelf life

* Experience and strong understanding of statistical software packages such as JMP

* Superb communications both written and oral skills and do-what-it-takes attitude

* Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders

* Excellent organizational skills, ability to navigate and be successful in fast-paced and highly-matrixed work environment with changing priorities

* Experience with CTO/CMO management and strong interpersonal skills with the ability to motivate others, influence, and negotiate challenging situations

* Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

b yourself.
bluebird bio is committed to fostering an environment where everyone can be their whole selves and know they are valued. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. As an equal opportunity employer, we do not discriminate on the basis of race, religion, color, national origin, age, gender (including pregnancy, childbirth, or related medical conditions), sex, sexual orientation, gender identity, gender expression, age, disability, veteran status, or other applicable legally protected characteristics.