On January 11, 2021, we announced our intent to separate our severe genetic disease and oncology businesses into differentiated and independent publicly traded companies. We will retain focus on severe genetic disease (SGD) and will launch our oncology business (“Oncology Newco”) as a new entity, with the completed transition expected by the end of 2021.

 

ABOUT THE NEST

At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.

ABOUT THE FLOCK

 

Join bluebird bio’s enthusiastic and collaborative site Quality leadership team to contribute to the overall success of our novel gene therapy approach. We seek an experienced Quality professional to join our North Carolina manufacturing facility. The Associate Director, Quality Services and Compliance will lead the Quality Services and Compliance department ensuring conformance to established quality processes and standards while actively working to continuously improve them. This role is responsible for the following site quality functions: Quality Compliance, including the internal audit program, health authority inspection management and data integrity program, as well as the document control and training and Quality Validation functions. Additionally, you’ll serve on the site quality leadership team to build the Quality department as bluebird grows; creating an energized, efficient, and effective team. "

HOW YOU’LL FLY

  • Responsibilities include oversight, as well as optimization of infrastructure and procedures, for deviations, CAPA, risk management, change control, complaint, APQR, quality metrics, quality council, document management, quality training and inspection readiness
    • Provide oversight and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports
    • Partner with the corporate Quality Services & Compliance function to further develop and maintain alignment for the Quality programs
    • Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and QC instrument qualification and validation activities
    • Partner with client groups to develop and provide quality support for product technical transfer plans and the implementation of strategies for characterization and validation studies
    • Participate in cross-functional risk assessments and process parameter classification
    • Manage and provide quality oversight for the data integrity program at the bRT site
    • Ensure compliance with current U.S. and EU cGMP regulations and industry standards
    • Manage the inspection readiness program at the site to ensure site is always inspection ready and manage the logistics of any corporate, external or Health authority inspections at the site
    • Oversee the document control and training groups, ensure compliance and integration of applicate regulatory expectations
    • Manage the internal audit program
    • Facilitate the site quality council, providing timely and metric driven updates on the status of quality systems for management reviews and other leadership forums
    • Provide leadership to staff by directing, mentoring, coaching and developing them towards professional growth, enhanced job performance and career satisfaction
    • Provide input for continuous improvement of corporate quality systems
    • Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with site goals and corporate training philosophy
    • Identify quality issues/discrepancies, and effectively and proactively resolve them in a diplomatic, flexible and constructive manner
    • Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

WHAT YOU’LL BRING

• BA/ BS and a minimum of 15 years in Quality Assurance and/or Quality Control, including experience with compliance and health authority inspections.  Previous QAV experience and/or support highly desired
• Experience and/or knowledge of cellular therapy collection, processing, and upstream manufacturing beneficial, but not required
• Experience and/or knowledge of QC biopharmaceutical testing, cell-based assays, stability program management.
• Strong knowledge of GxP regulations, quality systems, and guidance documents (including ICH)
• Excellent organizational and project management skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities and multiple stakeholders
• Experience, communicating and resolving complex issues along with fostering relationship building with site and global functions
• Experience with impact and risk assessment tools, process mapping and process improvement tools

All our birds embrace the principles of the bluebird bio culture:  b colorful, b cooperative, b yourself.

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.

Apply for this Job

* Required

  
  


U.S. Equal Opportunity Employment Information (Completion is voluntary)

Individuals seeking employment at bluebird bio are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements.

Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Form CC-305

OMB Control Number 1250-0005

Expires 05/31/2023

Voluntary Self-Identification of Disability

Why are you being asked to complete this form?

We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years.

Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

Disabilities include, but are not limited to:

  • Autism
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
  • Blind or low vision
  • Cancer
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or hard of hearing
  • Depression or anxiety
  • Diabetes
  • Epilepsy
  • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
  • Intellectual disability
  • Missing limbs or partially missing limbs
  • Nervous system condition for example, migraine headaches, Parkinson’s disease, or Multiple sclerosis (MS)
  • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression

1Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.