Associate Director, Quality Operations

Durham, NC

Description:

Join bluebird bio’s enthusiastic and collaborative Quality team to contribute to the overall success of our novel gene therapy.  As a key member of bluebird’s new North Carolina manufacturing facility, the Associate Director, Quality Operations is a subject matter expert in GMP regulations that will ensure compliance to applicable regulatory standards, industry best-practices and internal procedures.  The ideal candidate will be responsible for providing strong leadership, strategic planning, and GMP consultation critical to ensuring the quality and safety of bluebird’s products.  This role will be responsible for development and oversight of the Quality Operations program at the NC facility aligning with corporate policies and procedures as required.  This position requires strong knowledge of cGMP/ICH/FDA/EU, will help to author sections of relevant regulatory submissions and defend the overall Quality Operations strategy during site inspections.

About the role:

  • Manage team of Q-Ops product managers and specialists to provide QA representation, guidance, leadership, and direction for the NC Manufacturing facility.
  • Assure a state of continuous inspection readiness
  • A member of Quality Leadership Team
  • Oversee the development of departmental budget for Q-Ops, including personnel needs
  • Author and approve Quality sections of relevant regulatory submissions and product quality reviews
  • Provide Quality support to investigations and excursions, change controls, and Deviation / CAPAs
  • Manage and mentor Q-Ops staff, emphasizing the bluebird bio culture, teamwork, planning, follow-up and effective communication
  • Write and review Q-Ops program policies and procedures
  • Reviews and approves GMP documentation such as batch records, protocols and reports
  • Promotes bluebird’s quality mission, vision and strategy
  • Subject matter expert on internal and external GMP audits
  • Responsible for hiring and successfully managing Q-Ops staff
  • Supports adherence to site quality metrics and provides input into site Quality Council
  • Ensures adherence to current FDA regulations, ICH, and applicable foreign regulations

About You:

  • A bachelors’ and / or Masters’ degree in the pertinent life sciences
  • 10 – 15 years’ relevant industry experience, ideally in all clinical phases through commercialization
  • Experience in facility startup through pre-approval inspection
  • Strong knowledge of cGMP/ICH/FDA/EMA regulations
  • Complete understanding of industry practices for product lifecycle
  • Excellent communication skills
  • Demonstrated ability to work in a proactive and collaborative cross-functional manner
  • Prior experience with vector or gene therapy field is a plus
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between stakeholders
  • Excellent organizational skills, ability to navigate and be successful in fast-paced work environment with changing priorities
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate challenging situations
  • Willingness to build, embrace and demonstrate the principles of the bluebird bio culture at the new research triangle manufacturing facility: b colorful, b cooperative, and b yourself
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