Associate Director, Quality Systems & Training

Location
Durham, NC, United States
Posted
Jul 26, 2018
Ref
1198557
Required Education
Bachelors Degree
Position Type
Full time
Join our growing Quality group

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 of Quality Systems & Training is responsible for ensuring that Quality Systems programs are developed, implemented and effectively administered consistently, in a manner that maximizes efficiency, complies with industry standards, and achieves desired compliance targets. This role will partner with bluebird's corporate Quality Systems and Training counterpart to lead the development and implementation of quality systems electronic tools, including oversight of validation deliverables. This role will develop and will maintain the bluebird bio Quality System consistent with international regulations. Thoroughly identify quality systems needs of the business, articulate goals for meeting these needs, and identify creative, high impact and sustainable approaches for meeting these goals. Provide leadership and management of the various quality systems programs to ensure that the appropriate activities are developed and implemented in line with strategic objectives.

About the position:
  • Responsibilities include oversight, as well as optimization of infrastructure and procedures, for deviations, CAPA, risk management, change control, quality metrics, document management and quality training
  • Providing timely and metric driven updates on the status of quality systems for management reviews and other leadership forums
  • Manage problems of diverse scope using a high degree of personal judgment, and must be able to effectively represent bluebird bio Quality to local, corporate, and regulatory agencies
  • Support the development, implementation, and revision of corporate quality systems
  • Partner with internal/external groups, and vendors to identify/implement innovative training solutions that help advance the efficiency, productivity, and technical depth of site personnel
  • Ensure that training and continuing education programs are appropriately reviewed, technically sound, and aligned with site goals and corporate training philosophy
  • Manage logistics for corporate and third-party inspection activities
  • 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
  • Foster a quality mind-set within Quality and throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions

Requirements:
  • Bachelors' and/or Masters' degree in scientific discipline. Technical understanding of biopharmaceutical production
  • A minimum of ten (10) years of experience in the industry, ideally early clinical phases through commercial drug product
  • Expertise in US and EU cGMP guidelines, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
  • Skills to lead cross functional teams
  • Strategic experience with senior leadership team level clients, strong decision- making capability
  • Strong leadership and management experience with ability to work in a matrix environment
  • Excellent written and verbal communication skills including the ability to communicate and negotiate across the organization
  • Microsoft Office, including Word, Excel, PowerPoint, Outlook, MS Project.
  • Ability to travel approximately 20%
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself

Success Factors:
  • Ability to motivate and lead.
  • Effective cross-functional partnering.
  • Risk management experience (FMEA, PHA, etc).
  • Project management experience.
  • LEAN/Six-Sigma training.
  • Experience with regulatory inspections and audits.
  • Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision.
  • Ability to make independent sound decisions and independently manage priorities in alignment with department and site drivers.