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Director, Quality Systems and Compliance

Blueprint Medicines is a top-tier, innovative, public biopharmaceutical company focused on discovering, developing and commercializing highly-selective kinase inhibitors for genomically defined diseases.  Originally funded by Third Rock Ventures, the company has built a one-of-kind annotated compound collection which is delivering a pipeline of novel therapies, and a sophisticated genomics platform.

Blueprint is seeking a resourceful and strategic thinker for a role that is responsible for establishing and maintaining quality system standards for GxP compliance.  This is a unique opportunity to help build a Quality Organization which will support both development and commercial products.

Responsibilities:

  • Create, implement and oversee GxP quality policies and quality manual
  • Establish and implement a Quality Council
  • Implement and manage the Blueprint Quality Management System to include:
  • GxP vendor management system
  • Oversight of the electronic document control and training systems
  • Quality Management Reviews
  • Mock recalls and internal audits
  • Collection and reporting of quality metrics
  • Provide or support GxP/SOP training of all functional areas
  • Develop GxP audit schedules, oversee execution of audit plans, track audit reporting and corrective/preventative actions
  • Oversee external vendors responsible for GxP audit activities
  • Lead preparations for and support preapproval and routine regulatory agency inspections
  • Provide guidance, interpretation and information pertaining to current GMP/GCP/GLPs to apply updates to the Quality System
  • Coordinate and supportthe creation of and revisions to Standard Operating Procedures (SOPs)
  • Provide long range planning of Quality System related activities
  • Work closely with Blueprint management and other functions to design a Quality group that will effectively support the company’s first NDA submission, product approval and commercialization

Qualifications:

  • B.S degree in life sciences, chemistry or equivalent with 10 years of experience in Biotech or Pharma and 5+ years’ experience in Quality Systems management roles.
  • Proven ability to develop and implement GxP quality systems
  • Knowledge of how to identify key quality metrics for maintaining compliance and identifying areas of improvement
  • Experience facilitating inspections by regulatory agencies
  • Understanding of domestic and international regulatory requirements
  • Capabilities:
  • Ability to effectively prioritize and manage multiple projects and tasks
  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk based decisions
  • At home in a results-driven, highly accountable environment where you can make a clear impact
  • A team player, who listens effectively and invites response and discussion
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner

All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

WHO WE ARE:

Blueprint Medicines’ mission is to dramatically improve the lives of patients with genomically defined diseases. Our singular focus is to use our deep understanding of the genetic blueprint of cancer and other diseases driven by the abnormal activation of kinases to craft highly selective medicines aimed at eradicating these diseases.

We don’t think in small steps. We think in giant leaps.

We are driven by the pursuit of new ideas, new innovations, and new ways of thinking.

We know that what each and every one of us does matters and that our success depends on our ability to work together. We believe we are at our best as a company when our employees are thriving and foster a culture that provides opportunities to grow and develop professionally, while also having fun.

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