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Director, Quality Operations

Director, Quality Operations

Cambridge, MA

 

At Blueprint Medicines, as our name indicates, we are creating a blueprint for the future of healthcare.  We are a leading company in the personalized medicine revolution by focusing on delivering new medicines that are targeted to the genetic driver of disease.  We do this by leveraging our one-of-a-kind drug discovery platform to discover, develop and work to bring highly-selective kinase inhibitors to patients globally.  This prolific scientific platform has enabled Blueprint Medicines to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

 

Responsibilities:

  • Blueprint Medicines is seeking a highly motivated and strong leader to join our expanding Quality organization as a Director of Quality Operations.  Reporting to the Senior Director of Quality Operations, the right candidate will help provide leadership and strategic direction to a team of Quality Operations personnel responsible for GMP activities for products in various stages of development and commercial.
  • Oversee Quality Operations activities for the release of Drug Substance, Drug Product and Finished Goods for projects in all phases of clinical development and commercial
  • Assist in developing and driving process validation strategies based on current industry approaches, experience and decision-making skills
  • Manage the development, review and approval of lifecycle validation master plans, protocols and reports
  • Lead and manage quality with external vendor partners, oversee execution of GMP audit plans, review reports and track corrective actions
  • Manage a team of QA managers and specialists to provide leadership, mentorship and direction
  • Provide direction and ensure timely guidance to Quality Operations personnel during handling and resolution of GMP events (deviations, investigations, change controls and corrective/preventative action assessments)
  • Lead or participate in Quality Risk Assessments
  • Ensure vendor metrics are accurate and presented to vendors, track improvements
  • Contribute to commercial readiness preparations internally and at GMP vendors
  • May act as a subject matter expert for QA oversight of GMP operations during audits and regulatory inspections
  • Participate on interdepartmental program and leadership teams
  • Assist in the development and/or revision of GMP quality processes

Qualifications:

  • Bachelor’s degree in Life Sciences, Chemistry, Engineering or equivalent with at least 10 years of relevant industry experience ideally in all clinical phases through commercialization
  • Complete understanding of regulatory guidance’s and industry practices for product lifecycle
  • Experience with Pre-Approval Inspections
  • Practical knowledge of global cGMPs and ability to make sound judgement and risk-based decisions
  • Strong collaboration, team building and communication skills
  • Experience leading and/or facilitating risk management activities (e.g. FMEA, PHA…etc)
  • Ability and desire to work in a fast-paced environment
  • Must be willing to travel domestically and internationally up to 20%

Competencies:

  • Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands
  • Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
  • Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
  • Relationship Building – Builds productive working relationships across a diverse spectrum of people.
  • Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
  • All applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status

 

All applicants will receive consideration for employment without regard to race, color, religion, sex, age, 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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