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Manager, Quality Operations

Manager, QA 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-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 Medicine to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

 

Job Summary:

We are seeking an exceptional candidate for a Manager of Quality Operations.  Reporting to the Associate Director of Quality Operations, the candidate will have an opportunity to join a rapidly growing Pharmaceutical Sciences organization, manage product quality for multiple products in various phases of development and assist in the development and implementation of quality operations processes and procedures. 

 

Responsibilities:

  • Oversight of the quality activities associated with manufacturing, testing and disposition of clinical materials
  • Represent Quality Operations on CMC and CMO project teams, identify and provide input on quality issues
  • Manage review of product release and stability data, support method transfers and validations.
  • Review and approve API and drug product and packaging batch records (master and executed), perform disposition of clinical products in multiple phases of development
  • Provide quality expertise, advice and/or assistance across the organization as required
  • Provide input and support for the development and improvement of quality operations processes
  • Support review of CMC documents for regulatory filings
  • Lead or support external supplier audits
  • Establish and maintain effective working relationships with key internal and external stakeholders

Qualifications:

  • B.S degree in life sciences, chemistry or equivalent and 5+ years GMP quality experience in a virtual Pharmaceutical/Biotech setting
  • Strong technical/analytical skills to identify and solve problems
  • Experience managing relationships with contract manufacturers and testing labs
  • Experience with small molecule and solid oral dosage forms required
  • Experience in early phase development transitioning to registration and commercial
  • Working knowledge of ICH quality guidance, EU and FDA drug manufacturing regulations
  • Flexibility in handling work flow in a multi-tasking environment
  • Excellent oral and written communication skills for effectively interfacing with all levels of management and departments internal and external to the company

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
  • Domestic and international travel will be required (5-10%)
  • All applicants will receive consideration for employment without regard to race, age, 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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