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Senior Manager, Quality Operations

Senior Manager, 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-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 Senior Manager of Quality Operations.  Reporting to the Senior Director of Quality Operations, the candidate will have an opportunity to join a rapidly growing Quality 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 external manufacturing, testing and disposition of clinical materials
  • Review and approve Master Batch Records and associated GMP documentation (i.e. laboratory/manufacturing investigations, deviations, change controls) to support product release for drug substance, drug product, and finished goods
  • Lead Quality focused meetings between CMOs and partners
  • Manage review of product release and stability data, support method transfers and validations
  • Lead and manage quality with external vendor partners, oversee execution of GMP audit plans, review reports and track corrective actions
  • Ensure vendor metrics are accurate and presented to vendors, track improvements
  • Represent Quality Operations on Blueprint CMC and project teams, provide input and direction for issue resolution
  • Provide support for the review of regulatory filings
  • Provide input and support for the development and improvement of GMP processes

Qualifications:

  • Bachelor of Sciences degree in life sciences, chemistry, engineering or equivalent
  • A minimum of 8 years industry experience
  • Strong knowledge of GMP regulations, trends, and practices pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations
  • Investigational skills, including Root Cause Analysis and Product Impact Assessment
  • Experience leading and/or facilitating risk management activities (e.g. FMEA, PHA…etc)
  • Domestic and International travel required up (10-15%)

Capabilities:

  • Possess a flexible approach to problem solving, be an adept negotiator and apply risk based decisions
  • Strong interpersonal and communication skills
  • At home in a results-driven, highly accountable environment where you can make a clear impact
  • A collaborator who communicates in an open, clear, complete, timely and consistent manner
  • Ability to manage/own multiple projects in a constantly evolving environment

 

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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