Manager, IT GxP Systems
Requisition Number: IT19-005
At Blueprint Medicines, 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.
As a member of the IT team at Blueprint Medicines, you will partner with the organization and be the key contributor in GxP projects as well as various other IT projects. This role will report the head of IT Infrastructure & Operations. This is an opportunity to provide support and leadership on key strategic business initiatives at a time of high-growth. If you enjoy working in a fast-paced and rapidly growing environment, this could be the opportunity for you!
* Act as IT lead on all aspects of Computerized Systems Validation for a multitude of environments & applications.
* Interface effectively with system business owners, Quality and associated vendors.
* Stay current with US and international regulations, industry standards, and emerging topics pertaining to computer system validation and data integrity.
* Review and author technical documentation (e.g., User Requirement, Functional Requirements, Configuration, Design Specifications & SOP)
* Develop and execute User Acceptance Testing (UAT) and or leverage vendor where appropriate.
* Prepare, review, and approve computer systems life cycle documents
* Participate in business continuity planning with a cross functional team.
* Make recommendations to improve and optimize existing processes
* Delivery of GxP systems throughout all phases of the system development lifecycle, including concept, design, implementation / validation, and operation.
* Collaborate with the QA organization to develop and execute scalable, risk-based computerized systems validation (CSV) processes and procedures.
* Minimum 5 to 10 years of hands on technical experience
* Bachelor's degree in a related field
* Experienced in the life sciences industry and an FDA & EU regulated environment with an understanding of regulatory compliance
* Experience collaborating with multiple departments including Quality, Clinical, Manufacturing, and Regulatory to identify and meet technology needs.
* Experience with on-premises, hosted, and cloud / Software-as-a-Service (SaaS) delivery models.
* Previous experience validating both cloud-based and on-premise, GxP solutions for intended use.
* Familiar with GAMP5, Annex 11, 21CFR Part 11
* Understanding of IT infrastructure components
* Working knowledge of IT security best practices
* Ability to work in a cross functional team environment with excellent interpersonal and communication skills.
All applicants will receive consideration for employment without regard to race, color, religion, age, 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.