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.
- The Quality System Manager supports the development and implementation of Blueprint’s Quality Management System (QMS). The individual will develop phase appropriate processes to navigate the company through the product lifecycle in adherence to GxP regulation and guidance. In addition, the Quality Systems Manager supports the training and compliance functions and helps to develop the metrics and risk management programs.
- Supports the development of the Blueprint QMS by driving system/process improvements to Deviation, Change Control, Complaints, and CAPA
- Develops training and supplemental material to support effective use of internal systems
- Develops internal procedures and policies in line with Blueprint’s phase of development
- Compiles operational metrics to support Management Review and Quality Council
- Leads the document management function, including document storage, retention, and archive
- Leads and/or supports the internal inspection management program
- Business Process Owner for GxP computerized systems
- Assist in the configuration and validation of electronic systems
- Administers the Document and Training Management system
- Supports the risk management program through risk facilitation and program improvements
- B.S. degree in life sciences, chemistry, engineering or equivalent
- A minimum of 8 years industry experience
- Strong knowledge of GxP regulations, trends, and practices pertaining to pharmaceutical product development, manufacturing, testing, and clinical operations
- Ability to work independently in the development of company systems
- Experience in the development, implementation, and training of various quality systems (e.g. Deviation, CAPA, change control)
- Experience in the configuration, validation, and steady state management of GxP computerized systems
- Experience with management of document control, storage, and archive activities
- Ability to effectively develop and deliver training material for new processes
- Investigational skills, including Root Cause Analysis and Product Impact Assessment
- Experience leading and/or facilitating risk management activities (e.g. FMEA, PHA…etc)
- Familiarity with continuous improvement initiatives; Six Sigma Green belt a plus
- Experience with internal and/or external audits; ASQ CQA a plus
- Ability to apply an innovative mindset to developing risk-based approaches to GxP processes
- Strong interpersonal and communication skills
- At home in a results-driven, highly accountable environment where you can make a clear impact
- A collaborator who can effectively manage inspection activities
- Ability to manage/own multiple projects in a constantly evolving environment
- Ability to Travel (5- 10%)
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.