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Director, IT Compliance

Cambridge, MA, United States

How will your role help us transform hope into reality?

The Director of IT Compliance plays a critical role in ensuring that the company's information systems comply with regulatory requirements, including GxP, SOX, data privacy, and validation standards. This position combines strategic vision with operational expertise to develop, implement, and manage comprehensive compliance programs. The Director will lead a team of compliance professionals, collaborate with cross-functional departments, and provide guidance to senior management on compliance-related matters. As a Compliance SME, you will be actively involved in various initiatives, including projects, operations, audits, and application changes. The ideal candidate will have extensive experience in the pharmaceutical industry, a deep understanding of regulatory frameworks, and a proven ability to drive compliance initiatives that align with the company's business objectives.

 

What will you do?

  • Develop and implement a comprehensive IT compliance strategy that aligns with the company's business objectives and regulatory requirements
  • Stay current with US/ International regulations, industry standards, and emerging topics pertaining to GxP Computerized Systems, Computer Systems Validation, SOX and Data Integrity. Apply this knowledge to enhance and maintain the Blueprint Medicines systems framework
  • Collaborate with the QA organization to develop and execute scalable, risk-based computerized systems validation (CSV) processes and procedures.
  • Manage the day-to-day operations of the IS compliance team, including resource allocation, projects and changes, vendor management, account management, audit support etc.
  • Represent the IT organization during inspection readiness activities and regulatory agency or partner audits & inspections.
  • Act as IT lead for GxP applications throughout all phases of the system development lifecycle, including concept, design, implementation/validation and operation.
  • Ensure that the company meets its IT compliance obligations, working in partnership with key stakeholders that include Quality, Validation, Legal, Finance, and HR

 

What minimum qualifications do we require?

  • Bachelor’s degree and 10+ years of experience in information systems roles in Life Science Industry
  • 5+ years leading compliance teams with extensive experience in CSV, GxP, SOX and Data Integrity regulations.

 

What additional qualifications will make you a stronger candidate?

  • Ability to seek opportunities to improve existing systems and workflows, balancing innovation with regulatory obligations
  • Strong IT support background with emphasis to regulated systems.
  • In Depth knowledge and understanding of 21CFR Part 11, Annex 11, SOX, Data Integrity, GxP activities, Validation, Change Management and Release Management Processes.
  • Demonstrated leadership qualities, including the ability to influence and inspire cross-functional teams, drive change, and foster a culture of innovation and collaboration.
  • Excellent communication and collaboration skills, with the ability to work effectively across different teams and departments.
  • Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism

 

Why Blueprint?

At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators – the Blue Crew. Through authentic relationships and our collective entrepreneurial spirit and action, we are each empowered to take ownership and execute with strategic prioritization. We put trust in our people to break through norms and conventions using their individual strengths and insights, which drives our success.

This is the place where the extraordinary becomes reality, and you could be part of it.

Patients are waiting. Are you ready to make the leap?

 

Equity, Diversity, Inclusion and Affirmative Action

At Blueprint Medicines, we foster a culture of equity, diversity and inclusion.  A proud Equal Employment Opportunity and Affirmative Action employer, we consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law.  We are also an E-Verify Employer.  We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability in need of an accommodation with the application or recruiting process, please reach out to TotalRewards@blueprintmedicines.com. 

For more information, please see our EEO-AA Policy Statement, the EEO Know Your Rights Poster, as well as our Pay Transparency Statement. 

 

Blueprint Medicines is a global, fully integrated biopharmaceutical company that invents life-changing medicines. We seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/inflammation and oncology/hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing our medicine to patients with systemic mastocytosis (SM) in the U.S. and Europe. Leveraging our established research, development, and commercial capability and infrastructure, we now aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases including SM and chronic urticaria, breast cancer and other solid tumors.

#LI-Hybrid 

#LI-AQ1

 

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At Blueprint Medicines, we foster a culture of equity, diversity and inclusion to empower the Blue Crew to bring their authentic selves to work. A proud Equal Employment Opportunity and Affirmative Action employer, we consider all applicants without regard to any status protected under applicable law and we strive to employ qualified diverse talent. We encourage you to share information about yourself by answering the questions below, to help us comply with federal government reporting and recordkeeping requirements, evolve our ED&I initiatives, and measure the effectiveness of our efforts. Please review the Government Ethnicity and Race Definitions when answering those questions below.

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