Director, Research and Clinical Development QA

How will your role help us transform hope into reality?

You will be responsible for operational and some strategic management of the GCP QA activities. Reporting to Head of R&CD QA, you will have primary responsibility for QA oversight of GCP, and support GPvP (PV), GLP, and GCLP activities at Blueprint Medicines, its contract research organizations (CROs), and Investigator Sites to ensure that outsourced third parties are compliant and prepared for potential Sponsor and Regulatory Inspections. You will also ensure that the appropriate processes, systems, and activities are in place and performed to protect the rights, safety, and welfare of our clinical patients.

You will also oversee, assess, and directly work to continuously improve quality processes and to support the state of compliance at Blueprint Medicines. This is an opportunity to mentor and develop the GCP QA function and ensure high quality execution of clinical trials from first in human through commercial marketing authorization as well as support of post-marketing activities. In this opportunity, you will manage cross-functional relationships with internal and external stakeholders and be the Quality Assurance representative to clinical teams. This role is required to be hands-on with internal and external partners.

You will cross-train with other clinical GxP roles and execute those roles and responsibilities as deemed necessary by business needs. This role will also be responsible for representing R&CD QA on applicable governance charters and cross functional decision bodies.

 

What will you do?

• Lead development, implementation, and maintenance of GCP Quality Systems and SOPs
• Train and mentor staff on global regulations and guidance’s related to clinical study conduct, post-market surveillance, etc.
• Identify opportunities to enhance continuous improvement and sustainable compliance for R&CD quality systems, establish key performance indicators (KPIs) for success
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• Support audit of clinical CROs, clinical sites, and supporting services to assure they are operating in compliance with the Blueprint’s quality program, regulations/guidelines, and SOPs and are acceptable for performing clinical studies and related services
• Provide QA oversight and auditing of eTMFs
• Provide GCP QA oversight of due diligence and integration activities.
• Lead preparations for Clinical Development (corporate and third-party) inspection-readiness
• Lead and manage GCP inspections on behalf of Blueprint Medicines
• Serve as an SME for areas of responsibility during regulatory inspections and directly manage inspection front- and back-room activities
• Must be willing to travel domestically and internationally up to 25%
• Perform other responsibilities as assigned

 

What minimum qualifications do we require? 

• A Bachelor degree (or higher level education) OR comparable experience in scientific or relevant field
• A minimum of 8+ years of relevant industry experience in sponsor companies, CROs, or GCP consulting

 

What additional qualifications will make you a stronger candidate?

• Experience leading document review initiatives (source data verification such as DSUR, IB, NDA, CSR, etc.), deploying both internal and external resources, in a compressed timeline to meet corporate objectives
• Direct experience in managing Health Authority GCP Inspections; leading/hosting BIMO inspections is preferred
• Excellent communication, writing, and presentation skills for effectively interfacing with internal and external organizations, collaborators, and customers
• Demonstrated ability to work independently and in a team environment while seeking resources as necessary
• Ability to assess complex issues, break down into components, and propose viable solutions
• Demonstrated ability to lead and organize team meetings
• Ability to foster effective relationships with vendors, investigators, and colleagues
• Excellent knowledge of Global GCP regulations and industry standards
• Proficiency in study monitoring activities
• Knowledge of the infrastructure and operational characteristics of CROs and centralized services
  • Excellent communication, writing and presentation skills for interfacing with internal and external organizations
  • Ability to assess complex issues and break down into viable solutions through risk management
• 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 E-Verify Participation Poster, the Right to Work Poster, and/or 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.

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