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 ach