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.
Excellent opportunity to join a high-growth biopharmaceutical company in Cambridge. The Director/Senior Director, GCP QA will be responsible for strategic and operational management of the GCP QA activities. Reporting to VP of Quality, this individual will have primary responsibility for QA oversight of GCP activities at Blueprint Medicines, its contract research organizations (CROs) and Investigator Sites to ensure that outsourced third parties (CROS and other GCP/PV service providers) are compliant and prepared for potential Sponsor and Regulatory Inspections and to ensure that the appropriate processes, systems and activities are in place and performed to protect the rights, safety and welfare of our clinical patients. This individual will also oversee, assess and directly work to continuously improve GCP quality processes and to support the state of GCP compliance at Blueprint Medicines. This is an opportunity to develop the GCP QA function and ensure high quality execution of clinical trials from first in human through commercial marketing authorization. This person will manage cross functional relationships with internal and external stakeholders and be the Quality Assurance representative to clinical teams. This individual will be hands on with internal and external partners.
- Lead development, implementation, and maintenance of GCP Quality Systems and SOPs
- Train and mentor staff on global GCP regulations and guidances
- Assure through audits that non-clinical CROs, clinical CROs, clinical sites and supporting services are operating in compliance with the Company’s quality program, regulations/guidelines and SOPs and are acceptable for performing clinical studies and related services
- Provide QA oversight and auditing of eTMFs
- Lead and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions
- Lead preparations for Clinical Operations (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 Ready -Room activities.
- In partnership with the Clinical Operations, Regulatory, and Pharmacovigilance teams, design and implement a risk-based clinical Quality Assurance management system
- Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
- Establish metrics and report the state of GCP Quality and compliance of clinical trials to senior management
- Ensure Clinical Operations activities are compliant with cGCP, cGLP, FDA, ICH, EMA regulations and guidelines and industry standards
- Review key safety, clinical and regulatory documents, such as DSUR, IB, IND and NDA
- Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study and
- Keep abreast of industry developments – forthcoming regulations, guidance, best practices, etc.
- A Bachelor's Degree (or higher) in Nursing, or an MS (or PhD) in a clinical/medical science, is strongly preferred. Relevant professional certifications are a plus.
- 10-15+ years of relevant industry experience in Sponsor companies, CROs, or GCP consulting
- Direct experience in managing Health Authority GCP Inspections; leading/hosting BIMO inspections is preferred
- Has lead document review (Source data verification) initiatives for example: DSUR, IB, NDA, CSR, etc., deploying both internal and external resources, in a compressed timeline to meet corporate objectives.
- 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 and seek 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
- Demonstrated effective time management skills
- Strong professionalism and interpersonal skills
- Sound judgment and commitment to ethical conduct
- Must be willing to travel domestically and internationally up to 25%
- Adaptability/Flexibility – The ability to adapt to working effectively within a variety of situations; adapts enthusiastically to organizational change and to changes in job demands.
- Communication and Teamwork – Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.
- Effective Planning – Embedding discipline and thoroughness in our approaches.
- Perseverance – Pursues tasks with energy, drive and initiative, even in the face of adversity; comfortable in a results-driven, highly accountable environment where you can make an impact.
- Problem Solving – Ability to understand a situation or problem by breaking it down into smaller pieces using a systematic approach and to identify patterns and connections between situations that are not obviously related.
- Relationship Building – Builds productive working relationships across a diverse spectrum of people.
- Organizational Skills – Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.
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.