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Senior Manager, GCP QA

Company: Blueprint Medicines Corporation
Location: Cambridge
Posted on: June 7, 2021

Job Description:

Senior Manager, GCP Quality Assurance

Cambridge, MA

Requisition Number: QA21-903

At Blueprint Medicines, 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-a-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 Medicines to build a pipeline of novel therapies that span three distinct areas of medicine; genomically defined cancers, rare diseases and cancer immunotherapy.

The Senior Manager, GCP QA will be responsible for conducting the GCP QA activities. Reporting to the Senior Director of GCP QA, this individual will have 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 help 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.

Responsibilities:

  • Contribute in the development, implementation, and maintenance of GCP Quality Systems and SOPs
  • Provide consultation in interpretation of regulations/guidelines, as they apply to GCP practice, awareness of regional regulatory requirement, and phase of study
  • In partnership with the Clinical Operations, Drug Safety & Pharmacovigilance, and Regulatory teams, contribute to the design and implementation of a risk-based clinical Quality Assurance management system
  • Identify QA and compliance related issues and implement solutions to ensure timelines are maintained
  • Assist with establishing metrics and reporting the state of GCP Quality and compliance of clinical trials to senior management
  • Support clinical quality oversight activities for multiple programs within Clinical Development
  • Assist with preparations for GCP/GPvP inspection-readiness for corporate Blueprint as well as CROs and investigator sites.
  • Assist with managing GCP/GPvP Inspections of Blueprint Medicines
  • Continue to develop as an SME for areas of responsibility during regulatory inspections and assist in managing inspection Ready-Room activities.
  • Ensure Clinical Development 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 QA oversight and auditing of TMFs
  • Assist and/or oversee consultant mediated audits; develop, recommend, and follow up on corrective actions
  • Plan and conduct complex audits / mock inspections in agreement with QA management
  • 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
  • Manage development of risk-based auditing schedules
  • Oversee the conduct of the GCP vendor procedures
  • Train and mentor staff on global GCP regulations and guidances
  • Keep abreast of industry developments - forthcoming regulations, guidance, best practices, etc.

Qualifications:

  • 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.
  • 6+ years of relevant industry experience in Sponsor companies, CROs, or GCP consulting
  • Experience in supporting Regulatory Authority GCP Inspections; supporting BIMO inspections is preferred
  • Continue to develop experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including applicable GxP auditing.
  • 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 cross-functional 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 average of 25-40%

Competencies:

  • 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 qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Keywords: Blueprint Medicines Corporation, Cambridge , Senior Manager, GCP QA, Other , Cambridge, Massachusetts

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