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Director GCP Quality Assurance$ Competitive base salary and comprehensive benefits


Ref: CW-43285

Location: Boston MA

Type: Permanent


We have partnered with an exciting, small biotech sponsor company dedicated to the development and commercialization of novel therapeutics to treat patients suffering from rare inherited genetic blood disorders. Sickle cell disease and beta-thalassemia have limited treatment options and are both characterized by severe symptoms and effects and reduced life expectancy. Our client is driven by their patient-centric mission of delivering these therapeutics and enhancing quality of life for this underserved patient population.

The role: 

 

We are seeking an exceptional individual who is a self starter, excited by the opportunity to be part of building a quality culture from the ground up and serving as internal SME for clinical quality. Reporting to the Vice President of Quality Assurance, the the successful candidate for the Director GCP Quality Assurance position will be primarily responsible for the following:

 

  • Develop GCP compliance strategy for internal and external partners
  • Provide GCP Quality guidance for all clinical development programs
  • Develop, implement and maintain relevant quality management system to ensure compliance with applicable national and international regulations and standards
  • Develop and execute the audit strategy for compliance audits in accordance with both US and international guidelines including clinical investigator sites, contract clinical laboratories, CROs and internal operations
  • Manage Quality Assurance reviews of clinical and nonclinical study documents and regulatory submissions
  • Build and manage a small team of employees and external resources to achieve Quality goals and objectives
  • Manage inspection readiness activities and provide support for audits and regulatory authority inspections for internal stakeholders and external service providers

 

The qualifications: 

 

  • Bachelor degree in a life science discipline, higher degree preferred
  • 15+ years experience in positions of increasing responsibility within a biopharma
  • Hands on experience planning, conducting and overseeing GCP audits
  • Experience reviewing and auditing study related documents including nonclinical and clinical study reports, investigator’s brochures, clinical study protocols, trial master files
  • Solid understanding of domestic and international GLP regulations
  • Experience working within a small biotech environment preferred
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members

 

Other:

 

This is a full-time, 40 hour per week permanent leadership position based in an office setting with up to 25% travel requirement to external partner organizations. Due to the current COVID-19 crisis, our client has agreed to complete the interview and onboarding process for this position remotely. The successful candidate will perform the duties of this position remotely until it becomes safe to travel, at which time this position will be a fully office-based position. 

 

Our client is deeply committed to workplace diversity and inclusion and is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

Caroline Webster

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