Clinical Quality Assurance Manager

2 weeks ago


Cambridge, Massachusetts, United States Bicycle Therapeutics Limited Full time
Job Title: Manager, Clinical Quality Assurance

Bicycle Therapeutics Limited is seeking a highly skilled and experienced Manager, Clinical Quality Assurance to join our team. As a key member of our Development Quality group, you will be responsible for ensuring compliance with applicable GLP and GCP standards and global regulations.

Key Responsibilities:
  • Partner with global program teams and supporting functions to advise on GLP and GCP compliance.
  • Assist key stakeholders in building inspection readiness for all stages of the development process.
  • Develop and maintain key quality indicators and introduce measurement of critical to quality factors.
  • Monitor performance against key KPIs both internally and across third parties.
Requirements:
  • Relevant qualification within healthcare or Life Sciences or equivalent professional experience.
  • Demonstrable experience in Quality Assurance within the life sciences industry, ideally covering all clinical phases.
  • Knowledge of GLP/GCLP and GCP global regulatory requirements for clinical trial submissions.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and supportive work environment.

Bicycle Therapeutics Limited is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to building a diverse and inclusive workforce that reflects the communities we serve.



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