Clinical Quality Assurance Manager/Senior Manager

  • Competitive
  • Waltham, United States
  • Permanent

Manager / Sr Manager Clinical Quality Assurance 

Suitable for: Clinical QA Auditor, Clinical Quality Associate, Clinical Quality Specialist, Clinical QA Manager and Senior Manager Clinical QA 

Are you looking to start a role with a world leading and innovative Clinical Biopharma company based in Massachusetts where you can grow your career? If so, get in touch as we are recruiting for a permanent Manager/Senior Manager of Clinical Quality Assurance.

For this role, they are offering a highly competitive salary, hybrid working flexibility, excellent bonus and a comprehensive benefits package.

Please contact Simba Nyakupinda  at +1 (646) 582-3704 or by email at for more information about this exciting opportunity

For this exciting Clinical Quality Assurance Manager role, your main duties include, but are not to be restricted to, the following duties:

  • Provide compliance support, including issue resolution, impact assessment, and inspection readiness

  • Provides input to clinical functions to ensure clinical trial activities are conducted by CROs in compliance with GCP regulations and internal requirements

  • Provide internal audit support related to systems, documents, and functions

  • Prepare quality metrics for presentation to management

  • Work directly with CROs and other external suppliers and collaborators, managing the chain of communication-related to GCP compliance

  • Ownership of all GCP QA responsibilities in the business

  • Assessing and improving current processes

  • Overseeing and managing relations with CROs based in the US

To be successful in this role, your experience will need to include:

  • 5 years + in Clinical Quality Assurance

  • Previous experience managing CROs and clinical suppliers required

  • Experience from a sponsor company (pharma/biotech), CRO or GCP roles

  • Previous experience with Veeva QualityDocs and ComplianceWire


COVID-19 vaccine required to come on-site; Individuals seeking an exemption from this requirement for medical or religious reasons should reach for an accommodation

Interested in finding out more?

The full job description is available post-application, please apply below. This role is being managed by Simba Nyakupinda at Meet, please contact me at +1 (646) 582-3704 or directly by email at to discuss in confidence.

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