Clinical Quality Assurance Manager/Senior Manager

  • Competitive
  • Waltham, United States
  • Permanent
Manager / Sr Manager Clinical Quality Assurance – Competitive Salary + Benefits + Home base flexibility
Suitable for: Clinical QA Manager, Senior Manager Clinical QA, Associate Manager Clinical QA, Manager GCP QA, Sr Manager GCP QA
Are you looking for the next step in your Clinical Quality Assurance career in a fast-paced environment? If so come and join us to help the development of the life sciences industry, developing innovative ways to treat patients.
We are offering a permanent position as a Clinical Quality Assurance Manager/Sr Manager in a meaningful environment, with a competitive salary package, including other benefits.
Please contact Hugo Poitel at +1 (646) 582-3683 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 Hugo Poitel at Meet, please contact me at +1 (646) 582-3683 or directly by email at to confidentially discuss it.
Hugo Poitel Resourcer

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