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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 email@example.com 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 firstname.lastname@example.org to discuss in confidence.
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