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Clinical Quality Assurance Manager/Senior Manager
116143
Posted:
15th
March 2023
- 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 simba@peoplewithchemistry.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:
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Provide compliance support, including issue resolution, impact assessment, and inspection readiness
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Provides input to clinical functions to ensure clinical trial activities are conducted by CROs in compliance with GCP regulations and internal requirements
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Provide internal audit support related to systems, documents, and functions
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Prepare quality metrics for presentation to management
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Work directly with CROs and other external suppliers and collaborators, managing the chain of communication-related to GCP compliance
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Ownership of all GCP QA responsibilities in the business
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Assessing and improving current processes
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Overseeing and managing relations with CROs based in the US
To be successful in this role, your experience will need to include:
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5 years + in Clinical Quality Assurance
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Previous experience managing CROs and clinical suppliers required
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Experience from a sponsor company (pharma/biotech), CRO or GCP roles
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Previous experience with Veeva QualityDocs and ComplianceWire
MEDICAL REQUIREMENTS
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 simba@peoplewithchemistry.com to discuss in confidence.