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QA Manager (Senior GCP Auditor) - US Remote based



The Quality Assurance Manager Oversees designated global GCP audit programs for compliance to the master audit plan (procedures, execution, QC, compliance to process, etc.). Identifies the scope and leads global audits and associated audit team and facilitates prioritization of global projects for risk-based audits. Ensures the consistent implementation, use and review of SOPs.

What to Expect



  • Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions



  • Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies



  • Analyse and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes



  • Lead and effectively manage constructive crucial interactions with clients or regulatory agencies



  • Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes



  • Interpret applicable quality regulations/standards and create appropriate policies and procedures



  • Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed



  • Mentor/train less experienced auditors



  • Perform other duties, as assigned by management



  • Travel 30-40% Regional (Americas)



  • 100% home-based-Remote Role



Education/Qualifications



  • A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience



  • Experience may be substituted for education.


Experience



  • 8 years in regulatory environment (experience in GCP roles)



  • Experience & regulatory expertise of industry quality systems/standards



  • Ability to interpret applicable regulations/standards



  • Experience in leading process improvement initiatives



  • Ability to communicate and negotiate internal stakeholders effectively



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