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Senior Quality Assurance Manager at SynteractHCR in Remote

As the Senior Quality Assurance Manager, you will prepare for and participate in audits and inspections. You will ensure compliance with applicable regulatory requirements including setting of QA targets. You will write QA SOPs and Work Instructions, and ensure compliance with SOP training and utilization as well as assisting in the creation of study-related quality assurance planning. You will have management responsibility for select personnel. Specific tasks would include: Supervisory responsibilities include providing guidance, direction and training to select personnel on tasks to be performed as well as timekeeping and performance management responsibilities. Defines audit schedule, approve audit plans and ensure audits are completed on time including reporting and follow up to closure. Conduct, manage, and follow up audits. Author the writing and revision of Controlled Documents. Captures QA metrics; assists in analysis and reporting. Oversight of QA Risk Management Plans for clinical studies. Hosts, facilitates and participates in external audits, facilitates and contributes to audit responses. May participate in the development, review and approval of software validation documentation; ensures QA review of executed validation materials. Ensures feedback questionnaires are issued. Analyzes feedback questionnaire data and issue escalation as appropriate. Manages issue escalation and resolution, ensuring CAPAs are created as needed, followed, and closed. Ensures QA documentation files are maintained. Offers support and training to departments involved in clinical research. As required, assists QA Director with budgeting. Serves as back-up to other QA team members across job functions as needed. Monitors changes in GCP and notifies relevant departments of notable changes. Qualifications Bachelor's degree in a related field of study and 8+ years' experience, or equivalent combination of studies and relevant work experience inclusive of substantial quality management oversight and 1-2 years experience effectively managing others. Expansive knowledge of Quality Management Systems. Advantageous: passed training in QA Systems according to ISO9001. ICH-GCP body of knowledge and the conduct of clinical trials. Proficiency in Microsoft Word, Excel, and PowerPoint, Outlook. Effective verbal and writing skills; English + local language, if relevant.Salary Range: $100K -- $150K Minimum QualificationQuality Management

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