The Senior Quality Audits Manager supports the Director, Quality Assurance by leading all aspects of the design, implementation and management of internal and vendor audits and corresponding Quality Risk Management activities. The position is key in fostering a culture of quality within the PrimeVigilance organisation and acts as an ambassador for the PV QA department. Additionally, the Senior Quality Audits Manager plays an active role in the preparation, maintenance, and execution of the internal Tactical Audit Program and will lead and/or co-audit, both internally and as a billable activity on behalf of clients as requested and in agreement with the Director, Quality Assurance, or the Vice President of Quality. The Senior Quality Audits Manager plays a lead role in representing PV QA in their interaction and exposure to our clients within PV Operations.Role and ResponsibilitiesDevelops and maintains the internal Quality Risk Assessment methodology.Develops and maintains a comprehensive Audit Universe.Leads Quality Assurance activities in relation to procurement and vendor oversight.Develops, maintains, and manages mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, USFDA CFRs, JMPA and ICH-E6.Conducts internal system and/or vendor audits initiated by PrimeVigilance, according to the approved Tactical Audit Plan and Annual Audit Plan, including effective management of pre-audit and post-audit activities.Supports the Audit CAPA team in the effective management of CAPAs arising from vendor audits.Hosts and supports audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities as agreed with Director, Quality Assurance and/or VP of Quality.Undertakes activities in relation to audits as a service, such as conducting audits under supervision, working with clients on a project level, project management with clients and provides PV QA expertise and knowledge.Conducts audit documentation peer review and quality control activities.Monitors compliance within the organisation to ensure early identification and resolution of quality issues.Documents audit findings and recommendations and identifies process improvement initiatives via trending data as provided by Quality Management.Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.Conducts other ad-hoc activities as requested by Director, Quality Assurance and/or VP of QualityMentors, trains, and develops new and more junior PV QA team members.Line management tasks (periodic appraisals, performing holiday approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)
