Senior Quality Audits Manager
Senior Quality Audits Manager
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Job Description
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 of the internal Tactical Audit Program and will lead and/or coaudit 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 Responsibilities
- Develops 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 ICHE6.
- 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 preaudit and postaudit 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 adhoc activities as requested by Director Quality Assurance and/or VP of Quality
- Mentors 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)
Qualifications :
- A university degree in a healthcare discipline or equivalent scientific area
- Previous experience in a regulated industry in a quality setting preferably in pharmaceuticals or healthcare.
- Thorough understanding of the principles of Quality Assurance
- Experience of participating in audits and inspections
- Excellent communication and facilitation skills within a global organization
- Proactive and selfmotivated
- Knowledge of international regulations related to Pharmacovigilance and Medical Information
Additional Information :
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric environment where people of all cultural backgrounds genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
- Training and career development opportunities internally
- Strong emphasis on personal and professional growth
- Friendly supportive working environment
- Opportunity to work with colleagues based all over the world with English as the company language
Our core values are key to how we operate and if you feel they resonate with you then Ergomed is a great company to join!
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
We look forward to welcoming your application!
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
