Full-Time Senior Quality Audits Manager

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 organization and acts as an ambassador for the PV QA department. 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.

The Senior Quality Audits Manager plays a lead role in representing PV QA in their interaction and exposure to our clients within PV Operations.

Responsibilities:

1. Develops and maintains the internal Quality Risk Assessment methodology.
2. Develops and maintains a comprehensive Audit Universe.
3. Leads Quality Assurance activities in relation to procurement and vendor oversight.
4. Develops, maintains, and manages mechanisms to assure ongoing monitoring and compliance with all applicable laws and regulations (e.g., EU GVP, USFDA CFRs, JMPA, ICH-E6).
5. Conducts internal system and/or vendor audits according to the approved Tactical Audit Plan and Annual Audit Plan, including effective management of pre-audit and post-audit activities.
6. Supports the Audit CAPA team in the effective management of CAPAs arising from vendor audits.
7. Hosts and supports audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities.
8. Undertakes activities related to audits as a service, including conducting audits under supervision, working with clients on a project level, and managing client projects, providing PV QA expertise and knowledge.
9. Conducts audit documentation peer review and quality control activities.
10. Monitors compliance within the organization to ensure early identification and resolution of quality issues.
11. Documents audit findings and recommendations and identifies process improvement initiatives via trending data.
12. Fosters a culture of quality within the organization.
13. Conducts other ad-hoc activities as requested.
14. Mentors, trains, and develops new and more junior PV QA team members.
15. Manages line management tasks (periodic appraisals, holiday approval, ensuring adequate coverage).

Requirements:

• University degree in a healthcare discipline or equivalent scientific area
• Previous experience in a regulated industry (e.g., pharmaceuticals or healthcare)
• Thorough understanding of Quality Assurance principles
• Experience participating in audits and inspections
• Excellent communication and facilitation skills
• Proactive and self-motivated
• Knowledge of international regulations (Pharmacovigilance and Medical Information)

Compensation:

Compensation details are not provided.

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