Global Compliance Assurance Leader
2 days ago
This is a senior-level position responsible for leading and conducting global quality regulatory compliance audits and assessments of GCP/GPvP.
The ideal candidate will have extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures. They will also have excellent leadership and facilitation skills, as well as the ability to lead audit teams and operate successfully in various team capacities.
Key Responsibilities:
- Support the strategic development of an effective global risk-based audit strategy and program;
- Lead, plan, conduct, document, and follow-up of global quality regulatory compliance audits and assessments of GCP/GPvP;
- Provide technical guidance, leadership, mentoring, and training of other Auditors on audit-related activities;
- Prepare audit reports, according to NVS requirements and timelines;
- Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures;
- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP);
- Identify and communicate quality and regulatory compliance issues to quality management through appropriate channels;
- Lead compliance investigations and initiatives focused on inspection readiness and quality, process, and compliance improvement as requested;
- Support mock pre-approval inspections (PAIs) and HA inspections as needed;
- Mentor GCP/PV staff as required;
- Review and approve audit reports as required and also participate in the Lead Auditor program;
Requirements:
- 15+ years of proven experience in GCP / GPvP / clinical / industry / health authority experience or equivalent;
- 8+ years of GCP/PV auditing experience preferred and willingness to travel up to 60% of the time;
- Ability to lead and objectively evaluate compliance issues;
- Ability to address a variety of tasks within the same timeframe while maintaining oversight;
- Experience with Health Authority inspections and interactions preferred;
- Good quality and compliance leadership and facilitation skills;
- Excellent verbal and written communication, organizational, and interpersonal skills;
- Extensive knowledge of applicable GCP, PV, and GxP regulations, guidelines, policies, and procedures;
- Good knowledge of CSV and 21 CFR Part 11;
- Excellent leadership and facilitation skills, Auditor certification desirable;
Audit Team Performance Metrics Include:
- Audit cycle completion rate and frequency; Audit success metrics, including overall nonconformity rates;](/img/documentation/image2.jpg)
- Time-to-closure for CAPAs and deviations;](/img/documentation/image3.jpg)
- Opportunity discovery and evaluation cycle performance;](/img/documentation/image4.jpg)
- Adherence to standardized audit procedures and reporting templates;](/img/documentation/image5.jpg)
- Industry benchmark comparison data;](/img/documentation/image6.jpg)
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