Associate Director QA Pv

**Job Brief**:
Associate Director QA PV

**Position Summary**:
The Associate Director, Pharmacovigilance Quality Assurance is responsible for oversight, conduct and coordination of Good Pharmacovigilance Practice (GVP) related audits and inspections and supporting the Amicus Global Drug Safety (GDS) department with QA activities. This includes development of PV audit risk assessments, strategy and plans, planning and conducting audits, issuing audit reports, confirming suitability of corrective actions, preventive action plans (CAPAs), verifying and tracking CAPAs to completion and keeping management informed of associated metrics. In addition, this role leads preparation for PV regulatory inspections.

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**Roles and Responsibilities**:
1.

Lead and/or manage internal/external GVP audits and audit program
- Authors (or oversees production of) audit reports, assessing impact of individual findings and escalation of findings in line with Amicus procedures and policies.
- For outsourced GVP audits, support the external lead auditor in preparation and coordination of the audit, and completion of the audit report.
- Conducting non-routine audits including supporting GVP Due Diligence and ‘for cause’ audits.
- Evaluates the appropriateness of proposed CAPAs and tracks overall CAPA plan to completion. Where required, provides guidance on root cause analysis for CAPAs.
- Development of risk-based GVP audit schedule that will effectively monitor Amicus’ compliance with policies/procedures and applicable laws and regulations. Ensures appropriate input and consultation with Amicus GVP SME’s and QPPV.
- Conducts PV audit Effectiveness Checks (EC) verification in the Amicus quality electronic system.
- Prepares and provides senior management and quality/ GVP oversight committees with metrics and compliance for GVP audits.
- Manage and/or participate in other GXP audits, including, but not limited to, internal process audits, internal mock inspection, external vendor audits and clinical site audits, determine compliance status and identify compliance risks. Also participate in calculating audit and GXP metrics as needed for escalation meetings.
- Facilitates ongoing quality improvement measures through communications of audit results and compliance guidance/training.

2.

Support Pre-and Post-Market Regulatory Inspections
- Prepares the Company and vendors for GVP regulatory inspections.
- Coordinates and oversees inspections readiness program for GVP.
- Participates on inspection teams and hosts inspection as necessary.
- Facilitates development of responses to inspection findings related to GVP, coordinates and oversees implementation of related CAPA plans.
- Conducts or oversees GVP Inspection CAPA Plan verification audits and creation of verification binders.

3.

People Management
- Oversee staff in roles related to GVP QA auditing.
- Mentors and guides staff in the GVP QA auditing roles.
- Provides input into HR reviews as required.

4.

General QA Duties (including but not limited to)
- Author, review and approve relevant QA related policies, and documents.
- Lead or support as needed the QA team with regards to SOP and regulatory training needs.
- Support Amicus GDS with quality assurance training, where required (e.g. different root cause analysis methodologies, writing effective CAPAs, vendor qualification, overview of Amicus quality management system).
- Coordinate QA meetings - including but not limited to creating agendas, management invitations, collation of slides and generation and distribution of meeting minutes.
- Review and approval of internal and vendor PV deviations, CAPAs and ECs.
- Coordinates PV vendor qualification incl. conducting any pre-qualification audits and preparation of audit report. Oversees any PV vendor qualification remediation.
- Review and approval of vendor quality management plan(s).
- Support clinical vendor qualification needs as requested.
- Represent QA at Company meetings, as needed, and provide consultation and advice to the core business on quality and compliance processes; and provide strategic input during the development of such processes/procedures.
- Contributes to Quality Assurance sections of the Pharmacovigilance System Master File (PSMF), as requested.

**Requirements**:
***Educational Requirements**
- Minimum of BA/BSc. degree

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**Professional Work Experience Requirements**
- Approximately five (5) years’ experience, or equivalent, in the pharmaceutical/CRO industries within Quality Assurance function, or regulatory authority inspectorate experience desirable.
- Must have experience leading PV audits/inspections at a global level. GCP and CFR Part 11 auditing experience desirable but not essential.
- Experienced in audit report preparation and managing CAPA plans.

**Experience and Skills**
- Experience with vendor qualification is a plus.
- Experienced in quality metrics creation, reporting and analysis as well as process improvement techniques