Sr. Manager R&D Audits and Inspections (12 month contract) in London

Brief Description:

This position primarily provides support to the Clinical and Pharmacovigilance Quality Assurance (CPVQA) function for Pharmacovigilance (PV) Systems in:

• Leading the oversight of the PV audit universe

• Ensuring compliance with global, local and regional PV regulations and Jazz’s policies/procedures

Essential Functions

• Assess the vendor risk management SOP and risk modifiers for PV QA audit universe

• Create new procedures and WIs specific for PV QA audit universe

• Develop a tool to support the calculation of risk associated for PV vendors

• Review and assess all current PV vendor risk assessments in terms of risk categorization with input from PV SMEs and update accordingly

• Work with PSMF owner to update the PSMF to reflect the current PV vendors

• Creation of a new annual audit schedule for PV vendors

• Work with business to develop appropriate corrective action / preventative action against observations from inspections and audits.

• Track all relevant corrective action / preventative action details from inspections and audits to completion.

• Escalates issues of critical noncompliance and/or lack of urgency in remediation to senior leadership.

• Contribute to the development and execution of Global PV/Post-Authorization audit strategy, and implementation within the Quality Management System.

• Coordinate and implement strategic audit plans for pharmacovigilance and post- authorization commitment activities that include service providers, vendors, business partner, and internal audits.

• For pharmacovigilance system audits conducted directly by Jazz personnel or conducted by a vendor on behalf of Jazz (external audits) participate as lead auditor/co-auditor and/or manage the relationship with the vendor

• Evaluate corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement; ensure adequate and timely closure of CAPAs generated from audits.

Required Knowledge, Skills, and Abilities

• 5+ years working knowledge / experience of pharmaceutical experience

• Knowledge and experience with GVP required with, GCP, GLP, GMP and GDP is a plus.

• Advanced inspection experience with FDA, MHRA (or other EU Competent Authorities); experience with emerging markets Regulatory Authority such as PMDA a plus.

• GVP auditing experience preferred.

• Disciplined, detail orientated, and strong time management skills

• Ability to work across geographical boundaries with strong leadership and ability to inspire colleagues.

• Sound judgment and decision-making skills.

• Must be able to influence and motivate others without authority.

• Action and results orientated.

• Project management skills desirable.

Required/Preferred Education and Licenses

• Bachelor’s degree in a related field is required; Master’s degree in management, leadership

• Lead auditor certification desirable.