GVP Auditor

Job Title: GVP Auditor

100% FULLY REMOTE but would prefer a local candidate 

TRAVEL: Up to 40% travel may be required (domestic and international) to conduct Site, License Partner, Affiliates, Vendor compliance audits

Summary
This role is accountable for planning, conducting and managing internal and external GVP qualification, routine and for cause (directed) audits, primarily based in the US, reporting to the Head, Global Audits & Compliance. Ideal candidates will have a strong PV background combined with expert audit experience.

Will engage in cross collaboration with teams based in Europe, Asia, and Latin America to provide oversight of end-to-end audit activities as per the approved audit program encompassing systems and processes of the client pharmacovigilance business function, its License Partners, Affiliates, and Vendors.
Conducts timely and accurate risk assessments to ensure the coordination and execution of a risk-based GVP audit program.  
Plans, supports, conducts and reports Pharmacovigilance (GVP) and Medical Affairs and REMS program audits and inspections at the regional level and provides support across the global organization and to Affiliates.  
Serves as a member of Global QA (GQA) participating in and leading GVP audits process improvement initiatives.
This position is responsible for facilitating and communicating CAPA status within QA as well as to cross-functional departments and management and ensures that the CAPA metrics and trending are being reported consistently.
Supports corrective action and preventive action (CAPA) management due to findings and observations resulting from audits, health authority inspections, quality events or deviations.  Assess and conduct effectiveness checks of CAPA to prevent recurrence.
Interpret relevant regulations to aid Clinical Safety, Post-Marketing Safety, Medical Affairs, Commercial PV QA and other departments to apply them in a practical way to ensure compliance of programs for Client products to all regulatory requirements for the protection of human subjects and patients.  
Member of Global QA (GQA) ensuring local and global conformance with regulatory requirements, internal GVP compliance standards.  Serve as SME and support inspection preparedness of Clinical Safety and Pharmacovigilance teams for key Health Authority and support verification that compliance commitments are fulfilled on time.
Supports proactive integration of quality through SOP development and process improvement activities.  

Responsibilities
Contribute to setting the annual GVP audit schedule, including resource demand and budget in support of the Audit Program in support of a comprehensive risk-based GVP compliant quality program Plan, schedule, conduct and report internal and external GVP Audits according to an agreed Audit Program to provide assurance that regulatory, documentation and record-keeping requirements are met internally as well as externally at Sponsor Sites, Vendors, Service Providers, Affiliates and License Partners and in support of REMS programs.
Develop and manage aspects of Sponsor Site, License Partner, Affiliates and Vendor audit program and conduct robust risk assessments to assure that all are appropriately qualified.
Ensure that all assigned audits are completed as required by the Audit Program and in compliance with applicable GQA procedures.
Document audit conduct, findings, CAPA, effectiveness checks, track / verify implementation of CAPA commitments, effectiveness checks and evidence of supporting documentation. and archive within the electronic quality management system in a timely manner.
Escalate critical findings from audits and inspection to QA and functional department leadership.
Review and approve audit finding responses; evaluate and approve corrective and preventive action (CAPA) and associated implementation timelines.
Provide oversight to GVP audits conducted by third parties, review and approve associated audit reports and ensure they are entered in the electronic quality management system. Provide high quality audit reports and trends to system and/or process owners.
Manage GVP audit metrics, tracking of audits and inspections CAPA status for reporting in the Quarterly Quality Reports and QA Councils and Quality Review Boards.
Track ongoing / planned audit activities and provide summary reports to QA management.
Support all aspects of GVP regulatory inspections including preparation, conduct, coordinating responses, evaluating supporting documentation, tracking and verification of CAPA commitment implementation, and effectiveness checks, are completed.
Support global Health Authority inspections as SME and during Inspection Preparedness activities
Engage in ongoing communications with DS QA across global locations, QA Outsourcing Providers, and Consultants.
Provide coaching and mentoring to junior level staff members.
Create or review and revise QA SOPs to ensure that they are current, adhere to global laws, regulations, guidance documents and client standards.
 
General Qualifications
Experience working both independently and as part of a global multifunctional team
Ability to write comprehensive audit reports and summary documentation for senior management and functional areas
Proven organizational skills and strong ability to prioritize workload
Detail oriented and commitment to seeing tasks through to completion
Ability to handle high workloads, stressful situations, and deadlines
 
Experience Qualifications
7+ years of professional Quality Assurance experience with a world-class quality organization in the Pharmaceutical/CRO industry, including 3+ years of direct Pharmacovigilance / GVP compliance auditing.
7+ years of first-hand knowledge of drug development
Demonstrated knowledge of PSMF audit-related information
Proficiency with computerized systems used for audit and inspection management (e.g., Trackwise), Documentation management (e.g., Veeva Vault) and safety reporting management (e.g., eTMF, EDC, Argus, ArisG, IVRS) and MS Excel.
 
Preferred Qualifications
Professional or other related function and familiarity with Oncology, specialty medicines and Companion Diagnostic products
Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies)
Experience with trending of GVP findings and CAPAs
International experience is a plus; but at minimum, experience working with diverse cultures and employees
Expertise working within early development through Phase III and Pharmacovigilance studies. preferred
 
Education Qualifications (from an accredited college or university)
Must have a Bachelor's Degree in a scientific, health care or related discipline and/or background in medical health Profession (RN, Medical technologist).
A Master's Degree or other advanced degree applicable to pharmaceutical drug development is highly preferred.
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Last updated on Nov 1, 2023