Poland, Senior QA Auditor - GCP Audits

IQVIA Inc; Województwo mazowieckie; On-site; PLN 168,000 - 312,000; Full time

Job summary

IQVIA Inc. is seeking an experienced QA Auditor to plan and conduct independent GCP audits across IQVIA contracts, ensuring compliance with regulations, guidelines and SOPs. You will report findings to supervisors and customers, and advise on corrective actions.

The role requires 5+ years in GCP, with at least 3 years in site audit, plus willingness to travel 30-50% in Europe. Italian audit certification is a plus and ongoing QA process improvements are encouraged.

Qualifications

• 5 years of experience in GCP environment with 3 years in QA Site Audit.
• Experience leading Investigator site audits (7-10 per year).
• Willingness to travel 30-50% mainly in Europe.
• Nice to have certification to conduct audits in Italy per Italian decree (2011).
• Knowledge of QA processes and regulatory environments.

Responsibilities

• Plan, schedule, conduct, report and close audit activities across IQVIA contracts to assess compliance with regulations, guidelines, and SOPs.
• Evaluate audit findings and prepare and distribute reports to stakeholders (staff, management, customers).
• Provide interpretation and consultation on regulations, guidelines, and policies.
• Develop corrective action plans with customers and monitors.
• Review investigations, RCA, CAPA and EC plans and track closures for QA issues.
• Maintain the electronic quality management system (eQMS) and support the audit lifecycle.
• Lead/ collaborate on QA initiatives and training of staff.
• May participate in pre-inspection visits and support regulatory-inspection activities.

Skills

GCP audits

Quality Assurance

Clinical trial audits

Travel 30-50%

Regulatory knowledge

Risk analysis

Project management

Communication skills

Training capabilities

Independent work

Tools

MS Word

Excel

Databases

Job description

Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Support management in promotion and assessment of compliance to regulations, guidelines and corporate policies.

Essential Functions

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs and project specific guidelines/instructions
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
• Provide consultation to customers and monitors in interpretation of audit observations and formulation of corrective action plans
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closure for quality events arising from Audits; and from Quality Issues, Inspections or during similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Maintains the electronic quality management system (eQMS) and provides support in relation to the audit lifecycle
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements
• Assist in training of new Quality Assurance staff
• May be required to manage Quality Issues
• May present educational programs and provide guidance to operational staff on compliance procedures
• May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned.

Qualifications

• Travel 30-50% mainly in Europe.
• 5 years of experience in GCP environment of which 3 years in Quality Assurance Site Audit is a must.
• Experienced leading clinical trial Investigator site audits is a must. (At least 7-10 per year)
• It is a nice to have a certification to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
• Knowledge of word-processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is zł168.100,00 - zł312.100,00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.