Sr. QA Auditor - 41779

Plan and conduct independent 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.

Responsibilities

• 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.
• Manage Quality Issues and present educational programs and guidance to operational staff on compliance procedures.
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans; track until closures for quality events arising from Quality Issues, Audits, Inspections, or similar QA activities.
• Provide quality assurance consultancy activities and projects for clients within budget and established timelines.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Host audits/inspections, ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections.
• May perform GLP Archivist duties where needed.
• Manage/oversee quality events updates in eQMS and/or maintain the electronic quality management system (eQMS); provide support in relation to the audit lifecycle.
• Lead, collaborate, or support QA initiatives/projects for quality and process improvements.
• Assist in training of new Quality Assurance staff.

Requirements

• Bachelor's Degree.
• Preferred: 5 years of experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance.
• GXP experience.
• Equivalent combination of education, training, and experience.
• 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.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Pay

The potential base pay range for this role, when annualized, is $75,400.00 - $188,600.00. The actual base pay offered may vary based on job-related qualifications such as knowledge, skills, education, experience, location, and 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.