Senior GCP QA Auditor & Compliance Lead

IQVIA; Wayne (PA); On-site; USD 75,000 - 189,000; Full time

Job summary

IQVIA is seeking a Quality Assurance Auditor to plan and conduct independent GCP audits across IQVIA contracts, assess compliance with regulations, guidelines, SOPs and project instructions. You will prepare and distribute reports to supervision, operations staff, management and customers.

The role involves evaluating findings, supporting CAPA, RCA, EC plans, and training new QA staff. Travel 30-50% is required; Bachelor’s Degree Pref and 5 years in pharma/related field (3 years in Quality) are

Qualifications

• Bachelor's Degree preferred and 5 years in pharmaceutical/related area, with 3 years in Quality.
• Knowledge of QA processes, regulatory environments, and documentation.
• Strong interpersonal, problem solving, risk analysis and negotiation skills.
• Effective training and teamwork abilities.

Responsibilities

• Plan, schedule, conduct, report and close audits across IQVIA contracts to assess compliance with regulations/guidelines.
• Evaluate findings and prepare reports for operations staff, management, and customers.
• Provide interpretation and consultation on regulations, guidelines, policies, and procedures.
• Lead/participate in CAPA, RCA, and EC plans and track until closure.

Skills

Interpersonal skills

Problem solving

Risk analysis

Negotiation skills

Training capabilities

Organization and teamwork

Education

Bachelor's Degree Pref

Job description

IQVIA is seeking a Quality Assurance Auditor to plan and conduct independent GCP audits across IQVIA contracts, assess compliance with regulations, guidelines, SOPs and project instructions. You will prepare and distribute reports to supervision, operations staff, management and customers.

The role involves evaluating findings, supporting CAPA, RCA, EC plans, and training new QA staff. Travel 30-50% is required; Bachelor’s Degree Pref and 5 years in pharma/related field (3 years in Quality) are