Senior QA Auditor: Regulatory Compliance & QMS Leadership

Regulatory Jobs; Durham (NC); In loco; USD 75.000 - 189.000; Tempo pieno

Descrizione del lavoro

IQVIA in Durham, NC seeks an experienced QA professional to plan and conduct audits ensuring regulatory compliance across IQVIA contracts. You will prepare reports, interpret regulations, and advise project teams on corrective actions.

The role covers audit lifecycle from planning to closeout, CAPA, RCAs, and QA initiatives, with opportunities to train staff and lead continuous process improvements within established timelines.

Competenze

• Bachelor's degree required.
• 5 years experience in pharmaceutical/technical QA, with 3 years in QA.
• GXP knowledge and regulatory experience.
• Strong problem solving, risk analysis and negotiation skills.
• Excellent organization and communication abilities.

Mansioni

• Plan, schedule, conduct, and report audits across IQVIA contracts.
• Evaluate findings and prepare reports for stakeholders.
• Interpret regulations and advise project teams on compliance.
• Provide QA consultation to customers and monitors.
• Lead/coordinate QA initiatives and process improvements.
• Assist in training new QA staff.

Conoscenze

Audit planning

Regulatory knowledge

Analytical thinking

Communication skills

Team collaboration

Formazione

Bachelor's Degree

Strumenti

eQMS

Microsoft Office

Descrizione del lavoro

IQVIA in Durham, NC seeks an experienced QA professional to plan and conduct audits ensuring regulatory compliance across IQVIA contracts. You will prepare reports, interpret regulations, and advise project teams on corrective actions.

The role covers audit lifecycle from planning to closeout, CAPA, RCAs, and QA initiatives, with opportunities to train staff and lead continuous process improvements within established timelines.