QA Manager

Responsibilities

• Oversee and coordinate assigned QA programs, including audit and inspection programs and quality management systems at regional or global levels.
• Provide guidance, interpretation, and training to development groups regarding regulations, guidelines, corporate standards, and policies.
• Manage the documentation, reporting, and closure of compliance issues and ensure follow-up on major and critical audit findings.
• Evaluate policies and procedures for regulatory compliance and recommend continuous process improvements.
• Author Quality Assurance Standard Operating Procedures (SOPs) as assigned.
• Maintain the Quality Assurance database to reflect audit schedules, assignments, and reporting status.
• Host customer audits, mock regulatory inspections, and actual regulatory facility inspections.

Requirements

• 7 years of Quality Assurance experience in the pharmaceutical, technical, or a related area.
• Extensive knowledge of pharmaceutical research and development (R&D) processes and regulatory environments.
• Strong knowledge of quality assurance processes, procedures, and GxP.
• Proficiency in word-processing, spreadsheet, and database applications.
• Excellent problem-solving, risk analysis, and negotiation skills.
• Strong leadership, organizational, and communication skills with the ability to manage multiple projects independently.

Preferred Qualifications

• Bachelor's Degree in a relevant field.

About the Company

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.