Global QA Programs Director

IQVIA; Indianapolis (IN); On-site; USD 88,600 - 246,600; Full time

Job summary

IQVIA is seeking an experienced QA leader in Indianapolis to oversee audit programs, ensure regulatory compliance, and drive quality improvements across regional and global QA activities. You will mentor teams, author SOPs, host customer audits, and coordinate with development groups to interpret regulations and corporate standards.

The role emphasizes strong leadership, risk analysis, and cross-functional collaboration.

Qualifications

• Bachelor's degree preferred.
• 10+ years of QA experience in pharmaceutical, technical, or related areas including GXP QA.
• Knowledge of word-processing, spreadsheets, and databases.
• Strong knowledge of pharmaceutical R&D processes and regulatory environments.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and leadership skills.
• Experience conducting audits, writing audit reports and analyzing audits.
• Ability to manage multiple responsibilities and timelines.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to establish and maintain effective working relationships.

Responsibilities

• Plan, schedule, conduct, report and close audit activities as assigned.
• Provide QA support, guidance and management of quality issues as assigned.
• Assist in enhancing QA policies and risk mitigation with regional/global QA management.
• Serve as author for QA SOPs and regional QA representative to the global QA SOP taskforce.
• Provide guidance and training for interpretation of regulations, guidelines and policies.
• Host customer audits and review corrective action plans, as assigned.
• Recommend systems for audits and coordinate scheduling, execution and closure of internal audits.
• Serve as QA contact for assigned internal/external customers and IQVIA areas.
• Oversee documentation, reporting, and closure of compliance issues.
• Support QA metrics reporting and trend analysis for stakeholders.

Skills

Quality Assurance

Audit Management

Regulatory Compliance

Leadership

Risk Analysis

Interpersonal skills

Education

Bachelor's Degree

Tools

Word

Excel

Databases

Job description

IQVIA is seeking an experienced QA leader in Indianapolis to oversee audit programs, ensure regulatory compliance, and drive quality improvements across regional and global QA activities. You will mentor teams, author SOPs, host customer audits, and coordinate with development groups to interpret regulations and corporate standards.

The role emphasizes strong leadership, risk analysis, and cross-functional collaboration.