Associate QA 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

Job Overview

Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives. Manage the quality assurance oversight of projects, assignments, training and staff.

Job Overview

Provide insight which is exercisable across the large part of the organization or by managing a team of managers by influencing outcomes. Oversee & coordinate assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives. Manage the quality assurance oversight of projects, assignments, training and staff.

Essential Functions

• Plan, schedule, conduct, report and close audit activities, as assigned
• Provide Quality Assurance support, guidance and management of Quality Issues, as assigned
• Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
• Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
• Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
• Host customer audits and participate in review of corrective action plans,as assigned
• Recommend systems for audit, write systems audit plans, coordinate scheduling, conduct, reporting and closure of internal system audits
• Serve as the QA Contact for assigned internal/external customers and IQVIA functional areas
• Oversee documentation, reporting, and closure of compliance issues
• Support Quality Management in proposal reviews and reporting QA metrics
• Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
• Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
• Participate in or lead (cross functional) teams for special projects as assigned
• Promote the concept of quality, the principles of quality management and devise and implement quality improvements

Qualifications

• Bachelor's Degree Pref
• 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience. Equivalent combination of education, training and experience.
• Knowledge of word-processing, spreadsheet, and database applications.
• Strong knowledge of pharmaceutical research and development processes and regulatory environments.
• Considerable knowledge of quality assurance processes and procedures'.
• Strong interpersonal skills and the ability to positively influence and guide others.
• Excellent problem solving, risk analysis and negotiation skills.
• Effective organization, communication, and team orientation and leadership skills.
• Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
• Demonstrated ability to lead and manage multiple responsibilities.
• Identify functional constraints and identify solutions.
• Ability to coordinate timelines with internal customers and external vendors.
• Ability to manage multiple activities and timelines.
• Ability to articulate and define departmental needs and processes.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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. Learn more at https://jobs.iqvia.comIQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. The potential base pay range for this role, when annualized, is $88,600.00 - $246,600.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or 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.