Senior QA Compliance Auditor

Senior QA Compliance Auditor Job Description This position supports clinical research drug development by offering commercial diagnostic laboratory testing services within a highly regulated environment. The successful candidate will have deep expertise and an action-oriented mindset, capable of leading challenging audit activities across the global enterprise to ensure compliance with GCP, CAP/CLIA regulations, and industry standards. Responsibilities + Plan, schedule, and conduct audits across clinical laboratories and operational support functions. + Host and support sponsor-client audits and regulatory inspections. + Perform external audits of suppliers and service providers. + Support audit response development and CAPA implementation, ensuring responsiveness and delivery requirements are met for stakeholders. + Evaluate adherence to SOPs, regulatory requirements, and industry standards. + Lead the response process for audits and inspections, including CAPA development, implementation, and tracking. + Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness. + Support global QA policy implementation and interpretation of regulatory requirements. + Ensure compliance with applicable regulations and internal quality standards. + Participate in global quality initiatives to improve compliance and operational efficiency. + Develop, deliver, and participate in training on audit practices and compliance expectations. + Promote a culture of quality and continuous improvement across teams. + Prepare detailed audit reports with actionable recommendations. + Track and report quality metrics, identifying trends and areas for improvement. + Maintain audit records and ensure inspection readiness. Essential Skills + Quality Assurance + Audit + Quality control + Drug development + Internal control + FDA compliance + CAPA + Auditing + Clinical laboratory testing + Regulatory compliance + GXP + GMP Manufacturing + ISO Certified Auditor + Risk Management Additional Skills & Qualifications + Bacheloru2019s degree in life sciences or related field; advanced degree preferred. + Minimum of 6 years in a regulatory or GxP-compliant environment. + Proven experience with quality systems and regulatory inspections. + Strong communication, organizational, negotiation, and problem-solving skills. + Ability to influence cross-functional teams and drive compliance initiatives. + Proficiency with quality management system applications and/or platforms (e.g., Veeva, TrackWise) is a plus. + ASQ Certified Quality Auditor (CQA) preferred. + ASQ Certified Quality Manager or Quality Engineer (CQM/CQE) preferred. + SQA Registered Quality Assurance Professional (RQAP) preferred. Work Environment This role requires candidates to be based in Indianapolis and will involve working in an office setting. The environment is highly regulated, focusing on clinical laboratory testing and bioanalysis services. The position supports a culture of quality and continuous improvement, requiring collaboration with cross-functional teams. Job Type & Location This is a Contract to Hire position based out of Indianapolis, IN. Pay and Benefits The pay range for this position is $43.26 - $43.26/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Indianapolis,IN. Application Deadline This position is anticipated to close on Mar 6, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email ( ) for other accommodation options.

Created: 2026-02-23