Quality Assurance; QA Manager
Job in
Indianapolis, Marion County, Indiana, 46218, USA
Listed on 2026-03-15
Listing for:
LabCorp
Full Time
position Listed on 2026-03-15
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Quality Assurance (QA) Manager in Indianapolis, IN
Work Schedule:
Monday - Friday 8-5 pm
Job Responsibilities:
Regulatory Compliance & Inspection Readiness
* Provide leadership and governance for audits and inspections across CLS in alignment with ISO 15189, CAP, CLIA, NYS/MOH, and GCP requirements.
* Serve as a primary quality interface with regulatory authorities and clients during audits and inspections.
* Ensure timely escalation of compliance risks and implementation of corrective and preventive actions (CAPA). Quality Systems Oversight
* Ensure consistent implementation, review, and governance of SOPs, policies, and controlled documents.
* Translate regulatory requirements into practical, operational quality controls.
* Maintain oversight of data integrity programs, result corrections, and documentation standards. Audit & Continuous Improvement Leadership
* Lead internal audit programs, inspection preparedness activities, and follow‑up actions.
* Analyze quality data and KPIs to drive process improvement initiatives.
* Facilitate quarterly quality metrics reviews and management reviews. People & Stakeholder Leadership
* Influence cross‑functional stakeholders to improve quality outcomes and operational efficiency.
* Provide coaching, training, and performance feedback aligned to business and regulatory needs. Vendor & External Oversight
* Support vendor qualification, oversight, and issue resolution.
* Ensure third‑party activities meet applicable regulatory and quality standards.
Required Qualifications
* Bachelor's degree in Life Sciences (or equivalent experience)
* 8+ years of experience in a regulated environment (GLP/GCP roles)
Preferred Qualifications:
* Strong working knowledge of laboratory quality systems and regulatory standards
* Demonstrated experience supporting audits, inspections, and regulatory interactions
* Proven ability to interpret regulations and develop compliant policies and procedure
* Strong regulatory interpretation and decision‑making skills
* Ability to influence cross‑functional stakeholders
* Experience leading quality system improvement
* Excellent communication and documentation skills
* Proven people leadership and team development capability Working Conditions
* Primarily office‑based with extended time at a computer workstation
* Limited travel (
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