Quality Assurance (QA) Manager

Labcorp • Indianapolis, IN

5d • Onsite

About The Position

We are seeking an experienced Quality Assurance (QA) Manager to support Clinical Laboratory Services (CLS) with primary accountability for audit readiness, regulatory compliance, and inspection governance across a highly regulated laboratory environment.
The QA Manager plays a pivotal role in maintaining licensure, accreditation, and inspection readiness across multiple regulatory frameworks, including: ISO 15189, CAP, CLIA, NYS / MOH, ICH‑GCP.

Requirements

• Bachelor’s degree in Life Sciences (or equivalent experience)
• 8+ years of experience in a regulated environment (GLP/GCP roles)

Nice To Haves

• 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

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.

Benefits

• Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan.
• Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager