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 standardsDemonstrated experience supporting audits, inspections, and regulatory interactionsProven ability to interpret regulations and develop compliant policies and procedureStrong regulatory interpretation and decision‑making skillsAbility to influence cross‑functional stakeholdersExperience leading quality system improvementExcellent communication and documentation skillsProven people leadership and team development capability

Working Conditions

Primarily office‑based with extended time at a computer workstationLimited travel (