Quality Assurance; QA Manager

Position: Quality Assurance (QA) Manager
** 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 (