Quality Assurance (QA) Manager
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Job Location:
Indianapolis, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
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 followup actions.
- Analyze quality data and KPIs to drive process improvement initiatives.
- Facilitate quarterly quality metrics reviews and management reviews.
People & Stakeholder Leadership
- Influence crossfunctional 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 thirdparty activities meet applicable regulatory and quality standards.
Required Qualifications
- Bachelors degree in Life Sciences (or equivalent experience)
- 8 years of experience in a regulated environment (GLP/GCP roles)
Additional Job Standards:
- 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 decisionmaking skills
- Ability to influence crossfunctional stakeholders
- Experience leading quality system improvement
- Excellent communication and documentation skills
- Proven people leadership and team development capability
Working Conditions
- Primarily officebased with extended time at a computer workstation
- Limited travel (<5%)
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 ICHGCP.
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 PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible toparticipatein the 401(k) Plan only. Employees who are regularly scheduled toworka 7 on/7 off schedule are eligible to receive all the foregoing benefits except PTO or FTO. For more detailed information pleaseclick here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race religion color national origin sex (including pregnancy childbirth or related medical conditions) family or parental status marital civil union or domestic partnership status sexual orientation gender identity gender expression personal appearance age veteran status disability genetic information or any other legally protected characteristic. Additionally all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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Required Experience:
Manager
Key Skills
About Company
Labcorp helps patients, providers, organizations, and biopharma companies to guide vital healthcare decisions each and every day.
