Quality Assurance (QA) Manager in Indianapolis, IN, responsible for audit readiness, regulatory compliance, and inspection governance across a highly regulated laboratory environment.
Requirements
- Bachelor's degree in Life Sciences (or equivalent experience)
- 8+ years of experience in a regulated environment (GLP/GCP roles)
- 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
Benefits
- Medical
- Dental
- Vision
- Life
- STD/LTD
- 401(k)
- Paid Time Off (PTO) or Flexible Time Off (FTO)
- Tuition Reimbursement
- Employee Stock Purchase Plan