QC Compliance Lead - Quality & Audit Leader

Simtra US LLC; Bloomington (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Day One Benefits

401(k) Retirement Savings Plan with 2H

Paid Time Off and holidays

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, Indiana seeks a QC Compliance Lead to oversee quality compliance activities within QC, ensuring regulatory adherence and client satisfaction. This role drives audits, continuous improvement, and risk management across the QC function.

The candidate will guide risk-based prioritization, support audit responses, and author SOP revisions, while collaborating with multiple teams to uphold high standards for patient safety and product quality.

Qualifications

• Bachelor's degree in a physical science.
• Minimum of 5 years of experience in Quality.
• Experience with client/regulatory audits preferred.
• Proficient in Word, Excel, and Outlook; able to use enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise).

Responsibilities

• Act as the QC Compliance lead.
• Provide guidance and leadership for QC quality compliance risks.
• Prioritize workloads based on compliance risk.
• Aid in client responses and corrective actions based on client findings.
• Participate in Client and Regulatory audits.
• Authors SOP revisions and CI-related documents.
• Review regulatory changes affecting QC.
• Communicate with QC groups to plan regulatory and client compliance.

Skills

Quality compliance

Audit coordination

Regulatory knowledge

Education

Bachelor's degree in physical science

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, Indiana seeks a QC Compliance Lead to oversee quality compliance activities within QC, ensuring regulatory adherence and client satisfaction. This role drives audits, continuous improvement, and risk management across the QC function.

The candidate will guide risk-based prioritization, support audit responses, and author SOP revisions, while collaborating with multiple teams to uphold high standards for patient safety and product quality.