QC Compliance Lead: Audit & Quality Champion

Simtrabps; Bloomington (IN); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2:

Paid Holidays

Paid Time Off

Education Assistance Program

Job summary

Simtra BioPharma Solutions is seeking a QC Compliance Lead to oversee quality compliance activities within the QC organization, ensuring regulatory and client expectations are met. The role drives continuous improvement and partners on quality risk management across QC functions.

The candidate will lead audits, draft SOPs, monitor regulatory changes, and coordinate plans with QC teams to ensure inspection readiness. Strong science background and 5+ years in quality are required.

Qualifications

• Bachelor’s degree in a physical science required.
• Minimum of 5 years of experience in Quality.
• Previous client/regulatory audit experience preferred.
• Proficiency in Word, Excel, Outlook and enterprise software (e.g., JDE, BPLM, Pilgrim, Trackwise).

Responsibilities

• Acts as the QC Compliance lead.
• Provide guidance and leadership for QC compliance risks.
• Prioritize workloads based on compliance risk.
• Assist in client responses and regulatory audits.
• Authors SOP revisions and CI documentation.
• Review regulatory changes affecting QC.

Skills

Quality management

Audits

Regulatory awareness

Education

Bachelor’s degree in a physical science

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions is seeking a QC Compliance Lead to oversee quality compliance activities within the QC organization, ensuring regulatory and client expectations are met. The role drives continuous improvement and partners on quality risk management across QC functions.

The candidate will lead audits, draft SOPs, monitor regulatory changes, and coordinate plans with QC teams to ensure inspection readiness. Strong science background and 5+ years in quality are required.