QC Compliance Lead — Quality & Regulatory Assurance

Simtra US LLC; Bloomington (IN); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Time Off Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN, is seeking a QC Compliance Lead to oversee quality compliance activities within Quality Control, ensuring regulatory adherence and client expectations. The role provides leadership in audits, CI, and continuous improvement, collaborating with cross-functional teams to manage quality and compliance risks across QC.

Requires a physical sciences degree, 5+ years in quality, and audit experience; strong MS Office and enterprise software skills are

Qualifications

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

Responsibilities

• Acts as the QC Compliance lead.
• Provides guidance, support, direction and leadership for compliance risks in the QC group.
• Prioritizes workloads and assigns duties based on risk.
• Aids in client responses and corrective actions based on findings.
• Participates in Client and Regulatory audits.
• Authors SOP revisions and CI documentation.
• Reviews regulatory changes and shifts in focus of agencies.
• Communicates with QC to plan regulatory and client compliance.

Skills

Quality compliance

Regulatory audits

Leadership

Education

Bachelor's degree in a physical science

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN, is seeking a QC Compliance Lead to oversee quality compliance activities within Quality Control, ensuring regulatory adherence and client expectations. The role provides leadership in audits, CI, and continuous improvement, collaborating with cross-functional teams to manage quality and compliance risks across QC.

Requires a physical sciences degree, 5+ years in quality, and audit experience; strong MS Office and enterprise software skills are