QC Compliance Lead, Quality Assurance Lab

Socket.dev; Bloomington (IN); On-site; USD 100,000 - 160,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 2%

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking a QC Compliance Lead to oversee quality compliance within the Quality Control organization, ensuring regulatory adherence and client expectations across the QC function.

This role provides leadership for audits, drives continuous improvement, and partners with teams to manage quality risks, SOP updates, and regulatory changes, supporting a robust quality system.

Qualifications

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

Responsibilities

• Acts as the QC Compliance lead.
• Provides guidance, support, direction and leadership for any quality compliance risks for the QC group.
• Prioritizes workloads and assigns duties based on compliance risk.
• Aids in client responses and CIs based on client findings.
• Participates in Client and Regulatory audits.
• Authors SOP revisions and any technical writing documents needed for CI completion.
• Performs review of regulatory changes and shifts in focus of regulatory agencies.
• Communicate with QC groups to determine plan for regulatory and client compliance.

Skills

Quality leadership

Regulatory audits

Client communications

Quality systems

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 within the Quality Control organization, ensuring regulatory adherence and client expectations across the QC function.

This role provides leadership for audits, drives continuous improvement, and partners with teams to manage quality risks, SOP updates, and regulatory changes, supporting a robust quality system.