QC Compliance Lead - Quality & Regulatory Audits

Simtra-Biopharma-Solutions; Bloomington (IN); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical & Dental

401(k) Plan

Paid Time Off

Life Insurance

Disability Insurance

Job summary

Simtra BioPharma Solutions is seeking a QC Compliance Lead to oversee quality compliance activities within the Quality Control organization, ensuring adherence to regulatory requirements and internal standards. You will lead compliance efforts, support audits and inspections, and drive continuous improvement across QC functions.

The role requires a Bachelor’s degree in a physical science and at least 5 years of quality experience, with preferred prior audit experience and proficiency in MS

Qualifications

• Bachelor's degree in a physical science required.
• Minimum of 5 years of experience in Quality.
• Previous client/regulatory audit experience preferred.

Responsibilities

• Oversee quality compliance activities within the Quality Control organization.
• Provide compliance leadership and support audits/inspections.
• Drive continuous improvement initiatives and manage quality/compliance risks across QC.

Skills

Quality Assurance

Regulatory Audits

Documentation & SOPs

Microsoft Office

Education

Bachelor's degree in 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 Quality Control organization, ensuring adherence to regulatory requirements and internal standards. You will lead compliance efforts, support audits and inspections, and drive continuous improvement across QC functions.

The role requires a Bachelor’s degree in a physical science and at least 5 years of quality experience, with preferred prior audit experience and proficiency in MS