QC Compliance Lead - Drive Audits & Quality Excellence

Simtra BioPharma Solutions; Bloomington (IN); Sur place; USD 110 000 - 145 000; Plein temps

Avantages offerts par ce poste

Day One Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Time Off Program

Adoption Reimbursement Program

Education Assistance Program

Employee Assistance Program

Onsite Campus Amenities

Gym/Workout Facility

Cafeteria

Credit Union

Résumé du poste

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a QC Compliance Lead to oversee quality compliance within the Quality Control organization, ensuring alignment with regulatory requirements and client expectations. This role drives audits, supports inspections, and leads continuous improvement initiatives.

Join a world-class CDMO with a diverse benefit program and opportunities to partner across teams to mitigate risks and strengthen quality systems while supporting patient safety.

Qualifications

• Bachelor’s degree in a physical science required.
• Minimum of 5 years of experience in Quality.
• Previous client/regulatory audit experience preferred.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Responsabilités

• 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

Connaissances

Quality compliance leadership

Regulatory audits

Documentation management

Strong communication

Formation

Bachelor's degree in a physical science

Outils

JDE

BPLM

Pilgrim

Trackwise

Microsoft Word

Excel

Outlook

Description du poste

Simtra BioPharma Solutions in Bloomington, Indiana, is seeking a QC Compliance Lead to oversee quality compliance within the Quality Control organization, ensuring alignment with regulatory requirements and client expectations. This role drives audits, supports inspections, and leads continuous improvement initiatives.

Join a world-class CDMO with a diverse benefit program and opportunities to partner across teams to mitigate risks and strengthen quality systems while supporting patient safety.