Quality Operations Executive, Focus Factory

Simtra US LLC; Bloomington (IN); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 1:

Paid Time Off

Education Assistance Program

Employee Assistance Program

Job summary

Simtra BioPharma Solutions in Bloomington, IN seeks an Associate Director of Quality Operations to own end-to-end quality oversight for the Focus Factory, ensuring cGMP compliance, batch release, and CAPA effectiveness. The role partners across manufacturing, regulatory, and client services to maintain patient safety and product quality.

The incumbent leads quality decisions, oversees deviation investigations, and drives continuous improvement within a 24/7 operations model, reporting to the

Qualifications

• Bachelor's degree in Life Science or related field; advanced degree preferred.
• Minimum 8 years in Quality/pharma; 5+ years in a management role.
• Experience leading Quality Operations, deviation investigations, CAPAs, and batch release.

Responsibilities

• Establish quality priorities and 24/7 coverage models.
• Provide guidance and leadership during daily operations.
• Ensure quality org aligns with site strategy and regulatory expectations.
• Lead client audits and regulatory inspections as needed.
• Drive continuous improvement and right-first-time execution.

Skills

Quality leadership

cGMP knowledge

Leadership

Audits & inspections

CAPA management

Batch disposition

Education

Bachelor's degree in Life Science

Tools

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions in Bloomington, IN seeks an Associate Director of Quality Operations to own end-to-end quality oversight for the Focus Factory, ensuring cGMP compliance, batch release, and CAPA effectiveness. The role partners across manufacturing, regulatory, and client services to maintain patient safety and product quality.

The incumbent leads quality decisions, oversees deviation investigations, and drives continuous improvement within a 24/7 operations model, reporting to the