Quality Operations Lead – Focus Factory

Simtra BioPharma Solutions; Bloomington (IN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with 3%

Paid Holidays

Paid Time Off

Education Assistance Program

Job summary

Simtra BioPharma Solutions seeks an Associate Director of Quality Operations to lead end-to-end quality for the Focus Factory, ensuring cGMP compliance, timely batch disposition, and risk-based decision-making. This leadership role drives CAPA effectiveness, inspection readiness, and cross-functional partnerships with Manufacturing, Regulatory, and Supply Chain.

The candidate will guide budget, staffing, and training, fostering a culture of ownership and continuous improvement while maintaining

Qualifications

• Bachelor's degree in Life Science or related field required; advanced degree preferred.
• Minimum 8 years’ experience in Quality or pharmaceutical industry.
• Minimum 5 years’ experience in a management role.
• Experience with enterprise software and QA systems.

Responsibilities

• Provide end-to-end quality operations leadership for the Focus Factory.
• Oversee deviations, CAPAs, batch disposition, and regulatory readiness.
• Partner with cross-functional teams to ensure compliance and patient safety.
• Support audits and client/regulatory inspections as needed.

Skills

Leadership

Quality mindset

Cross-functional collaboration

Regulatory awareness

Education

Bachelor's degree in Life Science

Advanced degree preferred

Tools

Microsoft Word

Excel

Outlook

JDE

BPLM

Pilgrim

Trackwise

Job description

Simtra BioPharma Solutions seeks an Associate Director of Quality Operations to lead end-to-end quality for the Focus Factory, ensuring cGMP compliance, timely batch disposition, and risk-based decision-making. This leadership role drives CAPA effectiveness, inspection readiness, and cross-functional partnerships with Manufacturing, Regulatory, and Supply Chain.

The candidate will guide budget, staffing, and training, fostering a culture of ownership and continuous improvement while maintaining