Quality Operations Director – Focus Factory

Inuplands; Bloomington (IN); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical & Dental Coverage

401(k) Retirement Savings Plan with公司匹

Paid Holidays

Education Assistance Program

Job summary

Simtra BioPharma Solutions (Simtra) seeks an Associate Director of Quality Operations to lead end-to-end quality oversight for the Focus Factory, ensuring operations comply with cGMP, site procedures, and client commitments. You will guide quality decisions, CAPA, and batch release while driving continuous improvement and risk management.

The role requires strong leadership, cross-functional collaboration, and a focus on patient safety and product quality.

Qualifications

• Bachelor's degree required; Life Sciences preferred; advanced degree valued.
• 8+ years’ experience in Quality or pharmaceutical industry.
• 5+ years’ experience in a management role.
• Proficient in Microsoft Word, Excel and Outlook; experience with enterprise quality systems.

Responsibilities

• Own Focus Factory quality and compliance performance and oversight.
• Provide independent quality decision-making for routine operations, escalations, deviations, CAPA, and inspections.
• Lead reviews and endorsements via Quality Review Board and governance forums.
• Collaborate with Manufacturing, Regulatory, Supply Chain, and Client Services to balance quality and supply.
• Ensure scientifically justified batch dispositions and timely release decisions.

Skills

Quality leadership

Regulatory compliance

CAPA management

Audits

Education

Bachelor's degree in Life Sciences

MBA or related management degree

Tools

Microsoft Word

Excel

Outlook

JDE

TrackWise

Pilgrim

BPLM

Job description

Simtra BioPharma Solutions (Simtra) seeks an Associate Director of Quality Operations to lead end-to-end quality oversight for the Focus Factory, ensuring operations comply with cGMP, site procedures, and client commitments. You will guide quality decisions, CAPA, and batch release while driving continuous improvement and risk management.

The role requires strong leadership, cross-functional collaboration, and a focus on patient safety and product quality.