GMP Quality Lead – Biopharma Manufacturing

Simtrabps; Bloomington (IN); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Day One Benefits

Medical & Dental Coverage

401(k) Match

Time Off Program

Education Assistance

Employee Assistance Program

Onsite Campus Amenities

Job summary

Simtra BioPharma Solutions is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, Indiana. The role provides direct support to Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, by supervising QALO personnel and guiding quality oversight on the production floor.

The successful candidate will lead training and development, drive rapid quality-first decisions with cross-functional teams, and ensure compliance

Qualifications

• Bachelor’s degree in a science discipline or equivalent experience.
• Minimum 2 years of leadership in quality/manufacturing or GXP.
• Solid knowledge of FDA CFR 210/211, GDP and regulatory docs.
• Experience with environmental monitoring and aseptic processes.
• Strong communication and problem-solving skills.

Responsibilities

• Lead EM and QALO activities to assure product quality.
• Oversee training, hiring and performance evaluation of staff.
• Provide rapid, quality-first decision-making with cross-functional teams.
• Ensure SOPs, batch records and investigations are accurate and compliant.
• Maintain audit readiness and regulatory compliance for site quality.

Skills

Leadership

FDA CFR 210/211

GDP Knowledge

Environmental Monitoring

Quality Oversight

GxP Experience

Education

Bachelor’s degree in a science discipline

Tools

D365

Blue Mountain

Veeva

Job description

Simtra BioPharma Solutions is seeking a Quality Supervisor to join the Quality Assurance Leadership Team in Bloomington, Indiana. The role provides direct support to Environmental Monitoring, QALO and Manufacturing to ensure finished products meet specifications, by supervising QALO personnel and guiding quality oversight on the production floor.

The successful candidate will lead training and development, drive rapid quality-first decisions with cross-functional teams, and ensure compliance