Senior Supplier Quality QA Lead (GMP & Compliance)

INCOG BioPharma; Fishers (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

INCOG BioPharma is seeking a QA Senior Specialist - Supplier Quality in Fishers, IN to manage supplier qualification and oversight within a GMP environment. You’ll lead evaluation of supplier quality systems, coordinate changes, and collaborate across Purchasing, Quality Operations, and external auditors.

The role demands meticulous attention to detail, strong communication, and ability to balance multiple priorities while ensuring compliance with FDA regulations and INCOG quality standards.

Qualifications

• Bachelor's degree and 3 years experience OR 10+ years of supplier quality management experience.
• Experience with supplier auditing or audit coordination.
• Strong understanding of GMP regulations and QA systems.
• Excellent written and verbal communication skills.

Responsibilities

• Lead the qualification and approval process for new suppliers, evaluating quality systems and GMP compliance.
• Maintain supplier qualification files and approved vendor lists per regulatory requirements.
• Collaborate with Purchasing to ensure only approved materials are procured from qualified vendors.
• Write and revise SOPs governing the Supplier QA system.
• Review and process Supplier Change Notifications (SCNs) and coordinate cross-functional reviews.
• Perform risk-based evaluation of suppliers and supplier issues.
• Investigate and manage supplier complaints.
• Coordinate supplier audits with external audit service providers.
• Support supplier quality agreements and quality documentation.
• Participate in cross-functional teams for new product introductions and quality initiatives.
• Perform Supplier QA metric reporting.

Skills

Attention to detail

Communication

Organizational skills

Problem solving

Team collaboration

Supplier quality experience

Documentation

Education

Bachelor's degree in pharmaceutical/biopharma

Job description

INCOG BioPharma is seeking a QA Senior Specialist - Supplier Quality in Fishers, IN to manage supplier qualification and oversight within a GMP environment. You’ll lead evaluation of supplier quality systems, coordinate changes, and collaborate across Purchasing, Quality Operations, and external auditors.

The role demands meticulous attention to detail, strong communication, and ability to balance multiple priorities while ensuring compliance with FDA regulations and INCOG quality standards.