Senior Supplier Quality QA Lead

American Society for Quality; Fishers, Northern (IN, KY); Hybrid; USD 85,000 - 120,000; Full time

Benefits offered by this job

Paid vacation days

Holiday pay (11 holidays)

401(k) plan with match

Health & wellness plans

FSA/HSA programs

Dental & vision care

Job summary

American Society for Quality is looking for a Senior QA Specialist - Supplier Quality to uphold supplier qualification and GMP compliance across our supply chain. You will work with Purchasing, Quality Operations, and external audit partners to safeguard product quality within the pharmaceutical arena.

In this role you will manage supplier qualification files, supplier change notifications, and supplier complaints while coordinating audits and maintaining robust documentation controls.

Qualifications

• Bachelor's degree or 3+ years in supplier quality in pharma/biopharma/medical devices GMP.
• Experience with supplier auditing or audit coordination.
• Strong GMP knowledge and quality systems requirements for pharmaceutical manufacturing.
• Excellent written and verbal communication skills with internal stakeholders and external suppliers.

Responsibilities

• Lead the qualification and approval process for new suppliers.
• Maintain and manage supplier qualification files and approved supplier lists.
• Collaborate with Purchasing to ensure only approved materials from qualified vendors.
• Write and revise SOPs and other documents 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 with external audit service providers to perform supplier audits.
• Support supplier quality agreements and quality documentation.
• Participate in cross-functional teams for new product introductions and process improvements.
• Perform Supplier QA metric reporting.

Skills

Supplier quality management

GMP regulations

QA documentation

Cross-functional collaboration

Audit coordination

Risk assessment

Analytical/problem solving

Communication skills

Independent work

Education

Bachelor's degree in related field

10+ years supplier quality experience

Tools

QMS software

Document management systems

Job description

American Society for Quality is looking for a Senior QA Specialist - Supplier Quality to uphold supplier qualification and GMP compliance across our supply chain. You will work with Purchasing, Quality Operations, and external audit partners to safeguard product quality within the pharmaceutical arena.

In this role you will manage supplier qualification files, supplier change notifications, and supplier complaints while coordinating audits and maintaining robust documentation controls.