Senior Supplier Quality Assurance Leader - Pharma

PharmaLogic Holdings Corp.; Boca Raton (FL); On-site; USD 95,000 - 115,000; Full time

Job summary

PharmaLogic is seeking a Supplier Quality Assurance Manager in Boca Raton, FL to oversee supplier quality for U.S. PET drug operations.

The role leads a team of auditors, manages qualification processes, and ensures CGMP and FDA compliance across raw materials, contract services, and testing labs. Responsibilities include risk-based program ownership, audit execution, supplier qualification, and change management.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, Quality Management, or a related scientific discipline.
• 7+ years of QA experience in FDA-regulated pharma; 3+ years in supplier quality.
• 3+ years of people leadership, including supervising auditors.
• Lead auditor experience with risk-based supplier program (classification, ASL, scorecards).
• Knowledge of 21 CFR Parts 210, 211, and 212; ICH Q9 and Q10; FDA guidance on Quality Agreements.
• Strong analytical, negotiation, and communication skills.
• Travel up to 50%.

Responsibilities

• Own the risk-based supplier quality program and ASL governance.
• Lead the audit team: hiring, development, and performance reviews.
• Execute supplier qualification and annual risk-based audit schedule.
• Embed quality requirements in sourcing and purchasing decisions.
• Maintain Quality Agreements with suppliers and contract providers.
• Manage supplier NCR/OOS/SCAR investigations and CAPA closure.
• Assess supplier changes and COA reliance; support regulatory filings.
• Maintain supplier quality KPIs and report to leadership.
• Assess sole-source and continuity risk for critical materials.
• Serve as supplier oversight SME for FDA inspections.

Skills

QA experience

Leadership

Auditing

Regulatory knowledge

Communication

Travel readiness

Education

Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, Quality Management, or related

Tools

eQMS

Job description

PharmaLogic is seeking a Supplier Quality Assurance Manager in Boca Raton, FL to oversee supplier quality for U.S. PET drug operations.

The role leads a team of auditors, manages qualification processes, and ensures CGMP and FDA compliance across raw materials, contract services, and testing labs. Responsibilities include risk-based program ownership, audit execution, supplier qualification, and change management.