Remote Supplier Quality Assurance Leader

PHARMALOGIC HOLDINGS; Boca Raton (FL); Remote; USD 95,000 - 115,000; Full time

Job summary

PHARMALOGIC HOLDINGS is seeking a Supplier Quality Assurance Manager to lead quality oversight for U.S. PET drug manufacturing operations. You will own the risk-based supplier quality program, manage audits, and drive CAPA across suppliers and contract labs.

Reporting to the Director, 212 Manufacturing Quality & Regulatory, you will build a high-performing audit team, embed quality in sourcing, and ensure compliance with FDA guidance and ICH standards. Travel up to 50% is expected.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Engineering, Quality Management, or related field.
• 7+ years of QA in an FDA-regulated pharma environment with 3+ years in supplier quality.
• 3+ years of people leadership, supervising auditors or QA staff.
• Lead auditor experience and building risk-based supplier programs.
• Knowledge of 21 CFR Parts 210, 211, 212; ICH Q9/Q10; FDA guidance on Quality Agreements.
• Strong analytical, negotiation, and communication skills.
• Travel up to 50%.

Responsibilities

• Own the supplier quality program in line with ICH Q9(R1) and Q10, including SOPs, ASL, and eQMS supplier records.
• Lead the audit team: hire, develop, and evaluate auditors; maintain training and qualification programs.
• Execute supplier qualification and annual audit schedule; manage CAPA closure and reassignment based on risk.
• Embed quality requirements in sourcing and purchasing; represent Quality in supplier decisions.
• Maintain Quality Agreements and manage change notifications, deviations, and audit rights.
• Manage supplier NCR/OOS/MCR investigations and CAPA, recording outcomes.
• Serve as supplier oversight SME for FDA inspections and customer audits.

Skills

Lead auditor experience

People leadership

Analytical skills

Negotiation

Communication

Education

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

Tools

eQMS

ERP systems

Job description

PHARMALOGIC HOLDINGS is seeking a Supplier Quality Assurance Manager to lead quality oversight for U.S. PET drug manufacturing operations. You will own the risk-based supplier quality program, manage audits, and drive CAPA across suppliers and contract labs.

Reporting to the Director, 212 Manufacturing Quality & Regulatory, you will build a high-performing audit team, embed quality in sourcing, and ensure compliance with FDA guidance and ICH standards. Travel up to 50% is expected.