Senior Supplier Quality Assurance Lead

Automatic Data Processing, Inc.; Boca Raton (FL); Presencial; USD 95.000 - 115.000; Jornada completa

Descripción de la vacante

PharmaLogic in Boca Raton, FL seeks a Supplier Quality Assurance Manager to oversee supplier quality for U.S. PET drug manufacturing operations. The role leads a team of auditors, drives risk-based supplier classification, audits, and Quality Agreements in compliance with CGMP and FDA guidance.

You will manage supplier qualification, CAPA closure, and change control, coordinating with Operations and Supply Chain while traveling up to 50% to support inspections and audits.

Formación

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

Responsabilidades

• Own the risk-based supplier quality program in alignment with ICH Q9(R1) and Q10; manage ASL, supplier records, and related SOPs.
• Lead the audit team: hire, develop, review reports, and calibrate practices.
• Execute supplier qualification and annual risk-based audit schedule with remote/on-site audits.
• Embed quality requirements in sourcing and purchasing; govern supplier selection decisions and improvements.
• Maintain Quality Agreements with suppliers and contract service providers.
• Manage supplier non-conformances and SCARs; drive root-cause, CAPA, and timely closure.
• Control supplier changes and COA reliance; track impact on specifications and regulatory filings.
• Maintain KPIs and scorecards; report risks to leadership and management reviews.
• Assess sole-source and continuity risk with mitigation plans.

Conocimientos

Analytical skills

Negotiation skills

Communication skills

Leadership

Auditing

GxP knowledge

Travel readiness

Educación

Bachelor’s degree in Chemistry/ Biology/ Pharmacy/ Engineering/ Quality Management

Herramientas

eQMS supplier modules

ERP supplier controls

Descripción del empleo

PharmaLogic in Boca Raton, FL seeks a Supplier Quality Assurance Manager to oversee supplier quality for U.S. PET drug manufacturing operations. The role leads a team of auditors, drives risk-based supplier classification, audits, and Quality Agreements in compliance with CGMP and FDA guidance.

You will manage supplier qualification, CAPA closure, and change control, coordinating with Operations and Supply Chain while traveling up to 50% to support inspections and audits.