Senior QA Auditor, GMP & Supplier Quality

PCI Pharma Services; Bedford (NH); On-site; USD 85,000 - 105,000; Full time

Job summary

PCI Pharma Services in Bedford, NH is seeking a Supplier Quality professional to oversee the Supplier Qualification program across PCI facilities. You will schedule and perform audits, manage observations, and ensure quality and regulatory compliance in GMP operations.

Role requires collaboration with the Corporate Supplier Quality team and travel up to 20%. The ideal candidate holds a Science degree with QA GMP experience or substantial related expertise, with strong documentation and

Qualifications

• Bachelor of Science with 5+ years QA GMP experience; or HS diploma with 10+ years in QA GMP.
• Excellent organizational and communication skills.
• Ability to work in fast-paced regulated environment.
• Knowledge of FDA EMA ICH guidelines preferred.

Responsibilities

• Schedule and conduct supplier audits to evaluate SOP and regulatory compliance.
• Track audit observations and ensure timely closure.
• Manage supplier change notifications and non-conformances.
• Draft supplier QA agreements and NDAs.
• Collaborate with Corporate Supplier Quality on initiatives.
• Support supplier risk assessments and Annual Product Quality Review.
• Travel 10–20%.
• Maintain KPI metrics for Supplier Qualification.

Skills

Auditing

QA GMP

Regulatory knowledge

Documentation

Cross-functional teamwork

MS Office

Education

Bachelor of Science

High School diploma with 10+ years QA GMP

Tools

MS Office

Visio

Access

Job description

PCI Pharma Services in Bedford, NH is seeking a Supplier Quality professional to oversee the Supplier Qualification program across PCI facilities. You will schedule and perform audits, manage observations, and ensure quality and regulatory compliance in GMP operations.

Role requires collaboration with the Corporate Supplier Quality team and travel up to 20%. The ideal candidate holds a Science degree with QA GMP experience or substantial related expertise, with strong documentation and