Director, QA-VI Operations

PCI Pharma Services; Bedford (NH); Presencial; USD 140.000 - 190.000; Tempo integral

Resumo da vaga

PCI Pharma Services in Bedford, NH is seeking a senior QA-VI leader to build and scale a site-wide quality-visual inspection organization. You will drive modernization of the AVI program, sign off on complex quality-system investigations, and ensure cGMP compliance across the site.

You will lead a cross-functional team, manage risk assessments and metrics, and partner with senior management to sustain product safety and supply continuity.

Qualificações

• Bachelor’s degree in a relevant scientific discipline.
• Minimum 10 years’ experience in GMP pharmaceutical or biotech industry, with 5+ years in a Quality-based role.
• Prior management experience in manufacturing, visual inspection, labeling/packaging, or QA/QC of sterile drug product.
• Strong understanding of regulatory visual inspection compendium and pharmacopeial standards.

Responsabilidades

• Build, coach, and scale a site-wide QA-VI organization with clear performance expectations.
• Lead the validation and implementation roadmap for advanced technologies including AVI equipment.
• Drive risk-based decisions and manage major investigations and CAPAs.
• Ensure robust cGMP compliance and audit readiness across QA-VI functions.
• Partner with cross-functional leadership to optimize final product inspection and defect management.
• Travel between local Bedford, NH facilities as needed.

Conhecimentos

Leadership

QA/VI expertise

Regulatory knowledge

Strategic planning

Cross-functional collaboration

Formação

Bachelor’s Degree in relevant scientific discipline

Ferramentas

MS Office (Word, Excel)

Descrição da vaga

PCI Pharma Services in Bedford, NH is seeking a senior QA-VI leader to build and scale a site-wide quality-visual inspection organization. You will drive modernization of the AVI program, sign off on complex quality-system investigations, and ensure cGMP compliance across the site.

You will lead a cross-functional team, manage risk assessments and metrics, and partner with senior management to sustain product safety and supply continuity.