Site Quality Head

Inflow Partnership; New Jersey; On-site; USD 180,000 - 280,000; Full time

Job summary

Inflow Partnership seeks a Site Quality Head for a new sterile injectable manufacturing site in New Jersey. The role reports to the Chief Technical Officer and leads the site Quality Management System to meet FDA/EMA/ICH and EU Annex 1 standards.

You will build a cross-functional quality organization across QA, QC, Microbiology and Document Control, ensuring patient safety and continuous improvement while interfacing with regulators, customers and auditors.

Qualifications

• Experience building and leading QMS for sterile products.
• Knowledge of FDA, EMA, ICH, EU Annex 1 and cGxP requirements.
• Strong track record in regulatory inspections and audits.

Responsibilities

• Build and lead the site QMS for a new sterile injectable facility.
• Ensure compliance with FDA, EMA, ICH and EU Annex 1/cGxP.
• Lead regulatory inspections, audits, risk management and QA decisions.
• Establish batch release, deviations, CAPA, change control, complaints and disposition.
• Develop QA, QC, Microbiology and Document Control teams with a culture of patient safety.

Skills

Quality management

Regulatory compliance

Quality systems

Audit readiness

Cross-functional leadership

Job description

Our client is a sterile pharmaceutical manufacturing company looking for a Site Quality Head for their New Jersey site, currently in a start-up / scale-up phase.

This role will report directly to the Chief Technical Officer.

Responsibilities:

• Build and lead the site Quality Management System (QMS) for a new sterile injectable manufacturing facility, ensuring compliance with FDA, EMA, ICH, EU Annex 1 and cGxP requirements
• Lead regulatory and inspection readiness, including pre-approval inspections, audits, quality risk management and critical quality decisions
• Establish and oversee key quality processes including batch release, deviations, CAPA, change control, complaints and product disposition
• Build and develop the site Quality organisation across QA, QC, Microbiology and Document Control, embedding a strong culture of patient safety, compliance and continuous improvement
• Act as the site’s senior quality authority, partnering with cross-functional teams and serving as the primary interface with regulators, customers and external auditors