Head of Quality Operations US

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

Job summary

Inflow Partnership is seeking a Head of Quality Operations for Drug Substance US, based in New Jersey, reporting to the Global Head of Quality. Lead quality strategy across US Drug Substance sites and ensure regulatory compliance.

You will oversee GMP compliance, harmonise policies, manage audits and inspections, and serve as the quality and compliance expert for US Drug Substance operations.

Qualifications

• Must demonstrate expertise in quality management systems and regulatory requirements across US Drug Substance operations.
• Experience leading GMP/compliance programs and audits in a global pharmaceutical environment.
• Strong leadership, cross-functional collaboration, and ability to drive quality improvements across multiple sites.

Responsibilities

• Lead and strengthen the Quality Management System across all US Drug Substance sites to ensure quality and regulatory compliance.
• Drive harmonisation of quality policies, procedures and best practices with ongoing GMP adherence and global regulatory alignment.
• Provide strategic oversight of audits, inspections, compliance activities and quality improvements in collaboration with Site Quality Heads.
• Act as the principal quality and compliance expert for US Drug Substance operations.

Skills

Quality Management

GMP/Regulatory Compliance

Audits & Inspections

Leadership

Job description

Our client is a leading global pharmaceutical company and they are looking for a Head of Quality Operations, Drug Substance US.

This role is based in New Jersey and will report directly to the Global Head of Quality.

Responsibilities:

• Lead and continuously strengthen the Quality Management System across all US Drug Substance sites, ensuring consistent quality and regulatory compliance
• Drive harmonisation of quality policies, procedures and best practices while maintaining adherence to GMP and global regulatory requirements
• Provide strategic oversight of audits, inspections, compliance activities and quality improvements, working closely with Site Quality Heads
• Act as the key quality and compliance expert for US Drug Substance operations