Global Quality Process Leader & eQMS Strategy

Jobtailor; New Jersey; On-site; USD 180,000 - 250,000; Full time

Job summary

Jobtailor in the United States is seeking a senior leader to drive global Quality processes, including CAPA, deviations, change control, and QMS optimization. You will partner with cross-functional teams to align Quality strategy with regulatory expectations and operational needs across a global network.

Role requires deep GxP knowledge, strong leadership, and experience guiding enterprise transformations within regulated environments.

Qualifications

• Requires leadership of global teams and enterprise processes in a regulated environment.
• Deep expertise in GxP and global regulatory expectations (FDA/EMA/ICH).
• Proven ability to influence senior stakeholders and drive enterprise alignment.
• Experience with digital Quality systems, investigations, and training programs.

Responsibilities

• Lead global process ownership and governance for enterprise Quality processes including CAPA, deviations, change control, and quality systems.
• Define and maintain global process standards, roles, governance forums, and performance expectations.
• Partner with cross-functional leaders to align Quality strategy with regulatory and operational needs.
• Drive simplification and continuous improvement to reduce variability and improve cycle times.
• Provide strategic leadership for digital Quality systems and eQMS optimization.
• Establish and monitor global Quality metrics, dashboards, and management reviews.
• Support regulatory inspections and remediation activities to meet global requirements.
• Lead councils and change-management efforts to drive adoption across a matrixed organization.

Skills

Global leadership

Quality systems

CAPA

Deviations / non-conformance

Change control

Regulatory knowledge

Stakeholder communication

Digital QMS

Data integrity

GxP knowledge

Education

Bachelor’s degree in Life Sciences/Engineering/Pharmacy

Advanced degree preferred (MS/MBA/Ph.D./Pharm.D.)

Tools

eQMS platforms

Job description

Jobtailor in the United States is seeking a senior leader to drive global Quality processes, including CAPA, deviations, change control, and QMS optimization. You will partner with cross-functional teams to align Quality strategy with regulatory expectations and operational needs across a global network.

Role requires deep GxP knowledge, strong leadership, and experience guiding enterprise transformations within regulated environments.