Global Quality Process Leader for CAPA & Compliance

Johnson & Johnson

Cork

On-site

EUR 153,000 - 264,000

Full time

23 hours ago
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Benefits offered by this job

Annual bonus
Vacation days
Parental leave
Well-being programs

Job summary

Johnson & Johnson is seeking a Head of Global Process Management in Ireland to lead end-to-end Quality processes, including CAPA, deviations, change control, QMS, and risk management across a global network. You will partner with Quality, Manufacturing, R&D, Regulatory, and Digital/IT to drive standardization and sustainable improvements.

The role requires 12+ years in regulated industries, 7+ years of people management, and deep GMP/GCP/GLP knowledge, with experience in electronic QMS and data

Qualifications

  • Bachelor's degree in life sciences, engineering, pharmacy, or a related scientific discipline.
  • At least 12 years of progressive experience in pharmaceuticals, biotechnology, medical devices, or another highly regulated industry, including significant experience leading global Quality processes or systems.
  • At least 7 years of people management experience, including leadership of global teams.
  • Deep knowledge of Good Practice requirements, including GMP, GCP, and GLP, as well as global regulatory expectations.
  • Expertise in Quality Management Systems, including CAPA, deviations and non-compliance, change control, investigations, document management, and training.
  • Strong understanding of Quality Risk Management and industry practices in end-to-end Quality process design.
  • Experience with electronic Quality Management System platforms and digital workflow configuration.
  • Knowledge of data integrity, global data standards, metadata management, and audit-trail requirements.
  • Demonstrated ability to translate multi-year strategy into prioritized roadmaps, governance, milestones, and measurable outcomes.

Responsibilities

  • Lead design, governance, digital enablement, and continuous improvement of global Quality processes (CAPA, deviations, non-compliance, change control, QMS).
  • Translate enterprise strategy into clear standards and performance measures; use data to identify risks and opportunities.
  • Support audits and inspections and partner across Quality, Manufacturing, R&D, Regulatory, and Digital/IT to drive adoption and outcomes.
  • Build alignment across regions and functions to balance enterprise consistency with local needs.
  • Lead, coach, and develop global teams and foster an inclusive, high-performing environment.

Skills

Leadership
Change leadership
Stakeholder management
Data analysis
Quality systems
Global teams

Education

Bachelor's degree in life sciences/engineering/pharmacy
Advanced degree (Masters/PhD/MBA/PharmD)

Tools

QMS software
Digital workflow tools

Job description

Johnson & Johnson is seeking a Head of Global Process Management in Ireland to lead end-to-end Quality processes, including CAPA, deviations, change control, QMS, and risk management across a global network. You will partner with Quality, Manufacturing, R&D, Regulatory, and Digital/IT to drive standardization and sustainable improvements.

The role requires 12+ years in regulated industries, 7+ years of people management, and deep GMP/GCP/GLP knowledge, with experience in electronic QMS and data

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