Vice President - Corporate Quality Assurance

Vice President - Corporate Quality Assurance

Location: Roscommon, Ireland (with travel to India on a mandatory quarterly basis)

Employment Type: Permanent, Executive Leadership Role

Overview

A leading global healthcare manufacturing organisation is seeking an experienced Vice President - Corporate Quality Assurance to lead a major quality transformation programme across its international manufacturing network.

This is a strategic enterprise-level role responsible for strengthening the global Quality Management System (QMS), improving regulatory readiness, reducing quality risks, and building a world class quality culture. The successful candidate will have 5 direct reports within the Corporate QA team.

In addition, the VP - Corporate Quality Assurance will provide dotted line oversight to Site QA Heads across our global manufacturing locations - 3 Site Leads.

The position will oversee quality governance across manufacturing sites globally - Operational facility: India - 3 facilities Ireland 1 site, USA 1 site.

Key Responsibilities Corporate Quality Leadership & QMS Transformation

• Lead and develop the Corporate Quality Assurance function across multiple global manufacturing sites.
• Establish and maintain a harmonised global Quality Management System aligned with medical device and healthcare regulatory requirements.
• Standardise quality processes, procedures, documentation, and performance metrics across sites.
• Drive continuous improvement initiatives to enhance quality maturity and compliance.

Digital Quality Transformation

• Lead the implementation and deployment of an enterprise eQMS platform across global operations.
• Manage digital quality transformation activities including system design, validation, data migration, user adoption, governance, and ongoing optimisation.
• Ensure compliance with data integrity requirements and computer system validation standards.

Regulatory Compliance & Inspection Readiness

• Own global regulatory compliance strategy and ensure ongoing inspection readiness.
• Lead regulatory inspections, customer audits, and quality assessments.
• Ensure compliance with applicable medical device and healthcare regulations including ISO 13485, EU MDR, FDA requirements, and global quality standards.

Complaint, CAPA & Risk Management

• Provide strategic oversight of product complaints, investigations, CAPA systems, deviations, and risk management processes.
• Lead reduction of recurring quality issues through robust root cause analysis and preventative action.
• Provide governance for recalls, field safety corrective actions, and post market surveillance activities.

Leadership & Stakeholder Management

• Provide strategic direction and mentorship to Quality teams globally.
• Partner with Manufacturing, Engineering, Regulatory Affairs, R&D, Supply Chain, and Operations leaders.
• Influence senior stakeholders and promote a proactive, customer focused quality culture.

Candidate Profile

The ideal candidate will be an established Quality leader with significant experience within a highly regulated healthcare, medical device, pharmaceutical, or combination product manufacturing environment.

Essential Experience:

• 15+ years' experience in Quality Assurance leadership roles within regulated manufacturing.
• Proven experience leading corporate or multi site quality functions.
• Strong background in medical devices, implantable devices, sterile products, or combination products.
• Experience managing global regulatory inspections and customer audits.
• Demonstrated success improving quality performance through CAPA reduction, complaint management, risk mitigation, and process improvement.
• Hands on experience implementing digital quality systems (eQMS) such as MasterControl, TrackWise, or similar platforms.
• Strong understanding of:
  • ISO 13485
  • EU MDR
  • FDA Quality System Regulations
  • GMP requirements (where applicable)
  • Post market surveillance and device vigilance

Qualifications

• Degree in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, Quality, or related discipline.
• Quality certifications such as ISO 13485 Lead Auditor, ASQ CQA/CMQ, Lean Six Sigma, or equivalent are advantageous.

Key Attributes

• Strategic and transformational leadership approach.
• Ability to operate at executive level and influence business decisions.
• Strong crisis management and problem solving capability.
• Excellent communication and stakeholder management skills.
• Ability to build high performing teams and embed a proactive quality culture.

This is an opportunity for an experienced quality executive to play a pivotal role in transforming a global healthcare organisation's quality function, strengthening regulatory confidence, implementing digital quality capabilities, and enabling future growth.