Vice President – Corporate Quality Assurance

About the Role

A highly respected global healthcare manufacturing company is searching for an experienced Vice President of Corporate Quality Assurance to spearhead a comprehensive quality transformation across its worldwide production facilities. This executive position is crucial in enhancing the global Quality Management System (QMS), increasing regulatory preparedness, minimizing quality risks, and cultivating a premier quality culture within the organization.

This role includes direct leadership over a team of five Corporate QA staff, as well as indirect supervision of Site QA Heads across global sites in India (three facilities), Ireland (one site), and the USA (one site). The VP will manage quality governance and assurance on a multinational level.

Responsibilities

• Direct and expand the Corporate Quality Assurance department spanning multiple international manufacturing sites.
• Create and uphold a unified global QMS that complies with medical device and healthcare regulatory standards.
• Harmonize quality policies, procedures, documentation, and performance indicators across all locations.
• Champion ongoing enhancements to elevate quality maturity and regulatory compliance.
• Lead the rollout and utilization of an enterprise electronic Quality Management System (eQMS) covering digital transformation aspects such as system architecture, validation, data migration, user training, governance, and continuous improvement.
• Ensure adherence to data integrity protocols and computer system validation requirements.
• Develop and manage global regulatory compliance strategies to guarantee persistent inspection readiness.
• Oversee regulatory audits, customer inspections, and quality evaluations globally.
• Maintain compliance with key regulations including ISO 13485, the EU MDR, FDA Quality System Regulations, and other worldwide quality standards.
• Strategically govern product complaints, thorough investigations, CAPA programs, deviations, and risk management mechanisms.
• Lead efforts to reduce recurring quality challenges via root cause analyses and preventive measures.
• Oversee processes related to recalls, field safety corrective actions, and post-market surveillance.
• Provide visionary leadership and mentorship to global quality teams.
• Collaborate closely with leaders in Manufacturing, Engineering, Regulatory Affairs, R&D, Supply Chain, and Operations.
• Influence senior stakeholders and foster an engaged, customer-oriented quality culture.

Candidate Profile

• Extensive Quality Assurance leadership experience exceeding 15 years within regulated manufacturing sectors.
• Track record of leading corporate or multi-location quality operations.
• Expertise in medical devices, implantable products, sterile goods, or combination products.
• Experienced in managing global regulatory inspections and customer audits effectively.
• Proven success enhancing quality metrics through CAPA management, complaint handling, risk strategies, and process optimizations.
• Hands-on with digital quality system implementations, particularly with eQMS platforms like MasterControl or TrackWise.
• Comprehensive knowledge of ISO 13485, EU MDR, FDA Quality System Regulations, GMP standards, and device vigilance including post-market surveillance.

Qualifications

• Bachelor’s degree or higher in Life Sciences, Pharmacy, Biotechnology, Biomedical Engineering, Quality, or a related field.
• Quality certifications such as ISO 13485 Lead Auditor, ASQ CQA/CMQ, Lean Six Sigma, or equivalents are preferred.

Key Qualities

• Strategic thinker with transformational leadership skills.
• Capable of operating at executive levels and influencing major business decisions.
• Strong in crisis management and complex problem-solving.
• Excellent communicator and stakeholder relationship builder.
• Skilled in building strong, motivated teams and fostering an anticipatory quality-driven culture.

Additional Information

This permanent leadership opportunity includes travel commitments to India on a mandatory quarterly basis. The role is based in Roscommon, Ireland, with responsibility over international sites.