Vision-Driven Site Quality Leader

Biopharma Careers; Limerick; On-site; EUR 104,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson Vision Care in Limerick is seeking a Site Quality Director to lead the Quality organization and ensure regulatory compliance across the site. You will oversee Quality Assurance, CAPA, and audits while shaping the quality culture and continuous improvement initiatives.

The role requires extensive leadership experience in medical device/pharma QA, strong regulatory knowledge, and the ability to manage complex cross-functional programs within a global company.

Qualifications

• Bachelor’s degree in science, engineering, or related technical field.
• 15+ years industry experience working in medical device and/or pharmaceutical quality assurance field.
• Minimum of 10 years in leadership position.
• Experience in a senior quality management role in a medical device or pharmaceutical manufacturing company.
• Advanced degree or postgraduate qualification in Quality, Engineering, Science, or a related discipline preferred.
• Comprehensive understanding of FDA and International Regulatory requirements.
• Excellent organizational, interpersonal, written and oral communication skills.

Responsibilities

• Leads the Quality organization to ensure compliance with applicable regulatory requirements, company policies, and quality standards while driving a culture of quality, risk-based decision making, and continuous improvement across the site.
• Ensures the understanding and implementation of the quality policy, quality objectives, quality metrics, risk management program, regulatory and customer requirements throughout the manufacturing site.
• Serves as Site Management Representative with overall responsibility for the effectiveness of the Quality Management System, including governance, management review, performance reporting, regulatory inspection readiness, and escalation of quality system risks and improvement opportunities to senior management.
• Drives continuous improvement through oversight of quality investigations, performance metrics, trend analysis, CAPA effectiveness, and the application of process excellence and statistical methodologies to address quality risks and improve business performance.
• Acts as a member of the Site Leadership Team, providing strategic direction for the quality function, developing organizational capability, leading cross-functional initiatives, and ensuring quality objectives support site and business priorities.

Skills

Quality leadership

Regulatory knowledge

GMP awareness

CAPA

Education

Bachelor’s degree in science/engineering

15+ years industry experience

Job description

Johnson & Johnson Vision Care in Limerick is seeking a Site Quality Director to lead the Quality organization and ensure regulatory compliance across the site. You will oversee Quality Assurance, CAPA, and audits while shaping the quality culture and continuous improvement initiatives.

The role requires extensive leadership experience in medical device/pharma QA, strong regulatory knowledge, and the ability to manage complex cross-functional programs within a global company.