Vision Care Site Quality Director

Johnson & Johnson

Limerick

On-site

EUR 104,000 - 180,000

Full time

14 days+

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Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Vision Care in Limerick is seeking a Site Quality Director to lead the Quality function at the vision care site. You will drive regulatory compliance, CAPA, and continuous improvement across manufacturing.

You will work with senior leadership to implement quality systems, ensure product release readiness, and maintain audit readiness with global regulators. A strong background in FDA/ISO requirements and team leadership is essential.

Qualifications

Bachelor’s degree in science, engineering, or related technical field.
15+ years in medical device or pharmaceutical quality assurance.
Minimum 10 years in leadership roles.
Experience in a senior quality management role in manufacturing.
Thorough knowledge of FDA and international regulatory requirements.

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.
Serves 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.
Provides leadership and oversight for Validation, Quality Assurance/Compliance, CAPA, Complaint Handling, Microbiology, and Quality Control laboratory functions to ensure operational excellence and regulatory compliance.
Acts as the primary quality representative for regulatory inspections, external audits, and key stakeholder interactions, maintaining effective relationships with regulatory agencies and ensuring audit readiness across the organization
Manages quality function resources, talent development, and departmental budgets to achieve organizational objectives while maintaining compliance and operational effectiveness.
Sign-off authority for changes to procedures, processes, designs, etc.
Authority to act on behalf of top management during the audit
Authority to place products or processes on hold
Responsible for the conformity of the device is checked in accordance with the quality management system under which the devices are manufactured, before a device is released.
Responsible for compliance in accordance with regulations and standards such as and from but not limited to 21 CFR 820; ISO 13485; EU MDD/MDR; Australian Therapeutic Goods Regulations No. 236; Brazil GMP Regulations Resolution RDC 665; CMDR – SOR98‑282; Japan MHLW Ordinance No. 169, FDA Combination Product Regulation 21 CFR Parts 4 with 21 CFR 210/211 as applicable.