Site Quality Director - Limerick

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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Limerick, Ireland

Job Description:

About Vision

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Johnson & Johnson Vision Care are recruiting for a Site Quality Director located in Limerick:

The responsibilities and the impact YOU will have:

• 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.

We would love to hear from YOU, if you have the following essential requirements :

EXPERIENCE & EDUCATION

• 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.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES AND AFFILIATIONS

• Advanced degree or postgraduate qualification in Quality, Engineering, Science, or a related discipline preferred.
• Comprehensive understanding of principles and concepts of Process Excellence, Statistical Process Control, Manufacturing, Sterilization, Quality Assurance and Applied Statistics. Data driven.
• Thorough knowledge of FDA and International Regulatory requirements.
• Excellent organizational, interpersonal, written and oral communication skills required.
• In-depth working knowledge of quality and operations systems and processes.
• Demonstrated excellence in presentation and meeting facilitation skills.
• Proven leadership and problem-solving skills
• Innovative development techniques and strategic thinking abilities
• Ability to prioritize and handle multiple tasks, and to facilitate and resolve cross functional activities and issues.
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

LOCATION & TRAVEL REQUIREMENTS

• Location: Limerick, Ireland
• Travel: Up to 10% of the time

Are you ready to make an impact?

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

Preferred Skills:

• Compliance Management
• Consulting
• Corrective and Preventive Action (CAPA)
• Developing Others
• Fact-Based Decision Making
• Give Feedback
• Good Manufacturing Practices (GMP)
• Inclusive Leadership
• ISO 9001
• Leadership
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Standards
• Quality Validation
• Risk Assessments
• Standard Operating Procedure (SOP)
• Succession Planning
• Tactical Thinking

Base pay range:

€104,000.00 - €179,515.00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.