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 https://www.jnj.com **Job Function:** Quality **Job Sub** **Function:** Quality Systems **Job Category:** Professional **All Job Posting Locations:** Ringaskiddy, Cork, Ireland **Job Description:** **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine **We are searching for the best talent for a Manager within a Quality Systems role to be in** **Cork** **, Ireland.** **As a Manager Quality Systems, you will:** This position manages and leads the activities of the Quality Systems Department at Bio Cork J&J Innovative Medicine. This includes executive roles in managing change control, Non-conformance investigations, documentation management, quality agreements process, complaints system, global standards process and other related quality system elements. **Key Responsibilities** Responsible for appropriately staffing and developing the Quality System organization to meet business needs and succession plans. Provides leadership and direction to the Quality and Site Management Team to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behaviour model. Partners with other IMSC Site Quality Heads to ensure harmonization and alignment with IMSC Quality Policies, Guidelines, Programs and Systems. QSMR & Site Quality Risk Register Lead: Quality Systems Management Review. Owner of the Site Quality Plan. Active member of the QA Operational Leadership Team. Supports the Quality Metrics Program. Provide leadership to direct reports and the site through: Develops and champions an organizational culture that promotes behaviours that lead to superior business performance and organizational excellence. Creates a commitment to customer service. Encourages, supports and directs initiatives and programmes that lead to improved quality and improved regulatory compliance. Manages and guides staff and those involved in quality system activities to achieve the best results. Mentors and coaches’ staff, as well as develops and implements training programmes, to ensure professional and personal development of department personnel. Interfaces professionally with other Business units and departments, as well as staff from other affiliates in fulfilling responsibilities. Ensures all employees comply with all applicable IMSC and governmental regulations, policies and guidelines. **Key Competencies required for this position:** + Degree required in a scientific or engineering discipline. + 5-10 years’ experience in a quality area (e.g. R&D, Operations, MAM, QC, MSAT). + Experience in a significant leadership position within the biological and/or pharmaceutical industry. + Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Proven success in managing in a global organization. **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. **Here’s what you can expect:** Application review: We’ll carefully review your CV to see how your skills and experience align with the role. Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have. Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step. Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! \#LI_Onsite **Required Skills:** **Preferred Skills:** Analytical Reasoning, Analytics Dashboards, Collaborating, Compliance Management, Data Gathering Analysis, Data Quality, Incident Management, Performance Measurement, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, Systems Analysis, Systems Integration, Tactical Planning, Technical Credibility