Director, MSAT Validation & Digital

<p><span>At Johnson &amp; 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</span></p><p></p><p></p><p><b><span><span>Job Function: </span></span></b></p>Supply Chain Engineering<p></p><p></p><p><b><span><span>Job Sub </span></span><span><span>Function: </span></span></b></p>Process Engineering<p></p><p></p><p><b>Job Category:</b></p>People Leader<p></p><p></p><p><b>All Job Posting Locations:</b></p>Ringaskiddy, Cork, Ireland<p></p><p></p><p><b>Job Description:</b></p><p><b>About Innovative Medicine </b></p><p>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.</p><p>Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.</p><p>Learn more at <a href="https://www.jnj.com/innovative-medicine" rel="noopener noreferrer" target="_blank"><span>https://www.jnj.com/innovative-medicine</span></a></p><p></p><p><b>We are searching for the best talent for a Director, MSAT Validation &amp; Digital that can be in either Raritan, NJ or Cork, Ireland.</b></p><p></p><p>An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.</p><p></p><p>Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):</p><p></p><p>USA - Requisition Number: R-020408</p><p>Ireland – Requisition Number: R-020846</p><p></p><p>Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.</p><p></p><p><b>Purpose:</b></p><p>We are seeking a dynamic and innovative Director, MSAT Validation &amp; Digital to spearhead the development and implementation of advanced strategies for validation, automated processing, and digital data capabilities. The successful candidate will focus on advancing and automating critical compliance functions across Advanced Therapies Supply Chain. This role demands a forward-thinking professional with expertise in validation processes and digital transformation who can drive strategic initiatives that elevate compliance and operational efficiency.</p><p></p><p><b>Key Responsibilities:</b></p><p><b>Strategic Development:</b></p><ul><li>Lead the design and implementation of advanced validation strategies and frameworks to ensure compliance with regulatory standards.</li><li>Identify opportunities for process automation and digital solutions that enhance validation and compliance functions.</li></ul><p><b>Automation &amp; Digital Integration:</b></p><ul><li>Develop and deploy automated processing tools to streamline validation workflows, ensuring accuracy and efficiency.</li><li>Collaborate with IT and data management teams to integrate digital capabilities into existing compliance frameworks.</li></ul><p><b>Data Management:</b></p><ul><li>Establish protocols for data integrity, quality assurance, and validation to support compliance objectives.</li><li>Utilize advanced analytics and data visualization techniques to monitor validation processes and compliance metrics.</li></ul><p><b>Core Competency Development:</b></p><ul><li>Enhance organizational capabilities in validation and compliance through training, support, and resource development.</li><li>Mentor and develop a team of validation and compliance professionals, fostering a culture of continuous improvement.</li></ul><p><b>Stakeholder Collaboration:</b></p><ul><li>Work closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and IT, to align validation activities with overall business goals.</li><li>Communicate effectively with stakeholders at all levels to convey validation strategies, progress, and outcomes.</li></ul><p><b>Regulatory Compliance:</b></p><ul><li>Stay abreast of industry regulations and standards, ensuring all validation processes align with current requirements.</li><li>Lead inspections and audits related to validation processes to ensure compliance readiness.</li></ul><p></p><p><b>Qualifications:</b></p><p><b>Required:</b></p><ul><li>Bachelor’s degree in Science, Engineering, Computer Science, or a related field; Master's degree preferred, with 10-12