Job DescriptionJoin our team in Dunboyne, Ireland, where we are dedicated to advancing Biologics Drug Substance manufacturing in our cutting-edge research facility. We are looking for an Associate Director, IT Compliance and Systems Management, to lead and oversee the compliance of our IT systems.In this role, you will blend your technical expertise with strong skills in IT compliance and validation. You will champion best practices in computer systems compliance and take ownership of IT systems across multiple laboratories in a fast-paced environment.Key Responsibilities:Ensure the validated state of IT manufacturing and laboratory systems is maintained.Implement a Data Quality Strategy to safeguard GxP data.Lead a support team in managing new system introductions and upgrades.Review digital technology for all systems introduced, ensuring strategic alignment.Engage with lab transformation initiatives for effective technology adoption.Support internal and regulatory audits as needed.Manage IT corrective and preventive actions and software development life cycle activities.Foster a culture of data integrity and quality to protect patients and ensure robust processes.Conduct internal IT compliance and security reviews.Ensure compliance with global standards and corporate requirements.Collaborate with stakeholders to align strategies and service expectations.Connect with industry groups to promote best practices and standards.Your Profile:10 years of experience in the pharmaceutical or biotechnology sector.5 years of experience in quality management or computer systems qualification and validation.Strong technical knowledge of industry processes.Proven leadership and team management experience.Demonstrated project management abilities.An entrepreneurial spirit, self-starter, and hands-on individual.Current Employees apply HERECurrent Contingent Workers apply HERESecondary Language(s) Job Description:We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs. As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process. We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.Please feel free to speak to us about what flexibility means to you during your application or click on the link to find out more about our hybrid working model So, if you are ready to: Invent solutions to meet unmet healthcare needs, please apply today.Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: RegularRelocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:03/11/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.