Job DescriptionAn amazing opportunity has arisen for an Associate Director Quality Assurance at our Ballydine site. You will report to the Quality Director and partner with the Quality Leadership Team to ensure our Drug Substance, Spray Dried Intermediate, and Drug Product are compliant and ready for downstream customers. This is a hands-on, people-centered role where your leadership, judgment, and commitment to continuous improvement will make a real impact.Bring energy, knowledge, innovation to carry out the followingProvide Quality support to the Integrated Process Teams to ensure the facility meets and operates to all Good Manufacturing Practice (GMP) requirements for development, clinical and commercial supply.Participate as a team member in the Documentation Review and Approval Process, Deviation Management Process, Quality Risk Management, Change Control Management and New Product Introduction.Lead and support GMP audits and regulatory inspections (internal, customer, regulatory). Serve as lead auditor for walkdowns and systems audits to maintain compliance and continuous inspection readiness.Accountable for the development and performance of the team, providing input and coaching on professional development. Provide timely feedback and ensure that responsibilities are delivered following appropriate inclusion principles & behaviours.Lead and support Continuous Improvement of Quality and site processes.What Skills You Will NeedIn order to excel in this role, you will more than likely haveDegree or post graduate qualification in Science, Pharmaceutical or Engineering field.Minimum of 5-year experience in the Pharma regulated industry with leadership experience; clinical and commercial GMP experience preferred.Excellent knowledge of regulations and sources of regulatory information.Experience with regulatory inspections.Qualified Person qualification is an advantage.Experience in High Potency Manufacturing, Continuous Manufacturing, Spray Drying, Laboratory GMP and Project Management is desirable.Demonstrated continuous improvement mindset and capabilities.Dynamic individual with excellent organizational skills, who can effectively collaborate with cross functional teams.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.So, if you are ready toInvent solutions to meet unmet healthcare needs, pleaseapply today.Required SkillsAuditing, Collaboration, Continuous Improvement, Leadership, Quality Assurance (QA), Quality Management Systems (QMS), Regulatory Inspections, Risk ManagementPreferred SkillsCurrent Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read CarefullyMerck & 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 StatusRegularRelocationVISA SponsorshipTravel RequirementsFlexible Work ArrangementsNot ApplicableShiftValid Driving LicenseHazardous Material(s)Job Posting End Date01/5/2026A job posting is effective until PM 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.Requisition IDR376246