Job DescriptionThe Specialist, Planning & Scheduling, in Global Clinical Supply (GCS), Global Operations Planning is a technical professional responsible for executing and supporting GxP Quality System activities to ensure clinical supply operations are performed in a compliant, inspection-ready, and risk-based manner. GCS supports Phase I-IV trials across 60+ countries in alignment with applicable GxP regulations (GMP, GDP, and GCP) and Environmental Health & Safety requirements.This role supports core GCS processes - primarily focused on deviations and CAPA, however, support of change control, documentation, training, audits/inspections, analytics, risk management, and safety - working under established procedures and governance structures are developmental opportunities should proficiency be demonstrated across multiple compliance domains.The Specialist partners with GCS functional areas and stakeholders within Operations Planning, Distribution & Logistics, Clinical Supply, Quality, IT/Digital, and other cross-functional teams to support Quality Management System (QMS) execution, issue resolution, and continuous improvement across the GCS network.**Qualifications****Education & Experience:*** Bachelor's degree in a Scientific, Engineering, or related field with 1+ years of relevant experience in a regulated GxP environment.* Experience supporting one or more GxP Quality System processes (e.g., deviations, CAPA, change control, documentation, training, audits/inspections, risk management, safety).* Experience working within cross-functional teams in a regulated environment.**Skill-based Qualifications:**With developing subject matter expertise, strong execution focus, and the ability to follow defined processes and procedures, candidates must demonstrate:* Ability to execute compliance activities in alignment with established GxP procedures and Quality System expectations.* Foundational understanding of GxP and ALCOA+ principles, with the ability to apply data integrity expectations to daily work.* Ability to identify risks to compliance execution, timelines, or deliverables and escalate appropriately.* Ability to support deviation investigations and CAPA activities with accurate documentation and attention to detail.* Ability to collaborate effectively with stakeholders across organizations.* Analytical skills to review data, support trending, and contribute to performance monitoring.* Clear, professional communication skills for written documentation and routine stakeholder interactions.**Preferred Experience and Skills:*** Experience supporting audits, inspections, or readiness activities.* Experience with documentation lifecycle activities (authoring, reviewing, periodic updates).* Experience working with GMP electronic systems (e.g., MEDs, Veeva, TrackWise, LMS).* Interest in continuous improvement or Lean methodologies.**Additional location(s) Compensation Information:****Required Skills:**Adaptability, Analytical Thinking, CAPA Investigations, Conducting Investigations, Cross-Functional Communications, Data Analysis, Driving Continuous Improvement**Preferred Skills:**MRP Systems, Six SigmaCurrent Employees applyCurrent Contingent Workers apply**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:**Regular**Relocation:**No relocation**VISA Sponsorship:**No**Travel Requirements:**No Travel Required**Flexible Work Arrangements:**Not Applicable**Shift:**Not Indicated**Valid Driving License:**No**Hazardous Material(s):**No**Job Posting End Date:**11/20/2026**\\*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.**