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Merck is seeking a Specialist in Planning & Scheduling within Global Clinical Supply to support GxP Quality System activities, ensuring compliant, inspection-ready clinical supply operations across phases I–IV in a fast-paced matrix environment.
The role emphasizes deviations, CAPA, and data integrity, with opportunities to grow in change control, documentation, training, audits, and risk management under established governance.
The 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.
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.
With developing subject matter expertise, strong execution focus, and the ability to follow defined processes and procedures, candidates must demonstrate:
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.
Adaptability, Analytical Thinking, CAPA Investigations, Conducting Investigations, Cross‑Functional Communications, Data Analysis, Driving Continuous Improvement
MRP Systems, Six Sigma
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.