Spclst, Planning & Scheduling

Job Description

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. 

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.  

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