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.

Additional location(s) Compensation Information:

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.