Compliance Specialist Operations

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Job Function:
Supply Chain Manufacturing
Job Sub Function:
Manufacturing Pharmaceutical Process Operations
Job Category:
Business Enablement/Support
All Job Posting Locations:
Schaffhausen, Switzerland
Job Description:

Compliance Specialist / Teamlead Operations (m/w) - CM&T F2 P2

This role is responsible for implementing and ensuring compliance with new regulatory requirements, supporting other production team leaders in GMP-compliant manufacturing, leading a team that produces clinical products (compounding, filling, visual inspection, and device assembly), and supporting projects within CM&T production.

Responsibilities (summary)

• Support and implement measures to ensure compliance with Annex 1 requirements.
• Lead and schedule a production team in a two-shift operation, with responsibility for target achievement and overall performance.
• Ensure on-time delivery of clinical and commercial batches in coordination with global and local planning.
• Ensure EHS, GMP, and regulatory compliance, including audit readiness.
• Manage and execute NPI and operational projects; support qualification and validation activities.
• Contribute to MES/PAS-X adjustments, M /ESP management, and document maintenance.
• Coach and develop team members and promote continuous improvement (Lean).
• Provide role coverage during absences, deputising for other team leads or department management.

Your profile

• Completed vocational training in the pharmaceutical field or a BSc in Pharmaceutical, Biochemical, Chemical sciences, or equivalent.
• Minimum of 2 years' experience in a GMP environment.
• Production leadership experience in a two-shift operation; project management experience is an advantage.
• Strong problem-solving skills, effective cross-functional collaboration, and clear communication.
• Excellent German and English skills, both written and spoken.
  
  #DPDS

Required Skills:

Preferred Skills:
Agile Manufacturing, Analytics Dashboards, Chemistry, Manufacturing, and Control (CMC), Communication, Data Compilation, Data Savvy, Empowering People, Execution Focus, Gap Analysis, Give Feedback, Good Manufacturing Practices (GMP), Operational Excellence, Plant Operations, Proactive Behavior, Problem Solving, Process Optimization, Project Administration, Resource Allocation, Standard Operating Procedure (SOP)