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 F2P2

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, MBR/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 Co...