Senior Compliance Specialist | Senior Compliance Specialist | M/W/D - Referenz 001158

consult16 GmbH

Biberach an der Riß, Baden-Württemberg, Deutschland
Published Apr 27, 2026
Full-time
Fixed-term

Job Summary

As a Senior Compliance Specialist, you will play a pivotal role in the GMP-related qualification of disposables and packaging materials for a leading international pharmaceutical company. Your day-to-day responsibilities include managing complex cross-functional change control processes, drafting and revising GMP documentation such as specifications and SOPs, and overseeing the lifecycle management of materials. You will act as a key interface between Supply Chain, Quality Assurance, and Production. Additionally, you will handle deviations, investigations, and CAPAs, while supporting the preparation for audits and inspections. This role requires a strong regulatory mindset and the ability to drive quality events to completion under strict timelines. The position offers a hybrid work model, allowing for remote flexibility while requiring on-site presence in Biberach for critical meetings and initial onboarding. This is an excellent opportunity for a seasoned professional to apply their pharmaceutical expertise in a dynamic, project-driven environment.

Required Skills

Education

Completed Diploma or Master's degree in Pharmacy, Chemistry, Biotechnology, or a comparable field.

Experience

  • Professional experience in pharmaceutical quality control
  • Demonstrated experience in the assessment, monitoring, and implementation of GMP requirements
  • Experience in managing regulatory requirements for disposables and packaging materials
  • Proven track record in handling deviations, investigations, and CAPA processes
  • Experience in cross-functional collaboration and stakeholder management within a production environment

Languages

English (Fluent)

Additional

  • Work location is Biberach; hybrid model with required on-site presence for meetings and onboarding. No travel or accommodation expenses covered by the employer. Fixed-term contract until June 30, 2027, via temporary employment (ANÜ).