Return to search results

GMP Compliance Specialist - Quality Control

LocationFenil-sur-Corsier, Switzerland
Business SectorBiotechnology
Contact email
Job ref26306
Published12 minutes ago
GxP Compliance Specialist – Quality Control
Fenil-sur-Corsier, Switzerland – 6-Month Contract (with the possibility of extension)

Job Description
As a GxP Compliance Specialist – Quality Control, you will join the Global Analytical Development, Analytical Operations & QC organization in Fenil-sur-Corsier, Switzerland.

In this role, you will serve as the QC compliance expert, supporting daily laboratory operations, ensuring adherence to GxP and data integrity standards, and driving continuous improvement across quality systems. You will collaborate closely with QC, QA, and cross-functional stakeholders to maintain inspection readiness, manage deviations, and uphold robust documentation and training frameworks.

Key Responsibilities
Quality & Compliance Support (QC Operations)
  • Support QC teams in daily operations as the compliance subject matter expert.
  • Manage, investigate, and close deviations, non-conformances, events, and related quality records in collaboration with SMEs.
  • Contribute to data reviews ensuring compliance with established quality requirements and GxP expectations.
  • Perform periodic reviews and ensure timely progression of deviations, change controls, CAPAs, and investigations.
  • Maintain and improve the data integrity knowledge base, including DI risk assessments, action plans, and routine reporting to leadership.

Documentation & Regulatory Alignment
  • Author, review, approve, and maintain relevant SOPs, Work Instructions, and quality documentation.
  • Contribute to the evaluation of regulatory/pharmacopoeia updates relevant to QC processes.
  • Support audit preparation and directly interact with internal auditors and external regulatory agencies.
  • Recommend and implement system, process, and procedural improvements within QC compliance activities.

Training, Cross-Functional Collaboration & Continuous Improvement
  • Manage QC team training plans and ensure training compliance.
  • Serve as the key liaison with QA to resolve compliance issues and drive corrective actions.
  • Provide training and guidance to staff on GxP, data integrity, and quality best practices.
  • Stay up to date on regulatory changes, industry trends, and compliance expectations to ensure continuous improvement and operational readiness.

Essential Skills
  • 5–10 years of experience in QC, analytical development, or quality/compliance roles within biotech, pharma, or other regulated GxP environments.
  • Strong understanding of GLP/GMP and Quality System requirements (ICH, FDA, EMA).
  • Hands-on experience with deviations, CAPAs, change control, and quality documentation.
  • Solid investigational and problem-solving skills; ability to interpret complex situations and recommend effective solutions.
  • Prior experience supporting audits and interactions with health authorities.
  • Knowledge of data generation, data processing, and data quality principles.
  • English fluency (B2+ required); French is an advantage.

Preferred Experience
  • Practical experience working in a QC laboratory setting.
  • Familiarity with laboratory information systems (LIMS), digital QC tools, automation technologies, and lean methodologies.
  • Experience driving or supporting data integrity programs.

Soft Skills
  • Highly motivated, autonomous, and adaptable; able to manage multiple priorities in a dynamic environment.
  • Strong interpersonal and communication skills with the ability to collaborate effectively across teams.
  • Proactive mindset focused on delivering results and driving continuous improvement.

Additional Insights
  • Start Date: ASAP
  • Contract Duration: 6 months (with the possibility of extension)
  • Location: Fenil-sur-Corsier, Switzerland
     
Interested?
Send your CV to Khanyi Mabena at k.mabena@panda-int.com, or contact directly at +41 44 551 44 07 to learn more.