Overview
Quality Assurance Manager Jobs in Berne, Switzerland at GxPeople Global
Title: Quality Assurance Manager
Company: GxPeople Global
Location: Berne, Switzerland
GCP QA Manager
This is an exciting and strategic opportunity for a Quality Assurance professional to play a key role in clinical studies within a highly regulated environment. This position offers fantastic growth and development opportunities for the right candidate. You will be part of a dynamic team, driving quality initiatives, supporting Good Clinical Practice (GCP) compliance, and contributing to change management as the organisation adapts to evolving regulatory expectations.
Key Responsibilities:
Support GCP compliance and maintain quality standards in clinical studies.
Drive quality initiatives and lead change management efforts as the company adapts to regulatory developments (e.g., ICH E6 R3).
Maintain and improve the Quality Management System (QMS) in a GCP context.
Lead audits (site, internal, third-party) with a focus on maintaining inspection readiness and documentation.
Provide back-room support for inspections, with the potential to transition into front-room hosting.
Ensure clinical studies oversight, managing QA functions for outsourced clinical trials.
Manage regulatory trends, guiding the organisation proactively to meet emerging requirements.
Key Requirements:
Experience in Clinical Quality Assurance, with ideally 10+ years of combined experience in QA and Clinical Operations.
Strong experience with ICH E6 GCP, including knowledge of Revision 2 and awareness of Revision 3.
Strategic mindset with the ability to anticipate regulatory trends and guide the organisation.
Change management experience, capable of embedding new processes, reassuring stakeholders, and driving adoption without disruption.
Experience maintaining and improving QMS in a GCP environment.
Familiarity with Good Vigilance Practice (GVP) and Pharmacovigilance (PV) systems.
Proven experience leading audits (site, internal, third-party).
Strong documentation and inspection readiness skills.
Experience working with clinical trials oversight as a sponsor.
Knowledge of medical device regulations is an advantage.
‼️All candidates must be eligible to live and work in Europe‼️
