Senior Clinical QA Manager

Idorsia Pharmaceuticals

Basel, Switzerland

Job Responsibilities

We are seeking a highly skilled and motivated Senior CQA Manager to join our QA Compliance & Auditing Team. In this role, the Senior CQA Manager will provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs. You will be responsible for quality oversight, process improvements, inspections, audits, and training across all phases of clinical development.

Key Quality Assurance partner for clinical trial teams, providing expert guidance throughout study planning, execution, and closure;
Ensure clinical trial activities comply with regulatory requirements and Good Clinical Practice (GCP);
Collaborate closely with internal teams and CROs to support high‑quality trial conduct and resolve quality‑related questions;
Identify risks, propose pragmatic solutions, and escalate significant quality issues when needed;
Develop and deliver training on GCP and clinical quality topics to internal/external stakeholders;
Support continuous improvement by contributing to the development and optimization of quality processes, tools, and clinical systems;
Lead the preparation, coordination, and follow‑up activities related to health authority inspections;
Conduct a variety of audits (e.g., sites, vendors, processes) and oversee related corrective actions;
Represent the QA Compliance & Auditing GCP function in internal and external meetings or professional networks when required;
Collaborate across the organization and contribute to maintaining high-quality standards and enable delivery of reliable clinical data.

Candidate's Requirements

Strong background in Good Clinical Practices and holds a master’s degree in a relevant scientific discipline (Pharmacy or other scientific or health related fields), additional knowledge in Quality Assurance/Compliance and Auditing.

Minimum 6 years of industry or health authority experience, including ≥4 years in GCP Quality Assurance;
Strong experience in Clinical Research & Development;
Excellent understanding of ICH-GCP and clinical trial regulatory requirements;
Experience with clinical electronic systems (eTMF, ePRO, eSource, etc.);
Experience in international and cross‑cultural environments;
Excellent written, verbal, and listening communication skills;
Excellent at problem solving and ability to measure and manage risk(s);
Effective negotiation and influencing capabilities;
Reliable, conscientious, and adaptable;
Ability to work independently and collaboratively in a matrixed environment;
Ability to travel at least 25%;
Languages: fluent in English.