Senior Clinical QA Manager - #44080

About Idorsia Pharmaceuticals Ltd

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.

We are looking for a Senior Clinical QA Manager to join our team !

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
  
  

Work Location: Basel Area

Country: Switzerland

Business Area: Quality Assurance

Schedule: Fulltime

Job Type: Permanent

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.

We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.

We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship.

Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.