The Siesta Group is a specialized service provider supporting clinical trials worldwide with innovative tools and expertise in the assessment of sleep, circadian rhythms, and central nervous system function. We combine scientific excellence with advanced software solutions to ensure that data collection, processing, and analysis meet the highest quality and regulatory standards.
We are seeking a Quality Assurance (QA) Manager to lead and strengthen our quality framework across clinical, operational, and software development activities. This role is central in ensuring that our organization not only complies with current regulations but is also prepared for future challenges in digital health and AI.
Become part of our excellent team where there is something new to learn every day!
QA Manager
Tasks
- Quality & Compliance Leadership
- Provide overall QA oversight, ensuring compliance with Good Clinical Practice (GCP) and international regulatory requirements (FDA, EMA, etc.).
- Monitor and interpret regulatory changes, advising management and teams on their impact.
- Act as the main point of contact for quality-related matters with clients, auditors, and regulators.
- Quality Management System (QMS)
- Develop, implement, and maintain a robust QMS that ensures compliance with ICH-GCP guidelines, clinical trial regulations, and software development standards.
- Establish and update SOPs, work instructions, and quality policies in line with ALCOA++ principles.
- Ensure compliance of software development processes with IEC 62304, 21 CFR Part 11, and related computerized system validation requirements.
- Anticipate and integrate requirements from emerging AI regulations into the company's quality framework.
- Work closely with IT and software engineering teams to embed compliance into system design, data workflows, and validation activities.
- Audits, Inspections & Vendor Qualification
- Lead preparation for and management of external audits and inspections by regulatory bodies and clients.
- Conduct internal audits to assess compliance and ensure inspection readiness.
- Coordinate and complete vendor qualification questionnaires and quality-related sections of RFPs.
- Manage follow-up activities, including CAPAs, and ensure timely resolution of findings.
- Training & Quality Culture
- Provide training on GCP, SOPs, software compliance standards, and regulatory requirements.
- Develop refresher programs to ensure ongoing staff awareness of new regulations and best practices.
- Promote a strong quality culture across clinical, operational, and technical teams.
- Risk Management & Continuous Improvement
- Identify and assess potential risks in clinical and software processes.
- Implement effective risk mitigation strategies.
- Use audit outcomes and performance indicators to drive continuous improvement.
- Lead corrective and preventive actions (CAPA) to strengthen compliance and efficiency.
Requirements
Your Profile
- Degree in life sciences, pharmacy, engineering, or related discipline.
- Strong QA experience in clinical trials, ideally within a CRO, pharma, or biotech setting.
- Familiarity with software development quality standards (IEC 62304, 21 CFR Part 11, ALCOA++).
- Knowledge of regulatory frameworks related to AI in clinical research is an advantage.
- Excellent organizational, analytical, and communication skills.
- Ability to work cross-functionally and engage with both scientific and technical teams.
Offer
- A strategic role at the intersection of clinical research and technology innovation.
- The opportunity to shape our quality and compliance strategy in both clinical trials and software/AI development.
- Collaboration with leading pharmaceutical companies and exposure to international regulatory standards.
- A flexible and dynamic working environment within a growing company.
- Full remote work possible
- Lots of creative freedom
- Flat hierarchies
- Individual support for your further training
- Partial reimbursement for the Klima Ticket and Jahreskarte
If this job description sparked your interest and if you find your profile matching the profile we are looking for, please contact us.
We are very much looking forward meeting you in a virtual meeting and talking to you about our company, our team of developers, and the future perspectives we envision.
Salary
The actual salary depends on your qualifications and experience and is between 44,450 EUR und 54,600 EUR gross per year (on a 38.5-hour basis). The salary is paid 14 times per year.
About this job
Employment type
Full Time (Permanent employment)
Salary
44,450 EUR to 54,600 EUR yearly
Seniority level
Professional Experience
Work model
Hybrid
Place of work
Wien
Field of work
IT, Data Processing, Engineering, Technical Jobs, Science, Research
Unfilled vacancies
1 vacancy unfilled for this position
About the company
Employer
The Siesta Group Schlafanalyse GmbH
Number of employees
11 - 30 employees
Locations
Wien
Details about this job
Full Time (Permanent employment)
- 38,5 hours
Place of work
- Wien
Required languages
- English B2
- German C1
Nice-to-have languages
- French B1
All infos regarding your application
Reference number:
QAM2025_09
Required application documents:
- Résumé
- Cover letter
Contact person
Charlène Rahmoune
Human Resources Manager