Overview
Join to apply for the Senior QMS Analyst role at Indivi.
This position is based in Basel, Switzerland and can be offered on a full-time or part-time basis (80–100%). Applicants must hold a valid permit to work in Switzerland.
Indivi is a TechBio company enabling precision and personalised medicine in neuroscience research and development. We are growing and looking for team members who want to contribute to making our vision — making measurable what is not so — a reality.
We are an equal opportunities employer and encourage applications from candidates of all backgrounds, particularly from underrepresented groups. Reasonable adjustments will be made wherever possible.
Your role
As a Senior QMS Analyst, you will be responsible for the implementation and maintenance of the Quality Management System (QMS) for software used in a regulated pharmaceutical trial environment or as a medical device. You will ensure product compliance and internal quality standards align with global regulatory requirements and client expectations.
Key Responsibilities
* Act as the primary point of contact for the implementation and maintenance of the QMS as per ISO 13485 (or other relevant standards), focusing on core QMS processes including:
* CAPA and Nonconformance
* Complaints
* Change Management
* Document and Record Management
* Audit
* Supplier management
* Management Review
* Develop and maintain essential quality documents (procedures, work instructions, SOPs)
* Ensure deviations are addressed appropriately
* Coordinate and represent the QMS during external audits, vendor qualification, and regulatory inspections
* Support Head of RA/QM with Quality Planning, Quality Objectives, and Quality Manual
* Conduct internal audits and maintain supplier controls
* Collaborate with ISMS manager to integrate core processes in a unified QMS
* Manage and coordinate the use of software tools and systems that support QMS best practices
Necessary Competence
* Bachelor’s degree or higher in a relevant area
* Certified internal auditor
* GCP Basic understanding
Needed skills
* Ability to explain complex material in understandable language
* More than 5 years experience in a highly regulated environment
* More than 3 years in a QMS role
* Experience with performing internal audits
* Previous experience with ISO 13485
* Good understanding of Pharma GMP (preferred)
* Pragmatic problem solving skills and drives continuous improvement
* Eye for detail
* Excellent writing skills and ability to transform text into graphical instructions
Language
A high level of English proficiency is mandatory. Fluency in additional languages, especially Spanish, is highly valued.
Recruitment Process
We are currently collecting applications; CV review will begin in mid-October, and interviews are expected later in the month.
About Us
Indivi is an equal opportunities employer that focuses on improving the lives of people with neurological disease.
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