We are seeking a Quality Operations Associate to serve as the primary interface between Opterion, Contract Development and Manufacturing Organizations (CDMOs), and external vendors to ensure consistent GMP-compliant and release of manufactured batches. The role ensures batch compliance by coordinating quality activities across internal stakeholders and external vendors, including oversight of batch documentation (e.g., batch records, deviations, investigations, and CAPAs) and ensuring timely, complete, and inspection-ready quality records.

This position is also responsible for managing Opterion’s electronic document management systems (eDMS), including user access, training support, document control workflows, and change management within the system. The Associate ensures the eDMS remains in a validated state through controlled updates, periodic reviews, and maintenance of validation documentation, working with IT and system vendors as needed. This position reports into the Head of Quality.

**Workload:**
80% - 100%, onsite

**Eligibility:**
Applicants must hold a valid Swiss work permit or otherwise be legally authorized to work in Switzerland. Fluency in spoken and written English is required.

**Key Responsibilities**

**Electronic Quality Systems**

- Oversee and continuously administer the eDMS, providing support and training to subject matter experts (SMEs).
- Ensure timely and accurate filing of technical and quality documentation in both the eDMS and shared folders.
- Configure and maintain the eDMS, ensuring its validation in accordance with current validation requirements.
- Support the validation of tools and computerized systems, maintaining validation documentation.
- Implement, train, and manage the electronic Quality Management System (eQMS), including modules for Deviations, CAPAs, Training, and more.

**Operations and Quality Events**

- Facilitate and support the reporting of internal deviations, change controls, complaints, and other quality events related to pre-clinical and clinical activities.
- Review and manage external deviations, change controls, out-of-specification (OOS) results, non-conformances, CAPAs, and their related investigations from manufacturers of drug substances and drug products.
- Support the review of executed batch records as well as sponsor batch disposition.
- Manage and support the timely and effective resolution of internal and external deviations, non-conformances, investigations, change controls, complaints, and CAPAs. Periodically analyze trends and report on status and progress.

**Continuous Improvement and Training**

- Promote best practices in data integrity by training and supporting employees and SMEs on practical application (ALCOA+), reinforcing good documentation habits, and periodically reporting on adoption and progress.
- Draft, review, approve, and maintain SOPs, Work Instructions, and all other quality documents within the eDMS. Organize and coordinate relevant training sessions.

**Vendor/Supplier Qualification and Operations**

- Support the qualification process for GxP vendors and suppliers, including audit planning, preparation of audit agendas, and CAPA follow-up. Maintain the list of qualified GxP vendors and suppliers.
- Perform GMP/GDP audits

**Skills and Competencies**

- Bachelor’s degree in pharmacy, chemistry, chemical engineering, biological sciences, or related discipline.
- Over three years of hands-on quality experience in the biotechnology or pharmaceutical industry, ideally with sterile products.
- Proven experience in computerized systems validation.
- Practical experience managing deviations, OOS results, and related investigations/CAPAs from manufacturers and testing laboratories.
- Experience in establishing quality SOPs and supporting clinical and CMC staff in developing operational SOPs and delivering training.
- In-depth knowledge of GMP and ICH regulatory requirements.
- Fluency in spoken and written English. Other languages (German, French) a plus.
- Strong analytical mindset and attention to detail.
- Collaborative management skills.

**Why Join Us:**

**Our Vision is:**
Revolutionizing dialysis care to set a new standard of care in peritoneal dialysis.

**Our Mission is:**
To relentlessly innovate for those living with chronic kidney disease, creating breakthrough therapies that put patients first. We are driven by science, guided by compassion, curiosity, and the belief that every person deserves in a future free from the burdens of outdated treatments.

**You will:**

• Work at the interface of science and clinical development, driving impact on real-world therapies.

• Collaborate in a cross-functional, international environment that values scientific excellence and teamwork.

• Receive competitive compensation, professional development opportunities, and a culture focused on integrity and innovation.