Quality Systems Specialist (Pharmatech Industry) (mfd)

NVision Imaging Technologies; Ulm; Hybrid; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

An innovative biotech startup in Ulm, Germany is seeking a Quality Systems Specialist to manage and enhance their Quality Management System. You will coordinate daily operations, implement QMS metrics, and ensure compliance with ongoing quality processes. Candidates should have at least 3 years in quality assurance within GMP environments and excellent problem-solving skills. This company offers a competitive salary and a hybrid working model.

Leistungen

Competitive compensation based on base salary and stock options

Hybrid working model

Key role in a fast-growing startup

30 vacation days

Relocation support

Qualifikationen

• At least 3 years of hands-on experience in quality assurance in a GMP environment.
• Demonstrated experience in the development and continuous improvement of cGMP quality systems.
• Excellent problem-solving, analytical, and communication skills.
• Familiarity with electronic Quality Management Systems (eQMS).
• Fluent in English.

Aufgaben

• Coordinate and manage the daily operation of the QMS in compliance with GxP regulatory and internal standards.
• Implement and manage a system of QMS metrics and measures.
• Serve as the principal point of contact for all QMS-related matters.
• Support the development, implementation, and continuous improvement of the QMS.
• Oversee and coordinate core quality processes including Document & Training Management.

Kenntnisse

Quality Assurance

FDA Regulations

Data Collection

Food Safety Experience

ISO 9001

Mobile Devices

Root Cause Analysis

Quality Systems

OSHA

Food Processing

Quality Management

cGMP

Jobbeschreibung

Your mission

We are searching for a Quality Systems Specialist (m / f / d) to support the establishment and management of an innovative pharmaceutical Quality Management System (QMS).

Reporting to the Senior Director of Quality you will :

• Coordinate and manage the daily operation of the QMS in compliance with GxP regulatory and internal standards.
• Implement and manage a system of QMS metrics and measures
• Serve as the principal point of contact for all QMS-related matters.
• Support the development implementation and continuous improvement of the QMS ensuring alignment with applicable regulations.
• Oversee and coordinate core quality processes including Document & Training Management Supplier & Audit Management Change Controls Deviations CAPAs Self-Inspections Complaints and Risk Management.
• Apply a risk-based approach and maintain the Quality Risk Register.
• Prepare review and maintain quality policies SOPs and related documentation.
• Support the rollout and training of the QMS and the implementation of an eQMS (including system administration).
• Conduct self-inspections and ensure continuous improvement initiatives are embedded.

Support and foster a strong Quality Culture :

Provide cross-functional quality support in the design and implementation of processes as part of the QMS.

• Deliver training and guidance on quality topics.
• Support quality investigations and Quality Management Reviews.
• Represent Quality in projects impacting the QMS.

Your profile

• At least 3 years of hands‑on experience in quality assurance in a GMP environment.
• Demonstrated experience in the development and continuous improvement of cGMP quality systems.
• Excellent problem‑solving analytical and communication skills.
• Familiarity with electronic Quality Management Systems (eQMS).
• Fluent in English.

Why us

• Competitive compensation based on base salary and stock options
• Hybrid working model
• Key role in a highly advanced and fast‑growing startup company
• Ample opportunity for personal initiatives openness to new ideas and room for considerable personal impact
• Impactful product promoting better understanding and treatment of disease
• International team from over 20 different nationalities
• Enjoyable work atmosphere with an open‑door and open communications mentality
• Indefinite employment contract providing stability
• Long‑term career growth opportunities
• 30 vacation days
• Relocation support

Contact information

Join us in making a difference! Submit your application to be considered for this exciting opportunity.

Any questions Please contact :

Sandra Schärli

Senior Talent Acquisition Manager

mail : About us

NVision is a quantum biotech startup based in Ulm Germany with Tier 1 investors from the USA and Europe. We are just leaving stealth mode moving from local R&D to global commercialization and expansion.

We are developing a technology that will enable MRI‑based imaging of real‑time metabolism in the body with tremendous potential for research and applications in oncology cardiology neurology and more. Our company brings together expertise in physics chemistry engineering and medicine and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York MD Anderson in Texas Technical University of Munich Cambridge University in the UK and more.

NVision is developing fast robust and easy‑to‑use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast fully‑automated multi‑step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully‑reuseable or single‑use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in‑house.

We offer a dynamic international working environment with immense room for growth that encourages personal initiative and open communication.

Please note that for data privacy reasons we will not review applications or CVs sent via email. Unsolicited applications can be submitted here .

Required Experience

IC

Key Skills

• Quality Assurance
• FDA Regulations
• Data Collection
• Food Safety Experience
• ISO 9001
• Mobile Devices
• Root cause Analysis
• Quality Systems
• OSHA
• Food Processing
• Quality Management
• cGMP

Employment Type

Full‑Time

Experience

years

Vacancy

1