Quality/Operations

Signatur Biosciences Ltd; Luik; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Competitive base salary

4 weeks + 12 compensatory days

Private medical insurance (DKV)

Résumé du poste

Signatur Biosciences Ltd is building a laboratory operations team in Liège, Belgium, to support ISO13485 compliant diagnostics development. The Quality & Operations Officer will produce and maintain essential documentation, support QMS processes, and help manage equipment, suppliers, and CSV-related activities.

The role emphasizes cross-functional collaboration across Manufacturing, R&D and Operations, with a focus on high-quality, compliant lab operations in a startup environment.

Qualifications

• Bachelor’s or Master’s degree in Biological Sciences, Molecular Biology, Biotechnology, Biochemistry or related field.
• 3–5 years in biotech/diagnostics IVD QC/QA environments preferred.
• Strong documentation and writing skills with attention to detail.

Responsabilités

• Write, review and maintain SOPs, Work Instructions and QMS documents per ISO13485/IVDR.
• Support QMS activities: change control, document lifecycle, SOP reviews, CAPA documentation.
• Coordinate equipment qualification documentation and supplier management.
• Assist with CSV activities and validation documentation.
• Ensure traceability, data integrity and compliance across lab processes.

Connaissances

Quality management

Documentation

CSV

QMS

GxP

Formation

Bachelor's/Master's in Biological Sciences or related

Master's in Molecular Biology or Biotechnology

Outils

ISO13485

IVDR

QMS software

Description du poste

Today, precision medicine coupled with advanced diagnostics is taking over. However, those innovations in medicine come with an ever-increasing price tag driven by more expensive and complicated solutions making them less accessible unless we do something about it.

Signatur Biosciences was established with the mission of making cutting-edge diagnostic tools accessible to more patients around the world. As a startup we have developed a technology to profile complex molecular signatures in a single reaction using qPCR machines already in place in every biomedical lab around the world. Signatur Biosciences is a startup with a remote workforce, predominantly in London, UK, and is establishing a new laboratory facility in Liège, Belgium.

We're worried about accessibility in precision diagnostics and are building a team of individuals who share our passion for solving this problem through close collaboration and a sense of urgency. We're building a different kind of company, where employees think like owners, act with authority, and collaborate closely with one another.

We are seeking a highly motivated and driven Quality & Operations Officer to join our team. In this role, under the direction of the Head of Laboratory Operations and working closely with the RA/QA Lead, you will be responsible for supporting laboratory operations and quality activities across documentation, processes and systems. You will join Signatur Biosciences at an exciting time as we are a small start-up company looking to grow. You will be part of an expanding laboratory operations team but also interact with colleagues across the company who have the shared mission to make precision diagnostics more accessible. If you are a highly motivated and driven self-starter with a passion for novel diagnostics development, we'd love to speak with you!

About the role:
As a Quality & Operations Officer, you will play a key role in supporting the laboratory and quality processes that underpin the development and manufacturing of our qPCR-based diagnostic kits. You will be responsible for producing high-quality documentation (SOPs, WIs, forms), supporting QMS processes, coordinating equipment management, managing suppliers and consumables, assisting with experimental planning, and contributing to Computer System Validation (CSV) activities.

This role is highly cross-functional and requires strong organizational skills, attention to detail, and the ability to work collaboratively across Manufacturing, R&D, and Operations activities. Your work will directly contribute to maintaining a compliant, efficient, and well-documented laboratory environment aligned with ISO13485 requirements.

Skills, Experience & Attributes

Bachelor’s degree with substantial experience, or Master’s degree in Biological Sciences, Molecular Biology, Biotechnology, Biochemistry or related fields.

Preferred 3–5 years of experience in biotech, diagnostics, IVD manufacturing, QC or QA environments.

Strong understanding of laboratory operations and documentation practices.

Experience working within a Quality Management System for In Vitro Diagnostic development (ISO13485) or equivalent

Excellent writing, organisation and documentation skills.

Strong attention to detail and ability to manage multiple tasks in parallel.

Interest or initial experience in CSV / validation of digital systems, or willingness to be trained.

Experience in a start-up or fast-paced biotech environment.

Previous involvement in equipment management, qualification or maintenance documentation.

Experience with supplier management or laboratory stock management.

Familiarity with qPCR workflows or molecular biology laboratory environments.

Experience in QA/QC or process validation.

Experience with ALCOA+, data integrity, or CSV is a plus.

Main Responsibilities:

Quality & Documentation Management

Write, review and maintain documentation including SOPs (manufacturing, laboratory processes, equipment), Work Instructions, Forms and related QMS documents in accordance with In Vitro Diagnostic development Frameworks (ISO13485 and IVDR)

Support QMS activities such as change control, document lifecycle, periodic SOP review, and CAPA-related documentation.

Review laboratory-generated documentation for completeness, traceability, data integrity and compliance.

Contribute to maintaining high-quality standards across all processes aligned with ISO13485 and IVD development requirements.

Laboratory and Operational support

Support equipment qualification activities by drafting IQ/OQ/PQ protocols and associated SOPs in collaboration with the Head of Laboratory Operations.

Coordinate equipment maintenance schedules, documentation and service interactions.

Support the Head of Laboratory Operations in the implementation and monitoring of metrics (Key Performance Indicators) of laboratory efficiency & effectiveness

Contribute towards the continuous improvement and operations of Signatur Biosciences

Training and coaching of laboratory team members

Manage supplier contacts, request quotations, support ordering processes and oversee delivery and reception of laboratory materials in collaboration with the Head of Laboratory Operations.

Support consumable and reagent stock management to ensure operational continuity.

Draft experimental Forms based on high-level development protocols provided by Scientists and R&D leadership.

Ensure clear and structured documentation enabling laboratory execution.

Computer System Validation (CSV) Support

Contribute to CSV activities associated with the introduction or update of laboratory and quality systems (e.g., QMS tools, data management systems, equipment software).

Support the drafting and review of validation documentation.

Collaborate with RAQA Lead and system owners to ensure validated systems are maintained in a compliant state

Planning and Problem Solving

Sense of Urgency and Focus

Attention to detail & continuous learning

Compensation and Benefits at Signatur Biosciences include:

Competitive base salary (compensation will be based on experience level with requested qualifications).

Paid time off policy that includes: 4 weeks and 12 compensatory days.

Private medical insurance (DKV)

As we continue to grow, our benefits package may evolve. The benefits outlined above are accurate as of the job posting date, but may differ at time of hire.

Further information

Signatur Biosciences is an equal-opportunity employer promoting diversity and inclusion in the workspace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical conditions, veteran status, sexual orientation, gender (including gender identity and gender expression), sex (which includes pregnancy, childbirth, and breastfeeding), genetic information, taking or requesting statutorily protected leave, or any other basis protected by law.