Quality Manager – Product Development

As a global Research Organization in the biopharmaceutical industry, CellCarta (formerly Caprion – HistoGeneX) provides access to a broad offering of biomarker platforms and services. We partner with our clients to address the most complex scientific testing needs, delivering customized biomarker testing solutions to further the limitless potential of precision medicine.

We offer our services on a global scale through our laboratories in the USA, Canada, Belgium, China and Australia.  Combining expertise in histopathology, immune monitoring, proteomics, genomics and sample logistics, we support pharmaceutical and biotechnology companies in the research and development of innovative new medicines for the treatment of cancer and immune diseases. Working under stringent quality and regulatory requirements, we strive to make a difference in the future treatment options offered to patients.

CellCarta leverages its strong expertise in cancer to support the entire spectrum of biomarker services including biomarker discovery in the research phase, tumor profiling and biomarker monitoring in clinical studies and companion diagnostics registration studies, patient diagnostics and development of new techniques and tests for tumor analysis and prediction of treatment response. The company bridges the gap between research, clinical studies and diagnostics.

We are currently recruiting a  Quality Manager – Product Development

Based in

Wilrijk (Belgium) is the preferred location, but Ghent (Belgium) or Naperville (US) is also possible

Introduction to the job

• The Quality Manager – Product Development plays a key role throughout the development of assays and software for use in clinical studies, and/or for approval as a Companion Diagnostic (CDx).

• The Quality Manager – Product Development works in close collaboration with an international cross-functional team, and scientific and operational experts from different business areas such as immunology, histopathology, proteomics, genomics, as well as digital pathology and AI.

Major responsibilities

The Quality Manager  – Product Development is responsible to

• Set up, maintain and improve the product development and risk management processes at CellCarta for the development of clinical trial assays, IVDs and software under ISO 13485, and in compliance with IVDR and 21 CFR part 820

• Review and approve product development deliverables, as applicable, and ensure appropriate quality requirements are defined and conveyed throughout the product development process

• Ensure product FMEA’s are performed as required to mitigate risks in design, transfer, and manufacturing

• Participate actively in product development project team meetings, present Quality updates, follow up on actions and escalate issues when appropriate

• Support development, implementation and maintenance of Design Verification & Validation (V&V) methodologies and best practices globally

• Support DMR and DHF compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained

• Assure customer needs are met, and patient samples are tested with high-quality products

• Collaborate with regulatory team in the development of regulatory submissions

• Advise, consult, coach, and lead product change requests, root cause investigations, process improvements and implement a “culture of quality”

• Provide support to complaint handling and post-market surveillance

• Analyze quality metrics and investigate adverse trends to identify variables that may potentially affect product and processes, and present to management

• Host internal and external audits

• Organize training on design control, validation and risk management

Profile

The Quality Manager – Product Development has a minimum of a bachelor’s degree (preferably Biology, Biomedical Sciences, Bioengineering, Pharmaceutical Sciences, Biochemistry) with a minimum of 3 years of experience in a quality assurance or regulatory role, preferably in a function supporting new product introductions.

Job-Related competences

Experience related to ISO 13485, IVDR and 21 CFR part 820, as well as GCP, GCLP, ISO 15189, CAP and CLIA requirements is a plus.

Personal competences

• Excellent communication skills (internal and external stakeholder management)

• Capacity to react to and cope with unexpected situations and changing priorities

• Dynamic personality, a true team player with good interpersonal skills

• Excellent organizational skills

• Analytical thinker with a process-oriented mindset

• Good documentation skills (accurate, attention to detail)

• Advanced knowledge, orally and in writing of English, knowledge of Dutch and French is a plus

• Willingness to travel  

We offer an exciting and challenging full-time position in a multinational environment where customer focus and innovation are key business values. You will join a global CRO where your expertise matters, your contributions will have an impact and significant opportunity to advance your career. You will receive thorough on-the-job training.

Send your resume and application letter to hgx_people@cellcarta.com