Quality Assurance Manager

caprion; Antwerpen; Hybride; EUR 70 000 - 110 000; Plein temps

Résumé du poste

CellCarta seeks a Quality Assurance Manager to lead client audits and regulatory inspections, ensuring QMS compliance and cross-functional collaboration. The role involves hosting audits, responding to inquiries, and driving CAPA-based improvements across the organization.

The successful candidate will review documents, approve quality events, deviations and CAPAs, and support change controls, internal audits, supplier oversight, and continuous improvement initiatives within a hybrid, full-time

Qualifications

• Minimum 3 years of QA experience in a regulated environment with exposure to GCP, GCLP, CAP/CLIA, ISO 15189, ISO 13485.
• Attention to detail and strong written and spoken English.
• Good communication, analytical thinking, and ability to prioritize work.

Responsabilités

• Lead client audits and regulatory inspections, including prep, hosting, coordination, response management and follow-up.
• Present and explain the QMS and key processes to auditors and inspectors.
• Coordinate investigations, root cause analysis, CAPA development, and timely resolution of findings.
• Review and approve controlled documents, records, events, deviations, investigations and CAPAs.
• Support change control activities and training, internal audits, supplier oversight, and risk management.

Connaissances

GXP knowledge

English proficiency

Regulatory audits

Quality metrics

Formation

Bachelor's degree in a scientific discipline

Outils

QMS software

CAPA tracking

Description du poste

Quality Assurance Manager

Summary

This role is an individual contributor position within a global quality organization and has no direct reports. The position requires effective collaboration with cross-functional teams to support compliance and quality objectives.

Responsibilities

Client Audits & Regulatory Inspections

• Lead client audits and regulatory inspections, including preparation, hosting, coordination, response management and follow-up activities.
• Present and explain the Quality Management System (QMS) and key operational processes
• Coordinate and provide responses to auditor and inspector inquiries in collaboration with subject matter experts
• Coordinate the investigation, root cause analysis, CAPA development and timely resolution of audit findings.

Quality System Oversight & Documentation

• Review and approve controlled documents and records, to ensure accuracy, completeness and compliance with internal procedures and regulatory requirements
• Review and approve quality events, deviations, complaints, investigations and CAPAs.
• Facilitate, review and approve change control activities
• Support Quality Management System processes, quality processes training, internal audits, supplier qualification and oversight, computerized system validation, equipment lifecycle management, quality metrics, risk management and continuous improvement initiatives.

Education

• Bachelor’s degree in a scientific discipline, or equivalent by experience

Main Requirements

• Minimum 3 years of Quality Assurance experience in a regulated environment, preferably within the biotechnology, pharmaceutical, CRO, medical laboratory or medical device industry, with exposure to GCP, GCLP, CAP/CLIA, ISO 15189, ISO 13485, and applicable regulatory requirements.
• Attention to detail
• Good knowledge, orally and written of English
• Good communication skills (verbal and written)
• Good analytical thinking skills
• Able to establish work priorities and meet deadlines
• Applies risk-based thinking
• Professional and positive attitude, take initiative and act accountable

Working Conditions

• Full-time position with a hybrid work schedule requiring a minimum of three days onsite per week.

About CellCarta

CellCartais a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The Company operates globally with facilities located in Canada, USA, Belgium, Australia, and China.
Joining CellCarta means working with dedicated professionals who are focused on achieving our mission of impacting the future of patient therapy. We make a difference in the lives of patients around the world!

Join us as we make an impact on patient therapy!

The information collected to review your application will be processed by the human resources services of CellCarta Biosciences Inc. and its affiliates (collectively, “CellCarta”). The legal basis for this processing is the legitimate interest of CellCarta to evaluate the suitability of candidates for the roles available at CellCarta.

CellCarta will only process that information which is necessary to evaluate your application. This information includes identifying information such as your name, address, email address and phone number, as well as information about your education and professional experience, including previous positions and your CV. Such information is required for us to complete your applicant file, assess your suitability for the role and comply with applicable laws. CellCarta may obtain personal information from other sources, such as during reference, background, or employment checks, with your permission, and from third party sources such as recruitment and assessment sites or professional social media sites, in each case only if such information is relevant to reviewing your application. Your personal information will be retained only for so long as reasonably necessary and in accordance with applicable laws. This information will be processed confidentially and only accessed by those who have a need for the recruitment process. Please note that the information comprising your applicant file may be processed in a country that is not where you are located (for example, you might be in the European Economic Area or Québec, Canada, whereas your applicant file may be reviewed by CellCarta in the United States). If you are offered and accept employment with CellCarta Biosciences Inc. or one of its affiliates, the information collected will become part of your employment record. If you do not want us to retain your information, or want us to update it, please contact [e-mail].