Quality Assurance Manager

CellCarta; Antwerpen; Hybride; EUR 70 000 - 100 000; Plein temps

Avantages offerts par ce poste

Hybrid work schedule

Résumé du poste

CellCarta, located in Antwerp, seeks a Quality Assurance Manager to ensure compliance with QMS across global operations. You will lead client audits, coordinate regulatory inspections, and drive CAPA investigations within cross-functional teams.

The role emphasizes QMS documentation, change control, and continuous improvement. Requires a bachelor’s degree in science and at least 3 years in a regulated QA environment, with a hybrid work arrangement (minimum three onsite days per week).

Qualifications

• Minimum 3 years of Quality Assurance experience in a regulated environment.
• Experience with GCP, GCLP, CAP/CLIA, ISO 15189, ISO 13485, and applicable regulatory requirements.
• Excellent written and spoken English.
• Attention to detail and strong communication skills.

Responsabilités

• 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 inquiries with subject matter experts.
• Coordinate investigations, root cause analysis, CAPA development and timely resolution of audit findings.
• Review and approve controlled documents and records to ensure accuracy and compliance.

Connaissances

Attention to detail

Good communication skills

Strong analytical thinking

English proficiency

Risk-based thinking

Ability to set priorities

Formation

Bachelor’s degree in a scientific discipline

Description du poste

Quality Assurance Manager

The Quality Assurance Manager is responsible for performing quality assurance activities as defined in the quality management system, ensuring compliance with applicable standards and regulations.

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].