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.
- 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
CellCarta is 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, “C
Skills Required
- Bachelor's degree in a scientific discipline or equivalent experience
- At least 3 years of Quality Assurance experience in a regulated environment
- Experience in biotechnology, pharmaceutical, CRO, medical laboratory, or medical device industries
- Exposure to GCP, GCLP, CAP/CLIA, ISO 15189, ISO 13485, and applicable regulatory requirements
- Strong written and verbal English communication skills
- Strong analytical thinking, attention to detail, prioritization, deadline management, risk-based thinking, initiative, and accountability
- Ability to work a hybrid schedule with at least three days onsite per week
What We Do
Caprion Biosciences was a leading provider of proteomics and immune monitoring services to the pharmaceutical and biotechnology industry, specializing in advanced immunology and proteomics services. It has since rebranded to CellCarta, a global contract research organization.
