Senior Manager, Supplier Quality and Quality Management Systems

Overview Senior Manager, Supplier Quality and Quality Management Systems (Remote) CellCarta, a Contract Research Organization, is hiring a Senior Manager, Supplier Quality and Quality Management Systems. This role leads supplier quality systems, regulatory alignment, and continuous improvement to ensure services meet industry standards and support human health objectives. Responsibilities Lead the development and execution of supplier quality strategies, ensuring alignment with corporate quality objectives and regulatory requirements. Oversee supplier performance, risk management, and compliance. Lead comprehensive supplier assessments, including risk evaluations, audits, and qualification questionnaires. Serve as the primary interface with corporate suppliers, fostering strategic partnerships and ensuring alignment with quality expectations. Maintain and negotiate quality agreements reflecting current regulatory and operational requirements. Plan, execute, and oversee supplier audits, ensuring thorough documentation and follow-up. Contribute to the development and implementation of a robust third-party IT vendor management program, ensuring quality and compliance across digital platforms and services. Maintain and enhance systems for managing supplier complaints and Supplier Corrective Action Requests (SCARs), ensuring timely resolution and continuous improvement. Participate in ISO certification audits, including ISO 27001 and ISO 13485. Serve as a subject matter expert on Quality Management Systems. Perform and support QA review of Computer System Validation (CSV) deliverables related to CellCarta systems. Collaborate across CellCarta business units to develop harmonized policies, procedures, and work instructions. Lead initiatives to standardize key quality system SOPs that meet site-specific and corporate requirements. Partner with internal stakeholders to identify and implement process improvements that enhance quality system performance, supplier oversight, and regulatory compliance. Manage and update corporate documents, including corporate supplier management materials, to present in management reviews. Education Minimum BA/BS in science or health-related discipline Main Requirements Minimum of 5 years’ experience managing supplier quality systems. Ideal candidate will have experience in managing supplier quality and performing CSV reviews. Two years of audit experience is preferred. Knowledge of GCLP, GMP, and global regulatory frameworks to ensure supplier quality systems meet evolving compliance standards. Proficiency in ISO 13485, ISO 15189, and CAP/CLIA requirements, serving as a key resource during audits and inspections. Lead supplier quality alignment initiatives, including development and negotiation of quality agreements. Knowledge of compliance requirements for different stages of development and applicable global regulations. Excellent written and verbal communication skills; ability to clearly articulate complex quality requirements and agreements to internal and external stakeholders. Influence cross-functional teams through clarity, credibility, and strategic insight. Strong project management skills. Experience reviewing CSV documentation is preferred. Working Conditions Regular working hours: Monday to Friday, 9:00 AM – 5:00 PM This is a remote position; however, candidates must be located in Canada Benefits Competitive Wages Vacation and Personal Days Comprehensive Group Insurance Plans RRSP Contribution with Employer Matching Employee Annual Incentive Plan (EAIP) Dialogue Telemedicine Service and Employee Assistance Program (EAP) Referral Program Career Advancement Opportunities About CellCarta CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry, supporting the drug development lifecycle from discovery to late-stage clinical trials. The company operates globally with facilities in Canada, USA, Belgium, Australia, and China. Joining CellCarta means working with dedicated professionals focused on achieving our mission of impacting patient therapy. We strive to make a difference in patients’ lives around the world. Notes: The information collected to review your application will be processed by CellCarta’s human resources services in accordance with applicable laws. If you do not want us to retain your information, contact #J-18808-Ljbffr