Senior Manager, Supplier Quality and Quality Management Systems (Remote)

Senior Manager, Supplier Quality and Quality Management Systems (Remote)

Are you looking to make your next career move? CellCarta, a Contract Research Organization, is hiring a Senior Manager, Supplier Quality and Quality Management Systems to join our dynamic team. In this role, you will have the opportunity to use your expertise and skills to ensure our services meet the highest industry standards. Join a team of talented individuals committed to making a positive impact on human health and well-being. Apply today and take the first step toward an exciting new career with CellCarta!

Summary

The Senior Manager of Quality Systems and Supplier Quality plays a critical leadership role in driving excellence and ensuring robust supplier quality systems that align with regulatory expectations and business objectives. This position is responsible for the strategic oversight, implementation, and continuous improvement of supplier quality processes and system frameworks.

Responsibilities

More specifically, you will participate in the following:

• 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, ensuring they reflect 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 both 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 specific 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;
• Demonstrate 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 the development and negotiation of quality agreements;
• Knowledge of compliance requirements for different stages of development; must have knowledge of applicable global regulations;
• Demonstrate exceptional written and verbal communication skills, with the ability to clearly articulate complex quality requirements and agreements to internal and external stakeholders. Influence cross-functional teams through clarity, credibility, and strategic insight;
• Excellent 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 the U.S.

Benefits

We offer a wide range of benefits including:

• Competitive wages: $90,000 to $105,000 USD;
• Medical, dental, and vision benefits;
• 401k retirement savings plan with a healthy match;
• Vacation and sick time;
• Career development opportunities;
• Continuing education.

About CellCarta

CellCarta is a leading provider of specialized precisio