Manager, Quality Management System and Supplier Quality (Remote)

CellCarta; Northern (KY); Hybrid; USD 88,000 - 117,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

401k retirement savings plan with a 건강

Vacation and sick time

Career development opportunities

Continuing education

Job summary

CellCarta in the United States is seeking a Manager, Quality Management System and Supplier Quality to lead and harmonize the QMS and supplier qualification efforts, supporting proposals and collaborating with a multidisciplinary team to advance human health.

The role oversees policy development, supplier audits, SCAR handling, and integration of ISO13485/ISO15189 and GMP requirements, with primary interface to corporate suppliers and global regulatory alignment.

Qualifications

• Minimum bachelor’s degree in life sciences, applied sciences, business, or related field.
• Minimum of 5 years' industry or related experience, 2 years of audit experience.
• Knowledge and experience with supplier quality systems GCLP and GMP requirements.
• Knowledge of ISO13485, ISO15189 framework and CAP/CLIA requirements.
• Experience interfacing with suppliers and aligning on a quality agreement framework.
• Ability to merge business and compliance needs to achieve effective solutions.
• Knowledge of compliance requirements for different stages of development, must have knowledge of applicable global regulations.
• Must have demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity.
• Excellent project management skills.

Responsibilities

• Aid in the development and improvement of harmonized policies, procedures, work instructions to meet site and business needs and to comply with external requirements.
• Establish reports to gather and analyze quality data as an input into Corporate Management Review.
• Aid in the coordination of document control, including revisions, training assignment, and issuance of corporate procedures and policies.
• Supports the Supplier Quality Program by classifying and qualifying suppliers, auditing suppliers, maintaining quality agreements with corporate suppliers, serving as a primary interface with corporate suppliers, maintaining a system for Supplier Corrective Action Requests (SCAR), and maintaining the global approved supplier list and audit schedule.
• Aid in the development and execution of an IT third party vendor management program.
• Acts as key team member for software development projects, providing support throughout the software development lifecycle (SDLC), including planning, requirements, risk management, design, verification, validation, release, and change management.
• Participate with ISO certification audits, ISO-27001, ISO13485. Serve as a subject matter expert on Quality Management Systems.

Skills

Quality management systems

Auditing

Supplier quality

Regulatory knowledge

Project management

Communication skills

Education

Bachelor's degree

Job description

Manager, Quality Management System and Supplier Quality (Remote)

Are you looking to take the next step in your career? CellCarta, a Contract Research Organization, is seeking a Manager, Quality Management System and Supplier Quality to join our dynamic team. In this role, you will support proposal development while collaborating with talented professionals dedicated to advancing human health.

Summary

The Manager of Quality Management System and Supplier Quality is responsible for leading and supporting the development and sustainability of the Quality Management System (QMS) at CellCarta by harmonizing quality procedures and processes and providing quality data for the Corporate Quality Management Review. This position serves as a leading in classifying and qualifying suppliers used by CellCarta.

Responsibilities

• Aid in the development and improvement of harmonized policies, procedures, work instructions to meet site and business needs and to comply with external requirements.
• Establish reports to gather and analyze quality data as an input into Corporate Management Review.
• Aid in the coordination of document control, including revisions, training assignment, and issuance of corporate procedures and policies.
• Supports the Supplier Quality Program by classifying and qualifying suppliers, auditing suppliers, maintaining quality agreements with corporate suppliers, serving as a primary interface with corporate suppliers, maintaining a system for Supplier Corrective Action Requests (SCAR), and maintaining the global approved supplier list and audit schedule.
• Aid in the development and execution of an IT third party vendor management program.
• Acts as key team member for software development projects, providing support throughout the software development lifecycle (SDLC), including planning, requirements, risk management, design, verification, validation, release, and change management.
• Participate with ISO certification audits, ISO-27001, ISO13485. Serve as a subject matter expert on Quality Management Systems.

Education

• Minimum bachelor’s degree in life sciences, applied sciences, business, or related field

Main Requirements

• Minimum of 5 years' industry or related experience, 2 years of audit experience
• Knowledge and experience with supplier quality systems GCLP and GMP requirements.
• Knowledge of ISO13485, ISO15189 framework and CAP/CLIA requirements.
• Experience interfacing with suppliers and aligning on a quality agreement framework.
• Ability to merge business and compliance needs to achieve effective solutions.
• Knowledge of compliance requirements for different stages of development, must have knowledge of applicable global regulations.
• Must have demonstrated written and verbal communication skills, including ability to articulate complex quality agreements with clarity.
• Excellent project management skills.

Working Conditions

• Working hours: Monday to Friday, 9:00 AM to 5:00 PM, with 100% remote work.
• Must be based in the U.S., ideally in the Eastern Time Zone

What We Can Offer

• Competitive wages: $87,900 to $117,200
• Medical, dental, and vision benefits
• 401k retirement savings plan with a healthy match
• Vacation and sick timeCareer development opportunities
• Continuing education

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].