Quality Management System

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• Our client is launching a major initiative to transform its Quality Management System (QMS), and we are seeking a hands‑on Quality Technical Lead to perform the technical and operational aspects of this effort.
• This is an individual contributor role with a strong focus on business systems analysis (BSA), process definition, and software testing, not a traditional project manager position.
• This role requires deep eQMS expertise, strong analytical skills, and a proactive approach to problem‑solving.
• The ideal candidate will bring a supply chain and manufacturing background, understanding of core quality validation processes, deep experience in medical device and regulatory environments, and the ability to bridge IT and business operations.
• This role will be instrumental in defining and validating processes, gathering requirements, and supporting system testing.

• Lead the technical execution of the QMS transformation project, ensuring it is configured correctly and meets the organization's requirements.
• Define and document process requirements in collaboration with Quality, Manufacturing, and Supply Chain teams.
• Perform software testing and QA validation (non‑regulatory) to ensure system functionality and alignment with business needs.
• Act as a technical SME on QMS systems, supporting configuration, testing, and implementation.
• Collaborate with Quality to ensure system capabilities meet operational and compliance requirements.
• Support SEO, manufacturing, and engineering teams in transitioning to new digital quality workflows.
• Drive hands‑on execution of testing, validation, and process mapping activities.
• Provide input into future PMO structure and governance as the quality function matures.
• No direct reports (This position will not have management responsibilities).

• Bachelor's degree in information systems or related field.
• 58+ years of experience with eQMS systems, including hands‑on configuration and support. Familiarity with Master Control a plus.
• Strong experience in Quality Systems, Supply Chain, and Manufacturing within medical device and regulated environments.
• Proven experience in eQMS implementation, with a strong understanding of quality processes and IT interfaces.
• Proven ability to implement technical programs and define business processes.
• Experience with software testing, QA validation, and requirements documentation.
• Understanding of QMS platforms and their integration with IT systems.
• Ability to work independently and drive initiatives as an individual contributor.
• Strong communication and stakeholder engagement skills.
• Program management experience with a technical edge; ability to balance IT and business needs.
• Familiarity with SEO or digital quality tools.
• Change management exposure or training.

• Mid‑Senior level

• Contract

• Quality Assurance

• Pharmaceutical Manufacturing