Katalyst CRO · 1 month ago
Quality Management System
Andover, MA
Contract
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst CRO is seeking a hands-on Quality Technical Lead to transform its Quality Management System (QMS). This role focuses on business systems analysis, process definition, and software testing, requiring deep eQMS expertise and strong analytical skills.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
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)
Qualification
Required
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
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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