Sr Business Systems Analyst

Dexcom; George Town; On-site; MYR 120,000 - 180,000; Full time

Job summary

Dexcom seeks a senior IT Validation specialist to lead governance of CSV/CSA activities across MES, ERP, QMS, and related systems. You will ensure regulatory compliance and inspectability while partnering with IT, OT, Quality, and Manufacturing teams to drive risk-based validation across the SDLC.

The role emphasizes delivering Validation Plans, Protocols, and Reports, along with continuous improvement of quality systems and procedures. Strong communication and project leadership are essential.

Qualifications

• Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or a related discipline.
• Minimum of 5 years of direct experience validating manufacturing systems and regulated computer systems.
• Proven experience validating enterprise systems such as MES, ERP, QMS, EDMS, LIMS, and control systems.

Responsibilities

• Lead validation activities (CSV/CSA) for IT and OT systems.
• Develop Validation Plans, Protocols, Risk Assessments, and Traceability Matrices.
• Ensure compliance with FDA/Regulatory requirements and inspection readiness.
• Communicate progress and risks to cross-functional teams and leadership.
• Drive continuous improvement in validation processes and quality systems.

Skills

Validation expertise

GxP compliance

FDA 21 CFR Part 11

CSV/CSA

Risk assessments

Project leadership

Regulatory knowledge

Communication

Education

Bachelor's degree in Engineering/Quality/CS Life Sciences

Tools

Microsoft Office

Excel

MiniTab

Database applications

Job description

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

The Company

Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.

We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.

Meet The Team

Join our dynamic IT department at Dexcom, where innovation meets expertise in cost accounting within our Oracle EBS environment. As a crucial member of our team, you will be at the forefront of optimizing cost accounting processes, ensuring accuracy, efficiency, and compliance. With a supportive and collaborative atmosphere, you will have the opportunity to make a tangible impact on Dexcom's financial operations while working alongside talented professionals who share your passion for excellence. This position will involve supporting multiple APAC IT projects and may entail leading small projects as needed. Dexcom has regional teams in APAC, EMEA and US and this role will be functionally part of this wider team and will operate within its governance framework.

Where You Come In

• Serve as the Subject Matter Expert (SME) for validation and compliance of Enterprise and Manufacturing Systems, including MES/Camstar, ERP, QMS, SCADA, PLC, Data Historians, EBR, and other GxP-regulated platforms.
• Lead verification and validation activities, including Computer System Validation (CSV), Computer Software Assurance (CSA), Process Validation (IQ/OQ/PQ/PPQ), Test Method Validation, and Validation Master Planning.
• Provide QA and QC requirements, guidance, and oversight for IT and Operational Technology (OT) systems while ensuring regulatory compliance and inspection readiness.
• Perform GxP risk assessments at the system, functionality, and data-element levels, applying risk management principles, sample size determination, and external standards review.
• Serve as a core advisor to IT, OT, Quality, Manufacturing, and cross-functional teams by providing expertise on validation strategies, quality systems, compliance requirements, and risk mitigation.
• Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable domestic and international regulations.
• Develop, execute, and maintain validation deliverables throughout the SDLC, including Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Test Scripts, and Summary Reports.
• Effectively communicate project progress, validation status, compliance risks, and key challenges to broad Dexcom teams and senior leadership.
• Independently lead validation initiatives and project activities across cross-functional teams and projects of varying complexity.
• Design and continuously improve policies, procedures, and quality systems supporting validation, auditing, CAPA, calibration, training, document control, customer complaints, nonconforming materials, receiving inspection, and process controls.
• Apply Six Sigma, Total Quality Management (TQM), and continuous improvement methodologies to improve product safety, product consistency, compliance, operational efficiency, and cost performance.
• Interpret specifications and inspection criteria while utilizing Microsoft Office, Excel, MiniTab, and database applications to support quality, compliance, and business objectives.
• Perform additional duties and responsibilities as assigned in support of business and quality objectives.

What Makes You Successful

• Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or a related discipline.
• Minimum of 5 years of direct experience validating manufacturing systems and regulated computer systems within medical device, pharmaceutical, or other highly regulated industries.
• Proven experience validating enterprise systems such as MES, ERP, QMS, EDMS, Clinical Data Management Systems, LIMS, and manufacturing automation solutions including PLC, SCADA, Data Historians, and EBR.
• Strong understanding of GxP business processes, Quality Management Systems, FDA electronic records and electronic signature requirements, and computerized system validation expectations.
• Demonstrated expertise in FDA Computer Software Assurance (CSA), risk-based validation methodologies, and Computer System Validation (CSV) principles.
• Comprehensive knowledge of FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, and related regulatory requirements.
• Proven experience delivering full lifecycle CSV programs and maintaining compliance across both IT and OT environments, including 21 CFR Part 11 impacted systems.
• Hands‑on experience creating and executing Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Test Scripts, and other validation documentation across all phases of the SDLC.
• Ability to independently manage projects, prioritize competing demands, and successfully lead cross-functional teams and stakeholders.
• Proven organizational skills and collaboration skills, with experience influencing teams and driving alignment across business and technical organizations.
• Excellent written and verbal communication skills, strong organizational and analytical capabilities, and exceptional attention to detail.
• ASQ Software Quality Engineer (SQE) certification, Medical Device industry experience, expertise in 21 CFR Part 11, and familiarity with 21 CFR 820 are highly desirable.

To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.

AI in Hiring Notice:

We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.

At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.

Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at [e-mail].