Manager Quality Compliance

Dexcom

1d • Remote

About The Position

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: As a Clinical Quality Manager, you will be responsible for overseeing various aspects of quality management within the organization, with a focus on clinical operations. You will play a critical role in ensuring adherence to regulatory standards, maintaining high-quality standards, and fostering a culture of continuous improvement. You will collaborate cross-functionally with various departments to drive clinical quality initiatives and support the company's objectives. Where you come in: Quality First and Safety Management: Promote a culture of quality Manage clinical safety oversight Implement measures to ensure product quality and patient safety Champion continuous improvement initiatives Protocol Review: Review and approve clinical study protocols Ensure protocols are in compliance with regulatory requirements and company standards Collaborate with cross-functional teams to optimize study designs PMCF (Post-Market Clinical Follow-up) Review: Lead the review and management of post-market clinical follow-up activities. Ensure compliance with regulatory requirements and company standards Vendor Qualification: Develop and implement vendor qualification processes Evaluate and qualify vendors according to established criteria Support vendor performance and adherence to quality standards Audit Lead/Support: Lead or support internal and external audits as required Develop audit plans and schedules Coordinate audit responses and follow-up on corrective actions Procedure Development: Develop and maintain quality procedures and work instructions Ensure procedures are aligned with regulatory requirements and best practices Train staff on quality procedures and ensure adherence CAPA (Corrective and Preventive Action) Management: Lead the CAPA process, including investigation, root cause analysis, and implementation of corrective/preventive actions Monitor CAPA effectiveness and closure within established timelines Validation Review/Approval: Review and approve validation protocols and reports Ensure validation activities are conducted in compliance with regulatory requirements and industry standards Cross-Functional Collaboration: Collaborate with cross-functional teams to address quality-related issues and drive improvements. Act as a subject matter expert on quality matters and provide guidance to stakeholders eTMF (Electronic Trial Master File) Management: Oversee the management of the electronic trial master file system Ensure eTMF completeness, accuracy, and compliance with regulatory requirements Document System Oversight: Provide oversight of document management systems Ensure proper documentation practices and version control Implement improvements to streamline document processes What makes you successful: Experience working in clinical research and knowledge of clinical trial design and analysis. Minimum of 3 year in Clinical Quality role Experience in audit support Excellent communication and presentation skills, with the ability to communicate results and insights to non-technical stakeholders. Ability to work independently and collaboratively in a team environment. Familiarity with continuous glucose monitoring devices and diabetes management is a plus What you’ll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: Typically requires a Bachelor’s degree with 8-12 years of industry experience 2-5 years of previous management or lead experience Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom’s AAP may be viewed upon request by contacting Talent Acquisition at [email protected]. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at [email protected]. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true 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. Salary: $111,100.00 - $185,100.00 Since 1999, Dexcom has simplified and revolutionized diabetes management, positively impacting millions worldwide. At Dexcom, we're more than just a medical device company; we're a collective of visionary thinkers, trailblazers, and problem solvers. Our mission transcends the ordinary. We aim to revolutionize healthcare, one groundbreaking technology at a time.

Requirements

• Experience working in clinical research and knowledge of clinical trial design and analysis.
• Minimum of 3 year in Clinical Quality role
• Experience in audit support
• Excellent communication and presentation skills, with the ability to communicate results and insights to non-technical stakeholders.
• Ability to work independently and collaboratively in a team environment.
• Typically requires a Bachelor’s degree with 8-12 years of industry experience
• 2-5 years of previous management or lead experience

Nice To Haves

• Familiarity with continuous glucose monitoring devices and diabetes management is a plus

Responsibilities

• Promote a culture of quality
• Manage clinical safety oversight
• Implement measures to ensure product quality and patient safety
• Champion continuous improvement initiatives
• Review and approve clinical study protocols
• Ensure protocols are in compliance with regulatory requirements and company standards
• Collaborate with cross-functional teams to optimize study designs
• Lead the review and management of post-market clinical follow-up activities.
• Ensure compliance with regulatory requirements and company standards
• Develop and implement vendor qualification processes
• Evaluate and qualify vendors according to established criteria
• Support vendor performance and adherence to quality standards
• Lead or support internal and external audits as required
• Develop audit plans and schedules
• Coordinate audit responses and follow-up on corrective actions
• Develop and maintain quality procedures and work instructions
• Ensure procedures are aligned with regulatory requirements and best practices
• Train staff on quality procedures and ensure adherence
• Lead the CAPA process, including investigation, root cause analysis, and implementation of corrective/preventive actions
• Monitor CAPA effectiveness and closure within established timelines
• Review and approve validation protocols and reports
• Ensure validation activities are conducted in compliance with regulatory requirements and industry standards
• Collaborate with cross-functional teams to address quality-related issues and drive improvements.
• Act as a subject matter expert on quality matters and provide guidance to stakeholders
• Oversee the management of the electronic trial master file system
• Ensure eTMF completeness, accuracy, and compliance with regulatory requirements
• Provide oversight of document management systems
• Ensure proper documentation practices and version control
• Implement improvements to streamline document processes

Benefits

• A front row seat to life changing CGM technology.
• Learn about our brave #dexcomwarriors community.
• A full and comprehensive benefits program.
• Growth opportunities on a global scale.
• Access to career development through in-house learning programs and/or qualified tuition reimbursement.
• An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees