Clinical Quality Manager - California, United States - 1 DexCom Inc

Description

Founded in 1999, Dexcom, Inc

(NASDAQ:

DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes.

The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes.

Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes.

Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021.

Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

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

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
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
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 years of industry experience.

• 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

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

View the OFCCP's Pay Transparency Non Discrimination Provision at this link .
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.

About Dexcom
Founded in 1999, Dexcom, Inc

(NASDAQ:

DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes.

The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes.

Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes.

Dexcom reported full-year 2022 revenues of $2.9B, a growth of 18% over 2021.

Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 8,000 people worldwide.

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 years of industry experience.

• 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

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

View the OFCCP's Pay Transparency Non Discrimination Provision at this link .
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:

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:
$105, $176,300.00
WHY CHOOSE DEXCOM?

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.

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