drjobs Senior Manager IT Enterprise Applications

Senior Manager IT Enterprise Applications

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1 Vacancy
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Job Location drjobs

San Diego, CA - USA

Monthly Salary drjobs

$ 141800 - 236400

Vacancy

1 Vacancy

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 were 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 weve 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. Weve already changed millions of lives and were 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. Well get there by constantly reinventing unique biosensingtechnology experiences. Though weve 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:

We are seeking an experienced Senior Manager of IT to lead and optimize our Quality Organizations portfolio of Enterprise Applications. This leader is experienced and adept in solving complex business challenges and finding success in an fluid and some times ambiguous global environment.

The candidate will have subject matter expertise and handson managing technical teams responsible for Software Quality Change Control Configuration Management Document control Training QMS NCR CAPA Audits writing Quality plans/SOPs Validation and Verification Quality Metrics and Software Development.

Enterprise Application management experience in Product Lifecycle Management (PLM) processes within the pharmaceutical or medical device industry is required. The ideal candidate will have extensive experience in managing PLM systems driving digital transformation and ensuring compliance with industry regulations. This role requires a strategic thinker who can collaborate crossfunctionally to enhance product development data governance and operational efficiencies.

Where you come in:

  • Lead Dexcoms endtoend Oracle Cloud PLM strategy implementation and continuous improvement efforts across the organization.
  • Manage the integration of PLM with Finance ERP MES QMS and regulatory compliance tools to ensure seamless product data management.
  • Ensure compliance with FDA ISO 13485 GMP and other relevant regulatory standards for medical devices and pharmaceuticals.
  • Collaborate with R&D Quality Regulatory Affairs Manufacturing and IT teams to standardize and optimize PLM processes.
  • Oversee product data governance including Bill of Materials (BOM) management change control and document control processes.
  • Drive the digital transformation of PLM by implementing best practices automation and data analytics.
  • Manage PLM system upgrades enhancements and validation in a regulated environment.
  • Train and mentor teams on PLM best practices system usage and compliance requirements.
  • Business Partnerships across the Quality organization and portfolio of Enterprise Systems supporting groups such as Global Customer Advocacy Global Tech Support Clinical Medical Affairs.
  • Partner with external vendors and IT teams to support system maintenance troubleshooting and improvements.

What makes you successful:

  • 8 years of experience in PLM management with a strong background in the pharmaceutical or medical device industry.
  • Handson experience with PLM platforms such as Oracle Cloud PLM.
  • Strong understanding of regulatory requirements validation processes and compliance standards (FDA ISO GMP GxP 21 CFR Part 11 etc..
  • Experience leading crossfunctional teams and managing complex projects in a regulated environment.
  • Knowledge of integrations with ERP MES and QMS systems.
  • Knowledge of Veeva suite of products supporting Quality Clinical Medical Affairs Vault.
  • Knowledge of Smarteeva supporting Customer Advocacy.
  • Experience working in Quality organizations and collaborating with Manufacturing teams.
  • Excellent problemsolving communication and leadership skills.
  • Experience in data migration system implementation and change management.

Experience and Education Requirements

Please note: The information contained herein is not intended to be an allinclusive list of the duties and responsibilities of the job nor are they intended to be an allinclusive 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. Dexcoms 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 OFCCPs Pay Transparency Non Discrimination Provision at this link.

Meritain an Aetna Company creates and publishes the MachineReadable Files on behalf of Dexcom. To link to the MachineReadable Files please click on the URL provided: 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:

$141800.00 $236400.00

Required Experience:

Senior Manager

Employment Type

Full-Time

About Company

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