SVP Quality Assurance en Dexcom

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.

Overview:

The Senior Vice President, Quality Assurance will be a leader and champion of Dexcom’s culture of quality and will be responsible for the design and achievement of its goals with respect to quality of products and services across multiple product areas, manufacturing facilities, product design locations and a global supply chain. Will implement the company’s Quality strategy and policy development and direct the functional resources for the company to demonstrate compliance with ISO, Canadian Medical Device Requirements, CE Medical Device Directives and FDA requirements. In addition, will develop and lead the implementation of Dexcom’s Quality strategy and programs, while serving as a business partner to Dexcom’s leadership.  

Where you come in:

• You will lead the Quality Assurance organization in setting the strategic vision, strategy, fostering innovation, and enabling the achievement of the corporate strategy, mission, business growth and objectives.
• You will serve as the Designated Management Representative, responsible for ensuring the adequacy of the Quality System, conducting Management Review, and ensuring employees are aware of regulatory and quality requirements.  Assure that all departments and facilities are in conformance with the Quality and Regulatory requirements. 
• You will oversee a global team which manages, among other things, Corporate Quality Management System (QMS), Supplier Quality, Design Assurance, Manufacturing Quality, QMS Training, Corporate Document Control, Enterprise Software Quality, Corporate Internal Audit Program, External Audit Readiness Processes, Corporate CAPA, Corporate Management Review, Corporate Post-Market Surveillance Program, Field Actions, Licensing (Domestic State / Global Manufacturing), Global Site Registrations, and EU MDR Importer.

• You will oversee compliance with FDA, MDD, ISO, and similar regulations and manage inspections by regulatory agencies and bodies. 

• You manage Dexcom’s Incident and Complaint processes, including failure investigation tracking and trending activities, reporting, and CAPA implementation effectiveness. 

• You will develop and implement audit plans and audit schedules for external compliance audits of raw material suppliers, contractors, collaborators, and other relevant organizations; recommend and assist in preventive and corrective actions, as required. 

• You will define Quality strategies for products in development, implement design control procedures and practices and provide guidance to product development teams. 

• You lead and manage a Quality team through the various stages of product development and clearance/approval, interacting with US and international regulatory authorities or notified bodies, and implementing Quality systems, including certification processes. 

• You perform, and ensure staff performs, all responsibilities in accordance with appropriate industry and Good Clinical and Good Manufacturing Practices standards, MDD, ISO standards, and Canadian quality standards.  Ensure site and contract research organizations are performing services in accordance with company Standard Operating Procedures and appropriate industry and regulatory guidelines, rules, and regulations.  Recommend corrective actions. 

• You train, mentor, and oversee the work of other department personnel, including orientation of department and company procedures and policies, regulatory agency relationships, and making presentations.  Provide appropriate coaching and career development. 

• You demonstrate leadership abilities by leading successful teams, being results driven, exhibiting knowledge and understanding of company’s strategic focus, and building coalitions and communication among cross-functional groups and third-party vendors. 

• You partner closely with management to set quality objectives, and to achieve those objectives. 

• You and your team are the external authority liaison for compliance concerns and will proactively monitor and react to regulatory changes globally to ensure that the company remains compliant.
• You oversee the assessment of the compliance of products and procedures with existing regulatory requirements in current markets to include reviewing and approving Health Hazard Assessments and will be part of the required quorum for making recall decisions.
• You will direct and/or conduct investigations into potential quality/compliance concerns while keeping executive management informed of issues.

What makes you successful:

• Your excellent communication skills (oral/written), executive presence, and agility to navigate with finesse across different nationalities & stakeholder groups including at the senior management level
• Your ability to organize, motivate and lead diverse teams in a quickly growing and agile/flexible corporate environment
• Your strong ability to assess talent, build high performing teams and ensure the organization is structured and staffed to successfully deliver on objectives

• Your demonstration of being results-oriented, self-disciplined, fast-paced, and motivated with the ability to deal with ambiguity – ready to change gears and plans quickly
• Your decisiveness as a leader with a strategic focus as well as an operational, implementation perspective
• Your high level of collaboration and desire to reach across the organization to understand stakeholder needs and how to meet those needs
• The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results

• You are comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations
• You are a leader who is viewed by others as having a high degree of integrity and forethought in his/her approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization
• You naturally connect and build strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.

Experience and Education:

• Typically, 20+ years of industry experience with 15+ years of successful leadership experience in healthcare (pharmaceuticals, biotechnology, medical technology).
• Bachelor’s degree in engineering or related field. Advanced degree preferred.

Travel Required:

• 25 to 50%

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: