Qc Laboratory Supervisor

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:
Our team is at the heart of Dexcom products! You will join a collaborative, cross-functional team that helps ensure quality, safety, and efficacy of our products to empower people to take control of their health. As a QC Laboratory Supervisor, you will oversee our skilled analysts while collaborating with research and development scientists, sustaining quality and process engineers, and process development engineers to develop and improve test methods and to maintain cGMP compliance. You will provide guidance and training to cross-site technical personnel, and incoming new hires, as needed. A positive attitude is important while working in a fast-paced environment and dealing with shifting priorities.
Where you come in:

• You oversee day-to-day operations of the Analytical QC commercial laboratory activities, including analytical instrument procurement, installation, qualification, maintenance, calibration, and compliance with QMS procedures and applicable regulations and quality standards.
• You lead and mentor skilled technicians, ensuring their training, development, and performance.
• You collaborate cross-functionally with R&D, Regulatory Affairs, Quality Assurance, and Manufacturing teams to resolve quality issues, as well as to develop, validate, and improve state of the art Standard Operating Procedures (SOPs) and analytical methods for testing medical device and/or drug-device combination products.
• You manage, review, and approve quality control testing on critical raw materials, product intermediates, and finished products, ensuring specifications are met.
• You ensure the laboratory operates in compliance with FDA and other relevant regulations and standards for medical device and combination products. You maintain up-to-date knowledge of industry standards and changes in regulations, participating in audits and inspections, addressing findings and implementing corrective actions.
• You maintain accurate records for all laboratory activities, including test results deviations, and reports.
• You identify and manage risks related to analytical quality control processes and lead/support investigations of deviations or results that are out-of-specification.
• You develop and manage the laboratory budget, optimizing resources for efficient operation and supporting inventory management and procurement of supplies, reagents, and consumables.
• You drive continuous improvement initiatives within the laboratory to enhance efficiency, accuracy, and compliance.
• You maintain a safe working environment and ensure that the team adheres to safety protocols and 6S practices.

What makes you successful:

• You have a background in Analytical Chemistry and several years of experience in analytical QC in the pharmaceutical or medical device industry.
• You bring a strong knowledge of regulatory requirements for medical device and combination products (e.g. 21 CFR Part 4 and 820, ICH guidelines, etc.)
• You are an experienced leader and manager.
• You are proficient in complex analytical techniques and instruments (e.g. GPC and HPLC), as well as defining and executing test method validation.
• You have excellent problem-solving skills and attention to detail.
• You bring knowledge of asset management software and LIMs or other recordkeeping techniques.

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 5-8 years of industry experience
• Informal management/ team lead experience

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 talentacquisition@dexcom.com.
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 talentacquisition@dexcom.com.
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: 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:
$82,900.00 - $138,100.00