Staff Clinical Quality Assurance Specialist

What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.Position Summary: In this quality role, you will collaborate with Clinical Operations and Development on quality and compliance strategy via representation on the product development teams. You will ensure clinical product conformance to applicable safety and quality system regulations and standards (e.g. FDA 21 CFR Part 812, IVDR, ICH, CLIA) in addition to any additional specific country requirements for performing human clinical trials. You will be responsible for guiding teams in execution of design control activities with focus on clinical trial readiness and outcome to positively impact the safety and efficacy of products.  Responsibilities:Provide quality leadership to new product development teams, with a focus on clinical trial readinessEnsure clinical trial design and execution meet requirements of FDA and ISO, when applicableEnsure adequacy of clinical complaint investigations, corrective actions and reporting during clinical trialsDrive severity assessment evaluations with medical lead in support of product risk management activitiesProvide consultation to product development teams regarding data collection, analysis and creation of clinical protocols and reportsEnsure processes contributing to the performance of a clinical trial are conducted properlyPerform clinical supplier and subcontractor qualification auditsInternal operations compliance audits; including procedural and departmental system auditsAudits of key deliverables or study components, including study process documents, trial master files (TMFs), reports, tables, and listingsSoftware and database validation document reviewsIndependent database auditsAnalyze and report on quality data in order to improve product and process; develop recommendations based on data analysisEvaluate clinical quality events, incidents, queries, and complaintsManage of Clinical CAPAsSupport submissions to regulatory agenciesEnsure clinical requirements are communicated through corporate policies and proceduresUtilize guidance documents, international standards, or consensus standards and interpret for guidanceUtilize guidance documents, international standards, or consensus standards and interpret for guidanceCommunicate critical clinical compliance risks to senior managementKeep up to date with all related clinical and quality legislation and compliance issuesProvide GCP training for clinical study monitorsRequirements:8+ years’ experience in a quality assurance field in a regulated environment2-4+ years’ direct experience working in in-vitro diagnostic in a clinical quality assurance role; preferredWorking knowledge of Illumina products and technology (e.g. Array, Sequencing, etc.)Experience working globally across many sitesExperience applying quality regulations and standards (e.g. 21CFR 812, ICH, ISO 13485, ISO 14971, IEC62304, IVDR, CLIA)Highly effective communication, facilitation, coaching, and negotiation skillsAdaptable to fast-paced, dynamic work environment with shifting demandsDemonstrated ability to accomplish goals while working across departments is requiredEducation:Bachelor’s degree in an engineering or technical science discipline#LI-HYBRID#LI-REMOTEThe estimated base salary range for the Staff Clinical Quality Assurance Specialist role based in the United States of America is: $113,600 - $170,400. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly. Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data. Additionally, all employees are eligible for one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits as innovative as our work, including access to genomics sequencing, family planning, health/dental/vision, retirement benefits, and paid time off.At Illumina, we strive to foster a diverse and inclusive workplace by cultivating an environment in which everyone contributes to our mission. Built on a strong foundation, Illumina has always been rooted in openness, collaboration, and seeking alternative views and perspectives to propel innovation in genomics. We are proud to confirm a zero-net gap in pay, regardless of gender, ethnicity, or race. We also have several Employee Resource Groups (ERG) that deliver career development experiences, increase cultural awareness, and demonstrate our collective commitment to diversity and inclusion in the communities we live and work. We are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information. If you require accommodation to complete the application or interview process, please contact accommodations@illumina.com. To learn more, visit: https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf