Why is one person more likely to develop a disease, like cancer, than someone else? Why would one person respond differently to treatment than another? Illumina’s technologies are helping researchers and clinicians around the world answer these questions and others, on a scale not even possible a few years ago.
Illumina is the only life sciences company developing genome-wide technologies for genotyping, gene expression and sequencing—the three cornerstones of modern genetic analysis. By enabling studies of thousands of patient samples at once, our products set genetic discovery on fast forward. And we’re just getting started.
This position manages quality activities at Illumina’s clinical lab site and ensures that Quality Systems are established, implemented, and maintained in compliance with all appropriate regulatory standards, including federal, state and local. The ideal candidate will have a Quality background in in vitro diagnostics and some experience in a molecular reagent company specializing in molecular biology products or molecular diagnostic products utilizing nucleic acid technology (e.g. PCR, sequencing, etc).
- Act as the clinical quality system manager, ensure the Quality Systems are established, implemented, and maintained in compliance with all appropriate regulatory standards, including federal, state and local; acts as the main point of contact for all external audits/assessments
- Oversee and assist in the development of the Internal Audit program, external audit program, proficiency testing, and management of audit corrective actions
- Coordinate regular Quality Systems meetings reviewing quality metrics
- Work with company management as well as the CAPA program manager to resolve incidents, develop corrective actions and monitor the effectiveness of resolutions
- Oversee the CAPA as well as non-conformance processes; assists with managing the document control system as well as the archiving of records according to the San Diego clinical lab site’s retention schedule
- Manage the updating and creation of QSEs and WIs for the quality department including annual review; ensure documentation of lab procedures and completion of DHF
- Ensure changes in products, procedures, and training are implemented correctly
- Manage the creation or purchase of training materials for the implementation of Quality Systems/Quality tools, ensures there is training for end-users and perspective trainers; works with training coordinator to ensure appropriate training on all procedures; including new and revised procedures
- Participate in Product Quality reviews, management reviews and preparation of Quality reports
- Coordinate site Quality System assessments and provide recommended roadmaps for improvement
- Develop and review validation and verification reports while ensuring a successful implementation of newly developed assays
Skills & Experience
- Bachelor’s degree in a life science, preferably Biology or equivalent; advanced degree in molecular science desirable, Regulatory Affairs Certification desirable
- 10+ years’ experience in Quality Assurance and/or laboratory experience in the molecular diagnostic industry, with general knowledge of statistical analysis
- Minimum of 4 years’ people management experience
- Must have experience in working with laboratory equipment including thermocyclers, Sequencers, PCR and utilizing Taqman analysis
- Experience as the team lead for client and regulatory audits including FDA , CAP, NY, CLEP and any additional agencies as required
- Prior experience in a clinical lab (CAP, NYS, CLIA) highly preferred
- Must possess an understanding of the fundamental principles and concepts of molecular biology, genetics, and how these relate in a clinical setting along with work flow through all phases of laboratory operations
- Careful and accurate documentation of work
- Excellent problem solving and analytical skills
- Effective interpersonal and communication skills and capable of supporting cross-functional project goals
- An understanding of Quality Systems, HIPPA, CAP, CA, NY CLEP and CLIA policies and safety procedures is required
Illumina believes that everyone has the ability to make an impact, and 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.
Do you want to make a difference? Illumina’s mission is to improve human health by unlocking the power of the genome. If that inspires you, let’s talk. We’ve built a culture fueled by innovation, collaboration and openness, and established ourselves as the global leader in DNA sequencing and array-based technologies. Our people and our technology change lives by driving advancements in life sciences, oncology, reproductive health, agriculture and other emerging markets. We are deeply passionate about what we do, because we know that our work has the power to improve lives.
We’re an established company with a track record of phenomenal growth. Our revenue grew from $10 million in 2002 to approximately $2.4 billion in 2016. Our growth isn’t just revenue, we’ve been hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its “World’s Smartest Companies” list each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you – imagine the possibilities.