Manager, Quality Assurance - Molecular Diagnostics - 6778BR

Illumina, Inc.
Job Location
San Diego, CA 92121
Job Description

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. Life at Illumina is about working with teammates who 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. Just check out our investor events and presentations to learn about our financial accomplishments. Our growth isn’t just in financials, we’ve been busy hiring the best and the brightest. Perhaps that’s why MIT has ranked Illumina near the top of its World’s Smartest Companies each of the last three years. If you thrive in a brilliant, fast-paced, and mission-driven environment, Illumina is the place for you. Join the journey of a lifetime. Join Illumina.


  • 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
  • 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. If you have a disability or special need that requires accommodation, please contact us at 858-246-8959. To learn more, visit:

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