Associate Director, QA (Ref: 4014BR)

All About Us
Do you want to make a difference? Illumina’s mission is to improve humanhealth by unlocking the power of the genome. If that inspires you, let’stalk. We’ve built a culture fuele******** ******** collaborationan********, an******** ourselves as the global leader in DNA sequencingan********-base********. Our people an******** technology change livesby driving advancements in life sc******** oncology, reproductivehealth, agriculture an******** emerging markets. We are deeplypassionate about what we ******** because we know that our work has thepower to improve lives.

We’re an establishe******** with a track recor******** phenomenalgrowth. Our revenue grew from $10 million in 2002 to approximately $2.2billion in 2015. Our growth isn’t just revenue, we’ve been hiring thebest an******** brightest. Perhaps that’s why MIT has ranke******** nearthe top of its World’s Smartest Companies list three years runn********including #1 in 2014. If you thrive in a br******** fast-paced,an********-driven env******** Illumina is the place for you – imaginethe possibilities.

Position Summary:

This position is responsible for Quality activities that measure,mon******** an******** Illumina’s compliance with the Quality SystemRegulat******** Illumina Quality pol******** cFDA/FDA regulationsan******** standards as well as Illumina product quality for currentoperation an******** objectives.

Tasks an****************

•Supports the distribution warehouse with focus on compliance withapplicable China GMP Quality Management System, Quality SystemRegulations (QSR), ISO 13485 requirements an******** Goo********Practice
•Ensures adequate control of nonconforming material.
•Manage ******** disposition an******** processes.
•Develop, review an******** Quality System documents (e.g.,Standar******** Proce******** Forms, Spec******** Val******** etc.) toensure compliance with applicable regulations (e.g., GMP, GDP, ********ISO, etc.)
•Monitor an******** key metrics an******** improvements to distributionprocesses.
•Facilitate the training program require******** Illumina customerfacing personnel.
•Ensure that records are complete, accurate an********.
•Support development an******** of process verification an********plans.
•Review an******** planne******** unplanne****************
•Collaborate with the Global Quality team to oversee, support,facilitate and/or drive the following area********◦Change managementactivities
◦Compla******** recall, fiel********
◦Compliance Au******** inspections
◦Suppliers / Service providers management
◦Quality Management Review
•Other such duties that may be determine******** Management.
•Partner/collaborate with Illumina’s Regulatory Affairs to assure thesuccessful approval an******** compliance with the APAC regionrequirements.
•Partner/collaborate with Illumina’s Commercial an******** organizationsto support the Quality Assurance elements of commercial agreements,channel partners, an******** agreements with customers an********.
•Develop the Quality/Regulatory strategic plans require******** enableIllumina’s China NGS market for both RUO an******** products.

All liste******** an******** are deeme******** essential functions tothis position; however, business conditions may require reasonableaccommodations for additional task an********.

All About You
Requiremen********

•Experience in Goo******** Practice (GDP)
•Experience in supporting logistic******** environment
•Experience in col******** an******** validation highly desired.
•Six Sigma/Lean training;
•Experience in CAPA an********;
•Project management certification
•Working for a Medical Device or Medical Diagnostics company;
•ISO 13485 an******** 9001 experience
•China FDA regulatory experience

Competencie********

•Ability to apply experience in meeting requirement of China Goo********Practice an******** 13485 Standard.
•Experience in applying appropriate quality tools.
•Effective failure ******** technical report wr******** data m********tren********, statistical analysis.
•Intermediate to advance******** with words processing an********,chart******** graphing tools an******** tools.
•May have experience with electronic production life (PLM), enterpriseresource planning tools (SAP) an********. Experience with SAP PLMpreferred.
•May have experience with statistical analysis packages, eg, JMP,minitab.
•Must be detaile********, well organize******** able to workindependently an******** teams.
•Preferre******** in spoken an******** english communication.

Educational:

•Bachelor’s Degree in Engineering or Biological/Life Sciences
•Master’s Degree preferred
•More than 5 12 years of working experience in a regulate********environment