Director of Global Quality
Posted on Apr 5, 2021 by 10X Genomics
About the role:
10x Genomics is seeking an outstanding Director of Global Quality Assurance. 10x continues to expand its Operational, Commercial and R&D activities globally in AMER, EMEA and APAC. This person will be responsible for the strategic development and management of the 10xs Global QA function and alignment with key business partners. There is a key requirement to work with all functional groups within 10x to guide the development and implementation of business processes that conform to the chosen quality standard.
The successful candidate will have demonstrated successful experience in establishing and administering an effective Quality Management System, including CAPA, NCR and RMA processes. Also managing specific functions within this group such as Supplier Quality, Design Quality, Process Quality, Document Control, Lean Six Sigma. Experience in leading a company through successful ISO9001 and ISO13485 certification is required.
Qualified candidates must have relevant knowledge and experience in life sciences and serviced markets. A high level of communication skills is required to ensure seamless interaction across the multifunction teams at 10x Genomics. The ideal candidate is self-motivated and driven in implementing and managing world class quality processes that align with and propel business success.
What you will be doing:
Manage the Quality Assurance team.
Continued development of 10x Genomics Quality Management System.
Set up and monitor global quality metrics for various functional groups.
Manage the Quarterly Quality Reviews and manage subsequent actions required to ensure high quality products to our customers.
Collaborate with the R&D Program Management team to continuously develop and implement the product development process to manage design quality.
Continued development and management of Global QA processes required for operations, such as RMA, CAPA, discrepancy reporting, supplier quality.
Establish regulatory requirements and manage the path to compliance as required. Be the project sponsor and lead to achieve ISO13485 certification.
Drive efficient compliance to international standards and regulatory requirements.
Establish processes and guidance for any product certification required, such as 510(K), UL, CE, TUV.
Manage Document Control, and other functions, such as SPC monitoring and Lean Six Sigma.
Active communication with all functional teams to monitor and guide compliance with chosen quality standards.
To be successful in this role, you must have:
Bachelors degree or higher in a relevant scientific discipline - Molecular Biology, Analytical Chemistry or Chemical Engineering. Technical awareness of 10x products and process is required.
Formal training and certification in Quality Assurance management
Demonstrated and proven capability in setting up and managing an effective quality system.
Minimum of 10 years relevant industrial experience in Life Sciences in a hands-on Quality Assurance capacity, demonstrating capability in all aspects of the job requirements.
Experience in different functions of Operations or R&D is beneficial.
Ability to manage a global quality assurance in an unbiased and consistent standard.
Strong teamwork, leadership, organization and communication skills