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Associate Director, Quality Assurance & Regulatory

CDI
Daly City
Salaire : Non spécifié
Télétravail non autorisé

DNA Script
DNA Script

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Le poste

Descriptif du poste

DNA Script

DNA Script is a leading company in manufacturing de novo synthetic nucleic acids using enzymatic DNA synthesis (EDS) technology. The company aims at accelerating innovation in life science and technology through the decentralization of rapid, on demand and high-quality DNA synthesis. DNA Script's approach leverages nature's billions of years of evolution in synthesizing DNA to set a new standard for customizing nucleic acid synthesis thus accelerating discovery in genetics, genomics, and synthetic biology. Discovery disciplines with profound impacts upon humanity such as biopharma, translational genetics and even molecular information storage all start with synthetic DNA. The company has recently initiated the commercialization of its first EDS powered platform, the SYNTAX system.

To date, DNA Script has raised over $315M of financing, with leading investors such as Coatue Management, Fidelity Management and Research, Catalio Capital Management, Casdin Capital, LSP, Bpifrance Large Ventures, Danaher, Illumina Ventures, Agilent, Merck Ventures, Sofinnova Partners, Kurma Partners, T Rowe Price, Baillie Gifford and Eurazeo.

DNA Script also partners on technology and product development with leading organizations such as DARPA, IARPA, Moderna Therapeutics, GE Research, Illumina, the Broad Institute, Harvard University, Institut Pasteur and the French Department of Defense.

DNA Script has its research and manufacturing facilities headquartered in Paris, France, and is in the process of expanding its commercial and development teams in South San Francisco.

Opportunity and Challenges :

We are looking to assemble a team of best-in-class, innovative and passionately eager people. We want to gather their talents and skills to achieve one goal: unlock the power of “DNA-write.” We offer the opportunity of joining a dynamic, international, and highly skilled team in a pioneering startup. Our DNA On Demand platform not only has the potential to change the way the world makes and uses synthetic DNA, but also to accelerate the rate of discovery by delivering upon the promise of same-day results.

This is an opportunity to join a rapidly growing company and to have a large impact on developing a technology that will have far-reaching impacts across biological sciences.

The role

We are opening a new position for a Quality Assurance & Regulatory Affairs (QA/RA) Associate Director to take the lead of the QA/RA department at DNA Script. The QA/RA Associate Director will be in charge of developing, implementing and overseeing long-term strategies in QA, Regulatory and Risk Management activities. This is an amazing opportunity to join a growing department and make a huge impact on a disruptive company.

The QA/RA Associate Director reports to the Quality & Regulatory Director.

Responsibilities

  • Responsible for the development and management of the QA/RA department both in Paris and San Francisco: Create the vision, define and execute the roadmap, and provide leadership for the team (currently 3 people & one opened position)
  • Define, execute or support critical cross-departmental projects and initiatives within the QR organization (e.g. ISO 13485 certification project)
  • Implement, if needed, and perform/oversee every critical QA activity including: supplier management, audits, training, deviation & CAPA, complaints, change control, documentation review …
  • Recognize ISO requirements and ensure compliance of Manufacturing, QC, Product Development and Customer Service activities
  • Manage defining, planning, , implementing and continuous improvement of the Quality Management System
  • Build, execute, and support a comprehensive long-term regulatory compliance strategy to meet global market requirements and ensure compliance to all current and future applicable regulations (REACH, RoHS, EMC and Machinery Directives, ...), manage Technical File/CE mark (RUO benchtop instrument)
  • Develop a Risk Management culture at DNA Script, establish and maintain product risk analyses
  • Implement and track critical metrics and KPIs, and flag issues for review/discussion with the QR Director
  • Provide interpretation, leadership, guidance, and recommendations in assessing and resolving Quality & Regulatory issues to ensure product quality and compliance
  • Develop and promote a Quality culture within the company
  • Work in very close collaboration with other stakeholders and promote a positive, inclusive and collaborative working environment within the QR organization, and the rest of the company

Qualifications and experience

Essential

  • Bachelor's degree in life science or engineering required. Advanced educational degree is preferred.
  • 10+ years industry experience in quality, validation, regulatory, risk management, and/or manufacturing with 7+ years of experience in Quality Assurance related field required.
  • Very good knowledge and understanding of ISO 9001/13485, 21CFR820 and/or GMP
  • Excellent communication skills, ability to influence key stakeholders, and drive for decisions and outcomes
  • Successful experiences as a team leader and with cross-functional collaboration
  • Hands-on and results/action-oriented, excel at driving execution, detail oriented,
  • Demonstrated leadership and excellent organizational skills to multi-task in a fast-paced and rapidly changing environment

Desirable

  • Experience in a biotech company
  • Experience managing Regulatory Affairs for RUO products: knowledge of REACH, RoHS, WEE, EMC and Machinery Directives, ...
  • Experience leading Risk Management
  • Experience in project management, and ideally on software and hardware product development projects in life sciences environment

Miscellaneous

  • Job located in South San Francisco
  • Start date: As soon as possible.

Recruitment Process:

  • Initial screening with the hiring manager
  • Day interview at the office (or remote) with the manager, cofounders, HR and the rest of the team
  • Reference Checks
  • Timing: 2-3 weeks

Contact

floriane.cypryk@dnascript.co

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