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Director/ Senior Director, Quality Assurance and Regulatory Affairs 72 views

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Ginkgo Bioworks is a publicly traded (NYSE: $DNA), high-growth biotechnology company based in Boston’s Seaport District, that is redesigning the living world to solve some of the globe’s growing challenges in health, energy, food, material, and more. Our mission to “make biology easier to engineer” is poised to disrupt multiple industries by leveraging our innovative data, automation, and scale capabilities in biological engineering. 
In response to the global COVID-19 pandemic, we have launched a new division: Concentric by Ginkgo. We firmly believe that testing is an essential requirement to re-open the economy as quickly and safely as possible. Concentric is the largest provider of K-12 COVID-19 testing. We currently run state-level K-12 testing programs in more than 10 states and some of the nation’s largest school districts. To date, Concentric has sequenced more than 10,000 samples from a variety of sample types, in support of public health. As we continue to scale Concentric by Ginkgo, our work is also evolving and expanding into new and exciting directions.
The Director/ Senior Director of Quality Assurance and Regulatory Affairs will partner with internal cross-functional stakeholders to deliver quality and regulatory solutions that enable Concentric to meet business needs and US safety, quality and regulatory requirements. This person will support commercialization of products and services globally. This role will collaborate with peers and senior leaders across the biosecurity business unit to solve varied, complex and novel issues, typically working with greater discretion and latitude. The role requires broad expert knowledge and experience in quality, regulatory and biotechnology businesses, and strong strategic, collaboration and communication skills, as well as an agile mindset, to evolve the way we deliver solutions

Responsibilities

  • Serve as the primary Quality and Regulatory Affairs adviser for the promotion and commercialization of Concentric products and services. Key activities may include, but are not limited to:
  • Serve as regulatory approval for quality, technical and/or safety communications.
  • Identify and mitigate quality and regulatory risks in collaboration with stakeholders. Manage quality systems, and inform senior leadership in compliance with quality system requirements. May conduct or support quality and regulatory audits, monitoring and/or inspections.
  • Support implementation and continuous improvement of quality system policies and procedures, including delivery of training, to meet best practice standards and/or improve quality and the user experience for clients and end-users.
  • Collaborate with internal partners, including the Legal team, to provide actionable and strategic advice for business and operations teams.
  • Provide advice to clients working with and developing products for surveillance, diagnostics, and CLIA labs. Participate with leadership in setting strategic direction and developing the capabilities of the QA/RA team.
  • As assigned, lead or otherwise participate in special projects and act as a standing or ad hoc member of other teams
  • Minimum Requirements

  • Bachelors degree and 10+ years of related experience
  • Highest level of knowledge of industry quality and regulatory standards and processes, particularly in FDA-regulated environments
  • High level of knowledge of business operations, objectives and strategies
  • High learning agility
  • Excellent problem-solving and decision-making skills. Applies risk-based problem solving and appropriate business solutions to effectively mitigate compliance risk. 
  • Experience with cross-functional problem solving and driving change through to successful implementation. 
  • Effective in assessment of compliance risks and the ability to communicate potential business impact.
  • Excellent influencing skills. Proven track record and experience in building and cultivating relationships with key partners and stakeholders across organizational levels. Excellent client service, negotiation, leadership, and communication skills.
  • Strong process-orientation with proven effectiveness in identifying, developing and implementing scalable/sustainable processes and other continuous improvements to achieve organizational efficiencies and increase effectiveness.
  • Proven ability to work autonomously
  • Preferred Capabilities and Experience

  • Bachelor’s degree in life sciences or business
  • 10+ years of experience supporting biotechnology or life sciences companies in FDA and related regulated fields
  • Technical knowledge of products to be supported
  • Industry experience with advertising and promotional communications approval process
  • Experience managing Corrective and Preventive Action (CAPA) activities
  • Experience in performing and responding to audits, inspections and risk assessments
  • Note on culture: Concentric by Ginkgo is a high energy, positive and fast paced environment where new challenges and opportunities arise every day, so this opportunity is ideal for people who thrive in those kinds of environments, and for people who like lots of variety in their day. There are lots of opportunities to learn and grow. The team is motivated by doing high impact work in service to society. To get a sense of the culture at Ginkgo, read some articles in Grow by Ginkgo, the company magazine we produce, which tells the story of synthetic biology in a Ginkgo-authentic way.
    To learn more about Ginkgo, check out some recent press:
    We also feel that it’s important to point out the obvious here – there’s a serious lack of diversity in our industry, and that needs to change. Our goal is to help drive that change. Ginkgo is deeply committed to diversity, equity, and inclusion in all of its practices, especially when it comes to growing our team. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life.  
    We’re developing a powerful biological engineering platform, so we must remain mindful of the many ways our technology can – and will – impact people around the world. We care about how our platform is used, and having a diverse team to build it gives us the best chance that it’s something we’ll be proud of as it continues to grow. Therefore, it’s critical that we incorporate the diverse voices and visions of all those who play a role in the future of biology.
    It is the policy of Ginkgo Bioworks to provide equal employment opportunities to all employees and employment applicants.

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    Company Information
    • Active Jobs 101 Jobs
    • Company Address 27 Drydock Avenue, 8th Floor Boston, MA 02210
    • City Boston
    • Location Massachusetts
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