Director/ Senior Director
Quality Assurance and Regulatory Affairs
Posted on 6/17/2022
INACTIVE
Ginkgo Bioworks

1,001-5,000 employees

Engineering biology for diverse commercial applications.
Company Overview
Ginkgo Bioworks, Inc. stands out as a leading bioengineering company that leverages advanced biological manufacturing technology to design and optimize a wide range of commercial products, from vaccines to sustainable fashion materials. The company's commitment to diversity, equity, and inclusion (DEI) fosters a unique and inclusive culture, promoting a diverse workforce that contributes to its success. Furthermore, Ginkgo's ability to engineer biology for equitable distribution of benefits positions it as a key player in various industries, including healthcare, agriculture, and fashion.
Consumer Goods
Food & Agriculture
Biotechnology

Company Stage

N/A

Total Funding

$2.4B

Founded

2009

Headquarters

Boston, Massachusetts

Growth & Insights
Headcount

6 month growth

6%

1 year growth

7%

2 year growth

61%
Locations
Remote
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Communications
Quality Assurance (QA)
CategoriesNew
QA & Testing
Requirements
  • Bachelor's degree and 10+ years of related experience
  • Strong knowledge of quality and regulatory standards pertaining to surveillance testing, approved diagnostics, and sample collection kits
  • 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 regulatory and quality 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
Responsibilities
  • 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 regulatory and 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 subject matter experts and 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
Desired Qualifications
  • Degree in life sciences or business
  • Experience supporting biotechnology or life sciences companies in quality and regulatory compliance
  • Sufficient scientific background to support quality assessments of diagnostic and surveillance tests
  • 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
  • Understanding of FDA and global regulatory requirements and ability to advise the business on implementation of compliant testing