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