Associate Director/Director Quality Assurance Department: Regulatory Work Location: Corporate Headquarters (South San Francisco) or Remote Position Summary: TCG Labs-Soleil is looking for a top-notch Associate Director/Director, Quality Assurance to join our team. We are seeking a highly skilled and self-motivated professional to establish and lead our Biosensor Assay Team within the cutting-edge Biologics Technology Group. In this exciting leadership role, you’ll be at the forefront of innovative science as you oversee and shape the biosensor assay capabilities that support a diverse pipleline of protein and antibody-based pre-clinical therapeutics. You’ll collaborate with a talented and interdisciplinary team of scientists across research and early development, driving the technical excellence that will pave the way for future breakthroughs. The Associate Director / Director, Quality Assurance (GMP) is responsible for ensuring the quality and compliance of clinical-stage GMP manufacturing and supply activities in support of early-phase clinical development programs. This role provides quality oversight across GMP operations including batch disposition, documentation review, vendor oversight, and quality system management. The individual will play a key role in maintaining compliance with applicable regulatory requirements (FDA, EMA, ICH) while supporting efficient clinical supply operations. The role requires strong cross-functional collaboration with Manufacturing, CMC, Supply Chain, Regulatory Affairs, and contract manufacturing organizations (CMOs) to ensure the quality and integrity of clinical phase materials. Responsibilities: - Provide QA oversight for GMP manufacturing and clinical supply activities performed by contract manufacturing oranizations. - Perform batch record review and batch disposition for clinical stage GMP materials. - Review and approve executed batch records, analytical reports, and supporting documentation to ensure compliance with GMP requirements. - Manage and review deviations, investigations, CAPAs, and change controls to ensure issues are appropriately documented, investigated, and resolved. - Ensure ongoing GMP compliance across manufacturing, testing, storage, and distribution activities. - Assess and manage temperature excursions and shipping deviations affecting GMP materials. - Author, review, and approve Standard Operating Procedures (SOPs) and other controlled GMP documentation. - Manage document control processes, ensuring GMP documentation is properly maintained and complaint. - Support and oversee GXP training. - Oversee and manage GMP vendors. - Review and approve shelf-life extension justifications and stability-related documentation. Qualifications: - Bachelor’s degree in a scientific discipline (advanced degree preferred). - 8 - 10+ years of experience in GMP Quality Assurance within the pharmaceutical/biotech industry. - Experience supporting early-phase clinical development programs and GMP manufacturing operations. - Strong knowledge of GMP regulations and guidelines (FDA, EMA, ICH). - Experience with batch disposition, deviations, change control, document management, and vendor oversight. - Demonstrated ability to work in a fast-paced, cross-functional environment typical of early-stage companies. - Ability to manage multiple priorities and adapt to changing business needs. Company Overview TCG Labs-Soleil, established in partnership with The Column Group, a science-focused venture capital firm, is pioneering a novel ‘venture capital-biotech’ model. Our core mission is to efficiently translate scientific insights into therapeutic solutions for patients facing serious diseases. This model supports scientific entrepreneurs from the initial idea to clinical proof of concept (PoC) by combining a dedicated fund (TCG Labs) with our independent, evergreen R&D center led by a top-tier scientific team (Soleil). Together, we create an integrated ecosystem that fosters the development of single-asset portfolio companies, strategically poised for transacting after clinical PoC. For more details, visit TCGLSoleil.com and follow us on LinkedIn EEO Statement TCG Labs-Soleil is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws. Any request for accommodation can be directed to contact@tcglsoleil.com. Benefits and Compensation TCG Labs-Soleil provides a competitive benefits package that includes access to Medical, Dental, and Vision Insurance, Life Insurance, Short and Long Term Disability, Health Savings Account (HSA), Flexible Spending Accounts (FSA), 401k plan and PTO. The anticipated salary range for fully qualified candidates applying for this role for an Associate Director will be $154,000 - $275,000 annually and for Director will be $168,000 – 300,000 annually (both levels are not including discretionary bonus, equity, and benefits). The final salary offered will be dependent on several factors that include but are not limited to relevant previous experience including duration and type of experience within the industry, education, and internal equity. Staffing Agencies TCG Labs-Soleil does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with TCG Labs-Soleil. Please do not send agency CVs/resumes through TCG Labs-Soleil website or TCG Labs-Soleil Employees. Inquiries must be sent to contact@tcglsoleil.com with the Subject Heading: Staffing Agency Request.

• Define and scale our automation strategy across the organization. • Balance hands-on technical leadership with strategic governance. • Assess and prescribe automation tools based on product needs. • Design and evolve multi-layer automation frameworks. • Establish coding standards and reusable libraries. • Drive quality-as-code practices and CI/CD integration. • Mentor engineers and enable squads with training.

Company Description When you join Turnitin, you'll be welcomed into a company that is a recognized innovator in global education. For over 25 years, Turnitin has partnered with educators and institutions to develop learning integrity solutions that recognize the enduring value of critical thinking in a rapidly changing world. Over 16,000 academic institutions, publishers, and corporations use our services in more than 185 countries around the world: Turnitin Feedback Studio, Clarity, Originality, Gradescope, ExamSoft, Similarity, and iThenticate. Protecting the value of an authentic education is at the heart of who we are. Experience a remote-first culture that empowers you to work with purpose and accountability in a way that best suits you, supported by a comprehensive package that prioritizes your overall well-being. Our diverse community of colleagues are all unified by a shared desire to make a difference in education. Turnitin is a global organization with team members in over 35 countries including the United States, Mexico, United Kingdom, Australia, Japan, India, and the Philippines. Job Description Quality Engineering plays a crucial role in the software development process. The SEU redteam is primarily responsible for ensuring that software products being developed within the Technology org at Turnitin meet or exceed predetermined quality standards. Responsibilities: - Research: Stay updated on trends and techniques related to unauthorised access to Turnitin; proactively share relevant findings with the team. - Data Analysis: Aggregate, organize, and analyze data to uncover patterns, trends, and vulnerabilities in unauthorized submissions. - Automation & Solution Strategy: Identify areas where developers should focus on improving security. Where possible develop automated test coverage to protect from regressions. - Team Collaboration: Act as a central communication point between technical and non-technical team members to ensure alignment and information flow. - Documentation & Process Improvement: Create, maintain, and regularly update clear documentation and reports covering methods, tools, test strategies, vulnerabilities, and impact assessments; continuously improve related processes to meet evolving needs. - Knowledge Sharing: Provide guidance and occasional training to team members on recognizing and responding to new misuse techniques. - Writing basic automations for regression testing. Qualifications Requirements: - Strong analytical mindset with the ability to identify behavioural patterns, anomalies, and coordinated misuse activity across large datasets. - Experience reviewing structured data (SQL, dashboards, spreadsheets) to investigate incidents and form evidence-based conclusions. - Comfort working with ambiguity and incomplete information; able to form hypotheses and iteratively validate them. - Clear written communication skills, with the ability to summarise findings and propose actionable detection strategies to technical teams. - Ability to document investigation methodologies, emerging misuse techniques, and pattern definitions in a structured, repeatable way. - Strong attention to detail when reviewing logs, submission metadata, account creation behaviour, and other platform signals. - Experience collaborating with engineering, product, and support teams to translate investigative findings into detection rules or operational controls. Nice to Have: - 2-3 years of experience in Education Technology or Saas industries within trust & safety, red teaming, fraud detection, platform abuse investigation, or content integrity space. - Exposure to behavioural analytics or anomaly detection methodologies. - Experience working with customer support teams on high-volume enforcement environments. - Understanding of common evasion techniques (account farming, IP rotation, automation, coordinated misuse networks). - Basic scripting ability (e.g., Python) to support data exploration or pattern validation. Additional Information The expected annual base salary range for this position is: $75,375/year to $125,625/year. This position is bonus eligible / commission-based. Actual compensation will be provided in writing at the time of offer, if extended, and is determined by work location and a range of other relevant factors, including but not limited to: experience, skills, degrees, licensures, certifications, and other job-related factors. Internal equity, market and organizational factors are also considered. Total Rewards @ Turnitin At Turnitin, we believe Total Rewards go far beyond pay. While salary, bonus, or commission are important, they’re only part of the value you receive in exchange for your work. Beyond compensation, you’ll experience the intrinsic rewards of unleashing your potential and making a positive impact on global education. You’ll also thrive in a culture free of politics, surrounded by humble, inclusive, and collaborative teammates. In addition, our extrinsic rewards include generous time off and health and wellness programs that provide choice, flexibility, and a safety net for life’s challenges. You’ll also enjoy a remote-first culture that empowers you to work with purpose and accountability in the way that suits you best, all supported by a comprehensive package that prioritizes your overall well-being. Our Mission is to ensure the integrity of global education and meaningfully improve learning outcomes. Our Values underpin everything we do. - Customer Centric: Our mission is focused on improving learning outcomes; we do this by putting educators and learners at the center of everything we do. - Passion for Learning: We are committed to our own learning and growth internally. And we support education and learning around the globe. - Integrity: Integrity is the heartbeat of Turnitin—it is the core of our products, the way we treat each other, and how we work with our customers and vendors. - Action & Ownership: We have a bias for action. We act like owners. We are willing to change even when it’s hard. - One Team: We strive to break down silos, collaborate effectively, and celebrate each others' successes. - Global Mindset: We consider different perspectives and celebrate diversity. We are one team. The work we do has an impact on the world. Global Benefits - Remote First Culture - Health Care Coverage - Education Reimbursement*Competitive Paid Time Off - Self-Care Days - National Holidays - 2 Founder Days + Juneteenth Observed - Paid Volunteer Time Off - Charitable Contribution Match - Monthly Wellness or Home Office Reimbursement - Access to Employee Assistance Program (mental health platform) - Parental Leave - Retirement Plan with match/contribution Seeing Beyond the Job Ad At Turnitin, we recognize it’s unrealistic for candidates to fulfill 100% of the criteria in a job ad. We encourage you to apply if you meet the majority of the requirements because we know that skills evolve over time. If you’re willing to learn and unleash your potential alongside us, join our team! Turnitin, LLC is an Equal Opportunity Employer- vets/disabled.

Company Description When you join Turnitin, you'll be welcomed into a company that is a recognized innovator in global education. For over 25 years, Turnitin has partnered with educators and institutions to develop learning integrity solutions that recognize the enduring value of critical thinking in a rapidly changing world. Over 16,000 academic institutions, publishers, and corporations use our services in more than 185 countries around the world: Turnitin Feedback Studio, Clarity, Originality, Gradescope, ExamSoft, Similarity, and iThenticate. Protecting the value of an authentic education is at the heart of who we are. Experience a remote-first culture that empowers you to work with purpose and accountability in a way that best suits you, supported by a comprehensive package that prioritizes your overall well-being. Our diverse community of colleagues are all unified by a shared desire to make a difference in education. Turnitin is a global organization with team members in over 35 countries including the United States, Mexico, United Kingdom, Australia, Japan, India, and the Philippines. Job Description Quality Engineering plays a crucial role in the software development process. The SEU redteam is primarily responsible for ensuring that software products being developed within the Technology org at Turnitin meet or exceed predetermined quality standards. Responsibilities: - Research: Stay updated on trends and techniques related to unauthorised access to Turnitin; proactively share relevant findings with the team. - Data Analysis: Aggregate, organize, and analyze data to uncover patterns, trends, and vulnerabilities in unauthorized submissions. - Automation & Solution Strategy: Identify areas where developers should focus on improving security. Where possible develop automated test coverage to protect from regressions. - Team Collaboration: Act as a central communication point between technical and non-technical team members to ensure alignment and information flow. - Documentation & Process Improvement: Create, maintain, and regularly update clear documentation and reports covering methods, tools, test strategies, vulnerabilities, and impact assessments; continuously improve related processes to meet evolving needs. - Knowledge Sharing: Provide guidance and occasional training to team members on recognizing and responding to new misuse techniques. - Writing basic automations for regression testing. Qualifications Requirements: - Strong analytical mindset with the ability to identify behavioural patterns, anomalies, and coordinated misuse activity across large datasets. - Experience reviewing structured data (SQL, dashboards, spreadsheets) to investigate incidents and form evidence-based conclusions. - Comfort working with ambiguity and incomplete information; able to form hypotheses and iteratively validate them. - Clear written communication skills, with the ability to summarise findings and propose actionable detection strategies to technical teams. - Ability to document investigation methodologies, emerging misuse techniques, and pattern definitions in a structured, repeatable way. - Strong attention to detail when reviewing logs, submission metadata, account creation behaviour, and other platform signals. - Experience collaborating with engineering, product, and support teams to translate investigative findings into detection rules or operational controls. Nice to Have: - 2-3 years of experience in Education Technology or Saas industries within trust & safety, red teaming, fraud detection, platform abuse investigation, or content integrity space. - Exposure to behavioural analytics or anomaly detection methodologies. - Experience working with customer support teams on high-volume enforcement environments. - Understanding of common evasion techniques (account farming, IP rotation, automation, coordinated misuse networks). - Basic scripting ability (e.g., Python) to support data exploration or pattern validation. Additional Information The expected annual base salary range for this position is: $75,375/year to $125,625/year. This position is bonus eligible / commission-based. Actual compensation will be provided in writing at the time of offer, if extended, and is determined by work location and a range of other relevant factors, including but not limited to: experience, skills, degrees, licensures, certifications, and other job-related factors. Internal equity, market and organizational factors are also considered. Total Rewards @ Turnitin At Turnitin, we believe Total Rewards go far beyond pay. While salary, bonus, or commission are important, they’re only part of the value you receive in exchange for your work. Beyond compensation, you’ll experience the intrinsic rewards of unleashing your potential and making a positive impact on global education. You’ll also thrive in a culture free of politics, surrounded by humble, inclusive, and collaborative teammates. In addition, our extrinsic rewards include generous time off and health and wellness programs that provide choice, flexibility, and a safety net for life’s challenges. You’ll also enjoy a remote-first culture that empowers you to work with purpose and accountability in the way that suits you best, all supported by a comprehensive package that prioritizes your overall well-being. Our Mission is to ensure the integrity of global education and meaningfully improve learning outcomes. Our Values underpin everything we do. - Customer Centric: Our mission is focused on improving learning outcomes; we do this by putting educators and learners at the center of everything we do. - Passion for Learning: We are committed to our own learning and growth internally. And we support education and learning around the globe. - Integrity: Integrity is the heartbeat of Turnitin—it is the core of our products, the way we treat each other, and how we work with our customers and vendors. - Action & Ownership: We have a bias for action. We act like owners. We are willing to change even when it’s hard. - One Team: We strive to break down silos, collaborate effectively, and celebrate each others' successes. - Global Mindset: We consider different perspectives and celebrate diversity. We are one team. The work we do has an impact on the world. Global Benefits - Remote First Culture - Health Care Coverage - Education Reimbursement*Competitive Paid Time Off - Self-Care Days - National Holidays - 2 Founder Days + Juneteenth Observed - Paid Volunteer Time Off - Charitable Contribution Match - Monthly Wellness or Home Office Reimbursement - Access to Employee Assistance Program (mental health platform) - Parental Leave - Retirement Plan with match/contribution Seeing Beyond the Job Ad At Turnitin, we recognize it’s unrealistic for candidates to fulfill 100% of the criteria in a job ad. We encourage you to apply if you meet the majority of the requirements because we know that skills evolve over time. If you’re willing to learn and unleash your potential alongside us, join our team! Turnitin, LLC is an Equal Opportunity Employer- vets/disabled.