Director/Sr. Director of Quality Assurance - GxP  
June 2025

Department: Corporate
Work Location:  Corporate Headquarters (South San Francisco)

Position Summary:

TCG Labs-Soleil is looking for a Director / Senior Director of Quality Assurance who will report to the VP of Regulatory Affairs. This individual will build, lead, and execute our GxP Quality Assurance strategy. This is a rare opportunity to help shape the quality culture and systems from the ground up in a fast-paced, science-driven environment.
The Director/Senior Director of Quality Assurance will be a key member of the leadership team, responsible for developing, implementing, and maintaining the Quality Assurance function across GxP areas (GLP, GCP, GMP) to ensure compliance with regulatory requirements and industry best practices. This role will play a critical role in supporting clinical and manufacturing programs, ensuring quality is embedded in our processes from the ground up.

Key Responsibilities

1. Quality Leadership & Strategy

  • Serve as the primary quality leader across GxP functions (GLP, GCP, GMP).
  • Develop and execute a scalable GxP Quality Assurance strategy aligned with company goals and regulatory expectations.
  • Provide guidance to management on quality risks and mitigation strategies.
  • Foster a proactive quality culture rooted in continuous improvement, compliance, and operational excellence.
  • Has a pragmatic and agile mindset with a risk-based approach to developing solutions based on fit-for-purpose development.

2. Quality Systems Development and Compliance

  • Build, implement, and maintain a phase-appropriate Quality Management System (QMS) to support GLP, GCP, and GMP compliance.
  • Author and implement SOPs and policies supporting clinical development, CMC activities, and external partnerships.
  • Oversee document control, training, deviation management, CAPA, change control, and audit readiness.
  • Ensure compliance with FDA, EMA, and other global health authority regulations.
  • Oversee QA activities related to manufacturing, reviews executed batch records, manufacturing data and test results for accuracy, completeness and compliance
  • Responsible for batch release and disposition
  • Oversee QA activities related to clinical trials, including protocol adherence, data integrity and informed consent

3. Vendor and Partner Oversight

  • Conduct qualification, auditing and oversight of CROs, CDMOs, testing labs, suppliers and other third-party GxP contract service providers.
  • Ensure quality agreements are in place and compliance is monitored.

4. Cross-functional Collaboration

  • Partners with Clinical, Regulatory, CMC, nonclinical, supply chain team members to ensure quality is integrated throughout the development lifecycle.
  • Serve as QA representative on development teams and governance bodies.

Qualifications 

  • Bachelor’s degree in scientific or technical discipline; advanced degree preferred.
  • Minimum 12+ years of experience in Quality Assurance in the biotech/pharmaceutical industry, with at least 5+ years in a leadership role.
  • Strong knowledge of global GxP regulations and guidance, including FDA, EMA, and ICH requirements and global regulatory expectations
  • Experience in building QA functions and systems in an early-stage or growth-stage biotech environment.
  • Proven ability to lead audits and manage external QA vendors.
  • Ability to work in a fast-paced, dynamic, and collaborative environment.
  • Excellent leadership, communication, and problem-solving skills.

Additional Requirements

  • Willingness to travel for site visits and audits


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 the Director role is $168,000 - $300,000 annually and for the Sr. Director role is $199,500 - $356,250 annually (both roles 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.  

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