Associate Director / Director, Quality Assurance

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.