Vice President, Quality (San Carlos)
Sutro Biopharma, Inc.
Job Description
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Position Summary:
Sutro Biopharma is seeking a seasoned quality leader for the role of Vice President, Quality, with demonstrated expertise across GMP, GxP, GCP, and GCP regulations, and deep operational knowledge of antibody-drug conjugates (ADCs), biologics, and small molecules. This individual will lead the strategic direction and operational oversight of quality assurance systems across our internal and external contract manufacturing (CMO) partners.
Description
Position Summary:
Sutro Biopharma is seeking a seasoned quality leader for the role of Vice President, Quality, with demonstrated expertise across GMP, GxP, GCP, and GCP regulations, and deep operational knowledge of antibody-drug conjugates (ADCs), biologics, and small molecules. This individual will lead the strategic direction and operational oversight of quality assurance systems across our internal and external contract manufacturing (CMO) partners.
The ideal candidate is an execution-oriented quality executive who thrives in a fast-paced, matrixed environment. This person will be responsible for establishing robust external quality frameworks, ensuring cGMP compliance, and driving vendor quality performance across a global supply network.
Key Responsibilities:
External CMO Quality Management
- Serve as the primary quality interface for all outsourced GMP manufacturing and testing activities.
- Develop and maintain a high-functioning External Quality team accountable for CMO oversight and release.
- Ensure proper execution and monitoring of Quality Agreements with third-party manufacturers and labs.
- Oversee QA support for tech transfer, batch release, investigations, and process validation across external networks.
- Lead and support audits of CMOs, assess gaps and drive remediation and continuous improvement plans.
- Lead global GxP strategy across Sutro’s externalized operations in alignment with FDA, EMA, and ICH expectations.
- Ensure inspection readiness and drive successful outcomes of regulatory inspections involving third-party sites.
- Provide QA leadership for CMO inspections relevant to externally manufactured or tested materials.
- Apply expert knowledge of ADCs, biologics, and small molecule manufacturing quality controls, lifecycle requirements, and regulatory expectations.
- Lead risk assessments and implement controls for modality-specific process and product risks.
- Guide cross-functional teams on analytical, raw material, and release specifications tailored to modality needs.
- Build and manage external quality systems including deviation, CAPA, change control, and batch documentation review.
- Ensure compliant release of clinical and commercial batches, including raw materials, intermediates, and drug products.
- Drive alignment with ERP and electronic quality systems (eQMS) to enable efficient and compliant documentation and data integrity.
- Report to the CTO and collaborate with senior leaders across, regulatory, development, and supply chain.
- Represent Quality in governance discussions with external partners and stakeholders.
- Promote a culture of ownership, compliance, and continuous improvement across Sutro’s external operations.
- Internal: Technical Operations, Quality Control, Regulatory Affairs, Supply Chain, Development, Legal, and Clinical.
- External: Global CMOs, CTOs, raw material suppliers, partner companies, regulatory consultants.
- Education: Bachelor’s degree in a life science discipline required; advanced degree (MS/PhD/PharmD) preferred.
- Experience: 20+ years in Quality roles within the pharmaceutical or biotech industry, including 10+ years leading quality activities at CMOs.
- Proven experience across ADC, biologic, and small molecule manufacturing and testing operations.
- Demonstrated success in managing third-party quality relationships and regulatory inspections (FDA, EMA, etc.).
- Deep understanding of GMP, ICH, and GxP regulations, and ability to train and guide others in these principles.
- Strong decision-making, risk management, and problem-solving skills.
- Excellent communication and stakeholder management ability.
- Willingness to travel ~10% domestically and internationally to support vendor relationships and audit activities.
Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment.
As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together.
To recruiting firms: Sutro Biopharma does not accept agency resumes and solicitations from third-party agencies. Please do not forward resumes to our hiring managers or employees. Sutro Biopharma is not responsible for any fees related to unsolicited resumes.
The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma’s California based locations will be $345,000 - $370,000 (not including bonus, equity, and benefits). The base salary offered will vary depending on the market, job-related knowledge, skills and capabilities, and experience.
About Sutro Biopharma
Sutro Biopharma, Inc., is relentlessly focused on the discovery and development of precisely designed cancer therapeutics to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF, provides the opportunity for broader patient benefit and an improved patient experience. Sutro is advancing a robust early-stage pipeline of novel exatecan and dual-payload antibody drug conjugates (ADCs), coupled with high-value collaborations and industry partnerships, which validate its continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit
Seniority level
Seniority level
Executive
Employment type
Employment type
Full-time
Job function
Job function
Quality Assurance
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Sutro Biopharma, Inc.
San Carlos, CA