Senior Director, Quality

Description

As the Senior Director, Quality, you will serve as the quality authority for Sagimet Biosciences, leading and building the company's Quality Management System (QMS) and providing oversight of all Manufacturing Quality activities across the clinical and commercial portfolio. You will serve as a key strategic partner to the VP, Technical Operations and collaborate cross-functionally with Manufacturing, Regulatory, Clinical Operations, Supply Chain, and CMC Development teams. This is a high-impact, hands-on leadership role for a quality leader who thrives in a lean, pre-commercial biotech environment and is ready to build scalable quality systems to support the company's path toward commercialization. This role reports to the VP, Technical Operations. 

Requirements

Essential Responsibilities:

Quality Systems & Compliance:

·Own and continuously improve the company's GxP Quality Management System (QMS), ensuring it is fit-for-purpose for to support a commercial product launch.

·Develop, implement, and maintain SOPs, policies, and quality procedures aligned with ICH, FDA, EMA, and GxP guidelines (GCP, GMP, GLP).

·Lead internal quality audits, host regulatory agency inspections, and manage all associated audit responses and CAPAs.

·Oversee deviation management, change control, risk assessment, and CAPA programs.

·Ensure compliance with applicable regulations including 21 CFR Parts 210, 211, 312, and applicable ICH guidelines.

·Drive phase-appropriate quality risk management strategies across all programs and operations.

·Serve as primary quality representative in regulatory body interactions with FDA, EMA, and other agencies as needed.

·Partner with Regulatory to support IND/NDA/BLA filings and CMC sections.

·Maintain the Annual Product Review (APR) / Product Quality Review (PQR) process.

Manufacturing Quality (CMC & Commercial Readiness):

·Provide end-to-end quality oversight of externally executed GxP activities, including drug substance (DS) and drug product (DP) and packaging manufacturing activities to support both clinical and commercial production.

·Manage Quality Agreements with all external manufacturing and testing partners; lead vendor qualification and quality monitoring to ensure partners meet contractual and regulatory quality obligations.

·Provide decision authority on final batch disposition and oversee review and approval of batch records, specifications, test methods, and validation protocols/reports

·Oversee stability programs, raw material qualification, and supplier quality management.

·Support CMC development activities, including process characterization, scale-up, and technology transfer.

·Provide quality support for Phase I, II, and III clinical trial material (CTM) manufacturing and release. 

·Provide quality support for commercial validation and launch activities, including support for NDA preparation, PAI readiness at CMOs and internally (could use some wordsmithing)

·Build and lead commercial-scale quality readiness activities, including commercial GMP infrastructure planning.

Leadership & Cross-Functional Partnership:

·Serve as a key member of the Technical Operations leadership team; partner with VP, Technical Operations on quality strategy, resource planning, and organizational priorities.

·Develop 3 –5 year Quality Plan in alignment with the overall organizational goals, including support for commercial launch.

·Collaborate with Manufacturing, Clinical Operations, Regulatory, Supply Chain, and Program Management to ensure quality is embedded throughout all product development and manufacturing activities.

·Recruit, mentor, and develop quality staff as the organization scales toward commercialization.

·Effectively manage quality-related budgets, timelines, and vendor/CMO relationships.

·Represent quality in cross-functional governance meetings, project teams, and executive/investor discussions as needed.  · ·Communicate quality metrics, KPIs, and risk assessment to senior leadership.

Education and Experience Requirements:

·Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, Biochemistry, or related field); advanced degree (MS, PhD, PharmD) strongly preferred.

·Minimum of 12–15 years of progressive pharmaceutical/biotech quality experience, with at least 5 years in a senior leadership capacity.

·Deep expertise in both Quality Systems/Compliance and Manufacturing Quality (CMC); experience spanning small molecules and/or biologics.

·Demonstrated experience supporting clinical-stage programs (Phase I, II, and/or III) through regulatory submissions (INDs, CTAs, NDAs/BLAs/MAAs).

·Hands-on experience managing CMOs/CDMOs in a quality oversight capacity.

·Strong working knowledge of FDA GMP regulations (21 CFR Parts 210/211) and ICH guidelines (Q7, Q8, Q9, Q10, Q11).

·Experience managing regulatory inspections (FDA, EMA, or equivalent) and leading successful inspection outcomes.

·Proven ability to build and scale quality systems in a lean, resource-constrained environment.

·Excellent communication skills with the ability to translate complex quality and compliance topics for non-technical stakeholders, including executives and Board members.

·Ability to work in a fast-paced, small company environment with multiple competing responsibilities.

·Position involves 10–20% travel.

Preferred Qualifications:

·Experience in both pre-commercial and commercial manufacturing quality environments.

·Exposure to biologics, gene therapy, or cell therapy manufacturing quality.

·Prior experience building a quality organization from the ground up