Director/Senior Director, Quality

Sail Biomedicines•Cambridge, MA

About The Position

Sail Biomedicines is pioneering the integrative design and deployment of fully programmable medicines to transform patient care. Sail’s platform combines first-in-class programmable circular RNA technology (Endless RNA™ or eRNA), and an industry-leading platform of programmable nanoparticles, utilizing natural components, to unlock comprehensive programming of medicines for the first time. By leveraging cutting-edge eRNA and nanoparticle deployment technology, Sail is building a wealth of data, enabling unparalleled use of generative AI techniques to identify and design fully programmable medicines that are potent, targeted, versatile, and tunable. Sail was founded by Flagship Pioneering. We are looking for a strategic, execution-focused Head of Quality to oversee and advance our Quality organization. This leader will be responsible for establishing and maturing Sail’s Quality systems and practices across all GxP operations in collaboration with internal stakeholders and external partners. The Head of Quality will own the internal eQMS and be responsible for ensuring GCP, GMP & GPL compliance.

Requirements

15+ years of progressive leadership in biopharmaceutical Quality, including experience supporting global early-stage clinical programs
Deep expertise across both GCP and GMP as well as the supporting Quality Systems, with a track record of successfully leading organizations through regulatory inspections (FDA, EMA, etc.).
Demonstrated success managing external partners (CDMOs, CROs, testing labs).
Strong understanding of regulatory expectations for global post-market quality systems, including complaint management and field alert reporting.
Proven ability to scale Quality organizations and systems to support global operations.
Experience managing an eQMS
Desire to operation in a phase-appropriate, flexible and/or creative manner while ensuring organization wide compliance
Excellent communication, leadership presence, and cross-functional collaboration skills.
Bachelor’s degree in life sciences or related field required; advanced degree preferred.

Responsibilities

Develop and execute Sail’s GxP Quality strategy across pre-clinical and clinical programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH).
Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory, and Clinical leaders to embed Quality into end-to-end business processes.
Serve as the executive Quality representative for regulatory inspections and major health authority interactions.
Manage, execute and maintain critical partner qualification
Lead quality oversight across Sail’s clinical and nonclinical development programs. This includes GCP compliance, CRO/vendor qualification, clinical site audits, TMF management, inspection readiness, and GLP oversight for IND-enabling studies.
Provide quality oversight of the CMC supply chain across internal operations and external CDMOs; ensure compliant batch disposition and vendor compliance.
Ensure compliance with global importation/exporation requirements and maintain oversight of QA and/or QP batch certification and release processes.
Provide strategic oversight for release and stability testing, method validation/transfer, reference standards, and specification lifecycle management.
Quality Management Systems (QMS) ownership: Own and evolve Sail’s QMS, including deviation/CAPA management, change control, documentation, training, and internal/external audit programs.
Establish and oversee global processes for product quality complaints, field alert reporting, investigation closure, and compliance with post-market reporting requirements.
Build and lead a high-performing Quality organization, ensuring clinical and CMC process excellence, regulatory compliance, and a culture of accountability and transparency.
Define and monitor Quality performance metrics, implement continuous improvement initiatives, and ensure systems readiness for global scale.