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Director/Sr. Director of Clinical Quality

Solid Biosciences

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Quality Assurance

Charlestown, Boston, MA, USA

Posted on Tuesday, January 30, 2024

Director/Sr. Director of Clinical Quality

Solid Summary:

Solid Biosciences is a life science company focused on advancing a portfolio of neuromuscular and cardiac programs, including SGT-003, a differentiated gene therapy candidate for the treatment of Duchenne, AVB-401, a gene therapy program for the treatment of BAG3 mediated dilated cardiomyopathy, AVB-202-TT, a gene therapy program for the treatment of Friedreich’s Ataxia, and additional assets for the treatment of fatal cardiac diseases. Solid aims to be the center of excellence across a given disease spectrum bringing together those with expertise in science, technology, disease management, and care. Patient-focused and founded by those directly impacted, Solid’s mandate is to improve the daily lives of patients living with these devastating diseases.

Position Summary:

Solid Biosciences is seeking a Director/Sr. Director of Clinical Quality with experience in quality and regulatory compliance related to preclinical and clinical development and operations, pharmacovigilance, and supplier management. This role can be fully remote or hybrid, based in our office in Charlestown, MA. The Director/Sr. Director of Clinical Quality will:

Provide oversight of GCP and GLP activities, including oversight of contract research organizations (CRO) and clinical sites.
Ensure phase-appropriate Quality procedures are established and maintained.
Oversee GXP supplier qualification and audit.

Essential Functions / Key Responsibilities:

Oversee preclinical and clinical processes and systems.
Review preclinical and clinical program documents (e.g., protocols, reports).
Collaborate with Development, Preclinical, and Clinical teams to maintain training curricula associated with GCP/GLP activities.
Collaborate closely with a small team of Quality colleagues to define and oversee Quality Management System requirements.
Support preparation and review of regulatory agency filings and applications to ensure compliance with regulatory requirements.
Lead clinical quality investigations, including generation and follow-up of deviations and Corrective and Preventative Action (CAPA) plans.
Support regulatory inspection readiness and manage regulatory inspections.
Oversee supplier qualification and audit for all GXP activities/services, including scheduling audits, assigning auditors, and maintaining approved supplier list and associated controlled documents.
Perform GLP and GCP audits, as necessary.
Additional tasks, as assigned.

Basic Qualifications:

Bachelor's degree.
Knowledge and experience with US and EU cGMP regulations and guidance.
Experience interacting with FDA, EMA, and other global health authorities.
Knowledge of GLP and GCP pharmaceutical regulations and current industry practices.
Experience performing GLP and GCP audits.
Experience executing and overseeing quality systems, including supplier qualification and audit, quality events, and CAPA.
Ability and desire to work in a fast-paced clinical phase environment.
Strong collaboration, team-building, and organizational skills

Years of Experience:

Eight or more years' experience in biotechnology or pharmaceutical industry, including five or more years of GCP Quality experience.

Preferred Qualifications:

Gene therapy experience.
Experience establishing and maintaining Phase I/II quality system requirements.

Travel Commitment:

10%- Occasional trips to conduct onsite audits or to Solid’s office in Charlestown, MA.

This job is no longer accepting applications

See open jobs at Solid Biosciences.See open jobs similar to "Director/Sr. Director of Clinical Quality" Foresite Capital LP.

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