Senior Director, Quality Control

Senior Director, Quality Control - Solid Biosciences

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, including Duchenne muscular dystrophy (Duchenne), Friedreich's ataxia (FA), catecholaminergic polymorphic ventricular tachycardia (CPVT), TNNT2-mediated dilated cardiomyopathy, BAG3-mediated dilated cardiomyopathy, and additional fatal, genetic cardiac diseases. We are advancing a diverse pipeline and delivery platform in the pursuit of uniting experts in science, technology, disease management, and care.

Patient-focused and founded by those directly impacted by Duchenne, Solid's mission is to improve the daily lives of patients living with devastating rare diseases.

We are seeking a Senior Director, Quality Control to lead Solid's QC strategy, including the management of QC activities for clinical programs at CDMOs and external testing labs in support of product manufacturing, release, characterization, and stability of AAV Gene Therapy products. The Senior Director will also provide direct leadership to the QC team. Interfacing closely with the greater Tech Ops and Quality Assurance teams, the Senior Director will provide strategic and tactical support for a growing portfolio of clinical products and eventual commercial product.

The ideal candidate has direct experience in preparation and execution of a QC strategy for registrational stage programs (PPQ/BLA readiness), demonstrated success as a people manager, and a solid technical background, including hands-on experience leading and supporting assay qualification/validation of analytical methods, tech transfer, comparability studies, quality systems, regulatory filings and CMC activities.

This role will report to the Executive Director, Head of Analytical Sciences and will be based in Solid's Corporate Headquarters in Charlestown, MA. The role will work in a hybrid capacity, averaging 2-3 days onsite.

Key Position Responsibilities

* Envision and drive Solid's QC strategy, including the implementation of policies, structures, and methodologies to support late-stage clinical programs

* Lead and oversee QC activities at CDMOs and external testing labs, ensuring the timely execution of release tests to facilitate batch disposition under accelerated timelines

* Lead and develop a team of experienced QC professionals

* Provide QC leadership and support with regulatory submissions (IND/BLA)

* Review SOPs, protocols, reports, impact assessments and root cause analyses

* Oversee laboratory investigations, deviations, change controls, CAPAs, and risk assessments and drive them to successful and timely conclusions

* Oversee the creation of appropriate specifications for excipients, drug substances, and drug products

* Accountable for the continuous improvement of QC systems, such as product specifications, product shelf-life/expiry, reference standard program, stability program, etc.

* Work closely with Analytical Development and Analytical Science & Technology teams to co-lead method transfer, qualification and validation

Experience Requirements

* BS/MS with 15+ years of relevant industrial QC experience with a degree in Biology, Chemistry, Chemical/Biochemical Engineering, or related scientific discipline

* 7+ years of demonstrated people leadership experience within the QC function

* Extensive experience managing CDMOs and Contract Test Labs activities

* Experience authoring and reviewing CMC sections of Regulatory Filings

* Excellent communication skills and ability to build key networks and business relationships across all levels of the business

* Hands-on experience working in a QC lab environment with expert knowledge of both international (e.g. ICH, EU) and national (FDA) quality regulations and guidelines (USP/EP) related to product testing, analytical and stability requirements, validation of analytical methods.

Compensation

The base compensation range for this role is: $245,

Base salary offered is determined through an internal analysis utilizing a combination of factors including, but not limited to, relevant skills & experience, job…