Senior Director, Quality Control

Solid Biosciences • Boston, MA

7d • Hybrid

About The Position

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac 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.

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.

Nice To Haves

• Preparation and execution of a QC strategy for registrational stage programs (PPQ/BLA readiness)
• Demonstrated success as a people manager
• 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.

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

Benefits

• Competitive Health and Dental programs with flexible plan offerings, including FSA and HSA programs
• 401(k) program participation with competitive company matched contributions
• Eligibility to participate in Solid’s Employee Stock Purchase Plan
• Mobile phone subsidy for eligible employees
• Tuition Reimbursement
• Vision Coverage
• Life Insurance
• Voluntary Pet Insurance
• Employee Discount Program on Travel, Entertainment, and Services
• Daily Subsidized Lunch Delivery (onsite @ Hood Park)
• Free Onsite Full-Service Gym (onsite @ Hood Park)
• Employee Parking (onsite @ Hood Park)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior