Associate Director/Director, Technical Quality

About the role

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 an Associate Director/Director of Technical Quality Assurance to provide strategic and operational leadership over external parties for assigned program(s), ensuring compliance with global cGMP, GDP, and regulatory requirements for outsourced manufacturing, analytical testing, packaging, labeling, and distribution activities.

This role will report to the Senior Director, Technical Quality and is flexible to be fully remote within the United States or based out of Solid’s Corporate Headquarters in Charlestown, MA.

Responsibilities

• CDMO/CTL Oversight
  • Negotiate, execute, and provide oversight of relevant Quality Agreements to ensure compliance.
  • Lead Supplier Audits and Qualifications.
  • Provide Quality oversight for processes including technology transfer, CDMO GMP manufacture, CTL testing, and packaging/labeling/distribution of high-quality products for clinical trials and commercialization.
  • Review CDMO manufacturing and testing documentation (batch records, change controls, deviations) to assess completeness, adequacy, and compliance with procedures and regulatory requirements.
  • Oversee and approve lot release and disposition for products and starting materials.
  • Ensure packaging and labeling batch records and execution meet requirements.
  • Manage cold chain and distribution compliance, including temperature excursion management.
  • Implement and lead QP batch certification for EU/UK distribution.
• Quality Systems & Compliance
  • Establish and track Key Quality Indicators for all outsourced activities.
  • Act as QA Lead at joint Solid/Supplier periodic meetings and provide input into governance or other charters.
  • Monitor performance in collaboration with functional colleagues and provide input into actions required for improvement.
  • Act as inspection lead and/or liaison for regulatory inspections specific to the program and manage responses to observations.
  • Serve as QA Lead on cross-functional program teams, providing input for regulatory submission packages (pre-IND, IND, IMPD, CTA, BLA, etc.).
  • Identify risk and evaluate deficiencies, collaborating cross-functionally to remediate risk to an acceptable level.
  • Oversee quality and effectiveness of quality system documents and records (SOPs, change controls, deviations, CAPAs).
  • Lead continuous improvement of the GMP quality management system in collaboration with functional leaders.
  • Promote a company-wide culture of quality and collaborate on the development and implementation of a quality manual and policy.

Requirements

• Bachelor’s degree in a science-related field (experience may substitute for degree).
• Minimum of ten years (Associate Director) or fifteen years (Director) of direct technical Quality Assurance experience in the biotech industry.
• Strong understanding of GMP Quality for starting and critical raw materials, drug substance, drug product, analytical testing, labeling/packaging, and distribution.
• Minimum of three years in a leadership role directly managing outsourced activities (CDMOs/CTLs). Preference for establishment of supplier oversight programs.
• Experience and understanding of Biologics manufacturing processes and analytics at clinical and commercial stages.
• Strong preference for candidates with previous manufacturing/QC operations experience and AAV gene therapy experience.
• Experience with process and analytical tech transfer, including comparability and bridging requirements.
• Experience bringing a product to commercialization.
• Direct experience with regulatory agency inspections is required.

Skills

• Ability and desire to work independently and make decisions with minimal supervision in a fast-paced environment.
• Strong collaboration, team-building, and organizational skills.

Anticipated travel is less than 10% for on-site visits to external suppliers and company meetings.

Pay

The base compensation range for this role is $190,000 – $230,000. Base salary offered is determined through an internal analysis utilizing factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short-term and long-term incentives, including cash bonus and equity opportunities, designed to reward individual performance and align with Solid’s long-term company performance.

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.
• Employee Assistance Programs.
• Daily subsidized lunch delivery (onsite at Hood Park).
• Free onsite full-service gym (onsite at Hood Park).
• Employee parking (onsite at Hood Park).
• 12 observed holidays and a winter shutdown.
• 15-day PTO policy with an 80-hour rollover year-over-year.
• 40-hour sick policy.
• 8-hour floating holiday.