Associate Director – Technical Quality

🔥 0 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $190k - $230k / year

⏰ Full Time

🟠 Senior

👔 Director

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Solid Biosciences

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2013

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Solid Biosciences is a precision genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases, such as Duchenne muscular dystrophy and Friedreich’s ataxia. Founded by individuals directly impacted by these conditions, Solid aims to improve the lives of patients through innovative treatments and technologies. The company collaborates with experts in science and healthcare to develop therapies that address significant unmet medical needs in rare diseases.

📋 Description

• Provide strategic and operational leadership over external parties for assigned programs • Ensure outsourced manufacturing, analytical testing, packaging, labeling, and distribution comply with global cGMP, GDP, and regulatory requirements • Negotiate, execute, and oversee Quality Agreements • Lead supplier audits and qualifications • Provide quality oversight for technology transfer, CDMO GMP manufacturing, CTL testing, and clinical-trial product packaging, labeling, and distribution • Review CDMO manufacturing and testing documentation, including batch records, change controls, and deviations • Oversee and approve lot release and disposition for products and starting materials • Oversee packaging and labeling execution • Manage cold-chain and distribution compliance, including temperature excursions • Implement and lead QP batch certification for EU/UK distribution • Establish and track Key Quality Indicators for outsourced activities • Act as QA Lead at joint company/supplier meetings and contribute to governance charters • Monitor supplier performance and recommend improvement actions • Lead or support regulatory inspections and manage responses to observations • Act as QA Lead on cross-functional program teams and contribute to regulatory submission packages • Identify risks and evaluate deficiencies, collaborating cross-functionally on remediation • Oversee quality-system documents and records, including SOPs, change controls, deviations, and CAPAs • Lead continuous improvement of the GMP quality management system • Promote a company-wide quality culture and collaborate on the quality manual and policy • Report to the Senior Director, Technical Quality

🎯 Requirements

• Bachelor’s degree in a science-related field; experience may substitute for the degree • Minimum 10 years of direct technical Quality Assurance experience in biotech for Associate Director, or 15 years for Director • Strong understanding of GMP quality for raw materials, drug substance, drug product, analytical testing, labeling, packaging, and distribution • Minimum 3 years in a leadership role directly managing outsourced activities, including CDMOs and CTLs • Experience establishing supplier oversight programs preferred • Experience with biologics manufacturing processes and analytics at clinical and commercial stages • Previous manufacturing/QC operations experience strongly preferred • Previous AAV gene therapy experience strongly preferred • Experience with process and analytical technology transfer, including comparability and bridging requirements • Experience bringing a product to commercialization • Direct regulatory agency inspection experience required • Ability to work independently and make decisions with minimal supervision • Strong collaboration, team-building, and organizational skills • Willingness to travel less than 10% for supplier site visits and company meetings

🏖️ Benefits

• Short-term and long-term incentives, including cash bonus and equity incentive opportunities • Competitive health and dental programs with flexible plan offerings • FSA and HSA programs • 401(k) program with competitive company matched contributions • 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 @ Hood Park) • Free onsite full-service gym (onsite @ Hood Park) • Employee parking (onsite @ Hood Park) • 12 observed holidays and a winter shutdown • 15-day PTO policy and an 80-hour rollover year over year • 40-hour sick policy • 8-hour floating holiday