Associate Director/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

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Solid Biosciences is a Charlestown, MA–based precision genetic medicine company focused on developing gene therapies for rare neuromuscular and cardiac diseases. The company advances a portfolio of gene therapy candidates — including SGT-003 for Duchenne muscular dystrophy, SGT-212 for Friedreich’s ataxia, SGT-501 for catecholaminergic polymorphic ventricular tachycardia (CPVT), and SGT-601 for TNNT2-mediated dilated cardiomyopathy — and is developing libraries of genetic regulators and delivery-platform technologies to improve gene therapy delivery. Founded with a patient-focused mission and collaborations across science, technology, and care, Solid emphasizes clinical development, manufacturing infrastructure, and partnerships to bring transformative precision genetic medicines to patients with rare genetic 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 manufacture, 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 compliance • 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 Solid/Supplier meetings and provide input into governance charters • Monitor supplier performance and recommend improvement actions • Lead or support regulatory inspections and manage responses to observations • Serve as QA Lead on cross-functional program teams and contribute to regulatory submission packages • Identify risks, evaluate deficiencies, and collaborate 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 • Collaborate on development and implementation of a quality manual and quality policy

🎯 Requirements

• Bachelor’s degree in a science-related field; experience may substitute for degree • Minimum of ten years of direct technical Quality Assurance experience in the biotech industry for Associate Director; fifteen years for Director • 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, including 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 previous manufacturing/QC operations experience • Strong preference for previous AAV gene therapy experience • Experience with process and analytical technology transfer, including comparability and bridging requirements • Experience bringing a product to commercialization • Regulatory agency inspection direct experience required • Ability and desire to work independently and make decisions with minimal supervision • Strong collaboration, team-building, and organizational skills • Willingness to travel less than 10% for onsite supplier 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, 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 @ Hood Park) • Free Onsite Full-Service Gym (onsite @ Hood Park) • Employee Parking (onsite @ Hood Park) • 12 Observed Holidays and a winter shut down • 15-day PTO Policy and a 80-hour rollover YoY • 40-hour Sick Policy • 8 Hour Floating Holiday