Associate Director/Director, Technical Quality

🕒 il y a 1 mois

🍂 Massachusetts – Distant

🍂 Massachusetts – Remote

💵 $190 000 - $230 000 / an

⏰ Temps Plein

🟠 Senior

👔 Directeur

👻 Score fantôme 3%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Solid Biosciences

Site WebLinkedInTous les Emplois

51 - 200 employés

Fondée en 2013

🧬 Biotechnologie

💊 Pharmaceutique

Biotechnology • Pharmaceuticals

Solid Biosciences est une entreprise de médecine génétique de précision basée à Charlestown, MA, spécialisée dans le développement de thérapies géniques pour les maladies neuromusculaires et cardiaques rares. L'entreprise avance un portefeuille de candidats à la thérapie génique, incluant le SGT-003 pour la dystrophie musculaire de Duchenne, le SGT-212 pour l'ataxie de Friedreich, le SGT-501 pour la tachycardie ventriculaire polymorphique catécholaminergique (TVPC), et le SGT-601 pour la cardiomyopathie dilatée médiée par TNNT2. Elle développe également des bibliothèques de régulateurs génétiques et de technologies de plateforme de livraison pour améliorer la distribution de thérapies géniques. Fondée avec une mission centrée sur les patients et des collaborations à travers la science, la technologie et les soins, Solid met l'accent sur le développement clinique, l'infrastructure de production, et les partenariats pour apporter des médicaments génétiques de précision transformateurs aux patients atteints de maladies génétiques rares.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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