Digital CMC Consultant – Life Sciences

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QbDVision

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11 - 50 Mitarbeiter

🧬 Biotechnologie

☁️ SaaS

🤝 B2B

Biotechnology • SaaS • B2B

QbDVision ist eine cloud-native Softwareplattform, die digitales Produktlebenszyklus- und CMC- (Chemie, Herstellung und Kontrolle) Management für Biopharma- und Biotech-Unternehmen bietet. Die Plattform zentralisiert Wissen und Daten in einer durchsuchbaren, zentralen Wissensquelle, ermöglicht eine optimierte Prozessentwicklung, bietet Prozessintelligenz für bessere Entscheidungsfindung und vereinfacht den Technologietransfer und die regulatorische Dokumentation. QbDVision richtet sich an Life-Science-Teams und Unternehmen, die die Entwicklung von Arzneimitteln und Biologika durch spezialisierte digitale Workflows und Compliance-orientierte Funktionen modernisieren und beschleunigen möchten.

Beschreibung

• Lead complex workstreams and projects focused on Digital CMC across development and manufacturing, driving business and technology transformations to modernize how life sciences organizations deliver breakthrough therapies • Analyze complex business requirements to document and implement digital CMC projects, ensuring all technical specifications meet client-defined business outcomes • Responsible for execution and delivery on customer projects, providing guidance and best practices, while ensuring our customer’s overall success • Drive the development of Digital CMC thought leadership, helping clients shape their transformation vision and transition from legacy processes to a "to-be" digital enterprise environment • Collaborate with senior stakeholders to define project scopes, align on transformational goals, and ensure buy-in for recommended Digital CMC solutions • Serve as a bridge between clients and internal Product and Engineering teams to ensure customer requirements are accurately documented and understood

🎯 Anforderungen

• Bachelor’s degree in science, business, or equivalent working experience • MEM or 10+ years of direct experience with life sciences, software or consulting in or supporting regulated industry • Pharma background with CMC, QA and/or Regulatory experience/exposure preferred • Familiarity with one or more workflows supporting GMP manufacturing (e.g. supply chain, change management, tech transfer, Validation, etc.) • Strong analytical and problem solving skills • Experience working with global pharmaceutical companies • Customer-facing consulting experience • Managed relationships with executive stakeholders • Ability to travel up to 30%

🏖️ Vorteile

• Our people-first focus: Every company decision is made with you in mind. From our unlimited PTO to flexible work hours, we do our best to prioritize our people by empowering them to work (and live!) in the way that best suits their needs. • Culture of teaching and learning: Growth is the bedrock of success, so we strive for it at every opportunity. • Competitive compensation package: Keeping great talent means knowing someone’s value, and paying them for it. Our salaries, equity offerings, and bonuses reflect the A-players we hire. • Family-Friendly PTO Policies: Unlimited vacation policy is reflective of our family-first culture and to encourage a healthy work-life balance. • Hybrid Office Model: As a virtual company with teammates located around the world, you will have the option to work from home and/or to go into an office (if you are in one of our brick and mortar cities – Austin, Boston, and Dublin). • Commuter Benefits (Dublin, Ireland): We support flexible and cost-effective commuting options through applicable commuter benefit programs and pre-tax savings opportunities, including public transportation and eligible cycling-to-work initiatives. • Stipends: We offer our full-timers various stipends to promote professional growth and allow for success in one’s role. Making you better makes us better!