Vaxcyte
Senior Manager, Quality Assurance(m/w/x)
Vollzeitnur vor OrtSenior
Visp
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Developing CMC project timelines and mitigating risks for novel vaccine innovation. Minimum 9 years biotech experience, with 3+ years in CMC, required. Equity component, competitive compensation.
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Anforderungen
- BA/BS degree in life sciences, engineering, or business administration
- Advanced degree desired
- Minimum 9 years pharmaceutical/biotechnology industry experience
- At least 3 years relevant CMC organization experience
- Significant cross-functional team environment experience
- Other education/experience combinations considered
- PMP Certification or Project Management training desired
- Solid understanding of CMC manufacturing and analytical activities
- Knowledge of cGMP regulations
- Previous experience supporting regulatory filings a plus
- Prior experience as liaison with external manufacturing organizations desired
- Expert analytical skills for integrating/interpreting project information
- Strong planning and tracking skills
- Well-organized, results-focused
- Capable of managing multiple projects with respect to priorities
- Self-management skills
- Demonstrated ability to manage complex projects independently
- Ability to manage changes in processes, strategy, and landscape
- Strong team management skills
- Facilitation skills
- Conflict resolution skills
- Team development skills
- Proven influence management skills
- Communication skills at all organization levels
- Working knowledge of MS Word
- Working knowledge of MS Excel
- Working knowledge of MS PowerPoint
- Working knowledge of MS Visio
- Working knowledge of MS Project
- Working knowledge of Veeva a plus
- Working knowledge of Smartsheet a plus
- Excellent written communication skills
- Excellent oral communication skills
Aufgaben
- Develop detailed CMC project timelines
- Identify and mitigate project risks
- Communicate and escalate risks and issues
- Lead CMC cross-functional coordination meetings
- Schedule and facilitate meetings
- Send out meeting agendas
- Write and distribute meeting summaries
- Manage team documentation
- Track goals and action items
- Proactively track operational plans
- Highlight progress towards milestones
- Ensure alignment of task dependencies
- Support process development
- Support analytical development
- Support manufacturing activities
- Support quality assurance
- Support supply chain management
- Operationalize CMC strategy
- Integrate CMC strategy into program schedule
- Communicate project activities and status
- Inform stakeholders of potential risks
- Contribute to cross-functional working plans
- Help prioritize workstreams
- Identify and mitigate risks
- Ensure sufficient resourcing
- Build and manage project trackers
- Create and manage project dashboards
- Communicate real-time project status
- Manage external CMOs
- Develop Statements of Work (SOW) contracts
- Screen and define SOW scope and budget
- Work with internal and external experts
- Track progress of SOW deliverables
- Implement process improvements
- Streamline workflow of CMC teams
Berufserfahrung
9 Jahre
Ausbildung
Abgeschlossene BerufsausbildungODER
Bachelor-AbschlussODER
Master-Abschluss
Sprachen
Englisch – verhandlungssicher
Tools & Technologien
MS WordMS ExcelMS PowerPointMS VisioMS ProjectVeevaSmartsheet
Benefits
Attraktive Vergütung
- Competitive compensation package
- Equity component
Sonstige Vorteile
- Comprehensive benefits
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Vaxcyte erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei VaxcyteÜber das Unternehmen
VA
PharmaceuticalsVisp
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases.
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