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Strategic Quality Partner - Assay and Reagents(m/w/x)
Partnering with Development Project Teams to accelerate milestones and deploy the D&D module. 8+ years in diagnostics industry experience required. Diverse and inclusive workplace, personal expression encouraged.
Requirements
- Bachelor’s degree in science, business, or related field
- MBA or advanced degree preferred
- 8+ years experience in diagnostics industry or related business
- Strong business/financial acumen
- Enterprise mindset
- Solid scientific/technical background with product knowledge
- Infectious disease expertise preferred
- Experience with regulatory requirements and submissions
- FDA / FDA submissions experience
- Knowledge of applicable standards and regulations
- Demonstrated end-to-end experience
- Strong decision-making capability
- Pragmatic, solution-oriented mindset
- Ability to operate without perfect information
- Strong agile knowledge
- Modern ways of working
- Excellent communication skills
- Excellent presentation skills
- Excellent negotiation skills
- Proven leadership experience
- Leading cross-functional and global matrix teams
- Driving change
- Inspiring teams in line with Roche Values
- Ability to influence globally
- Deliver transformative, customer-focused solutions
- Acting according to Roche Operating Principles
- International travel as required
Tasks
- Ensure effective partnerships with Development Project Teams
- Accelerate project milestones and execution
- Drive consistent interpretation and implementation of global requirements
- Deploy and implement the D&D module
- Promote and adopt the Risk Enabler
- Act as single point of contact for project teams
- Lead strategic topics and decisions
- Partner with Design Quality Partners and stakeholders
- Ensure efficient documentation and milestone deliverables
- Incorporate lessons learned into development requirements
- Ensure project plans include D&D module deliverables
- Support internal and external audits
- Facilitate effective milestone reviews
- Promote constructive discussions in project meetings
- Drive risk-based decision making
- Prepare and ensure effective issue resolution
- Develop and enhance playbooks and feedback loops
- Optimize and accelerate Pre-Market Quality contributions
- Embed and improve knowledge management
- Enhance change management and information sharing
- Foster a culture of innovation and continuous improvement
- Act as a role model and coach colleagues
- Drive effective decision-making and complexity reduction
- Promote pragmatic solutions and outcome-focused thinking
- Travel internationally as required
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- ISO 13485
- ISO 14971
- GDP
- GMP
Benefits
Informal Culture
- Diverse and inclusive workplace
- Personal expression encouraged
- Open dialogue encouraged
- Genuine connections fostered
Mentorship & Coaching
- Personal and professional thriving
Not a perfect match?
- Roche Diagnostics Int. AGFull-timeOn-siteSeniorRisch-Rotkreuz
- Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Divisional Strategy Lead(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
People Leader & Assay Architect(m/w/x)
Full-timeOn-siteManagementRisch-Rotkreuz - Roche Diagnostics Int. AG
Senior Engineer - Design Control Excellence(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz
Strategic Quality Partner - Assay and Reagents(m/w/x)
Partnering with Development Project Teams to accelerate milestones and deploy the D&D module. 8+ years in diagnostics industry experience required. Diverse and inclusive workplace, personal expression encouraged.
Requirements
- Bachelor’s degree in science, business, or related field
- MBA or advanced degree preferred
- 8+ years experience in diagnostics industry or related business
- Strong business/financial acumen
- Enterprise mindset
- Solid scientific/technical background with product knowledge
- Infectious disease expertise preferred
- Experience with regulatory requirements and submissions
- FDA / FDA submissions experience
- Knowledge of applicable standards and regulations
- Demonstrated end-to-end experience
- Strong decision-making capability
- Pragmatic, solution-oriented mindset
- Ability to operate without perfect information
- Strong agile knowledge
- Modern ways of working
- Excellent communication skills
- Excellent presentation skills
- Excellent negotiation skills
- Proven leadership experience
- Leading cross-functional and global matrix teams
- Driving change
- Inspiring teams in line with Roche Values
- Ability to influence globally
- Deliver transformative, customer-focused solutions
- Acting according to Roche Operating Principles
- International travel as required
Tasks
- Ensure effective partnerships with Development Project Teams
- Accelerate project milestones and execution
- Drive consistent interpretation and implementation of global requirements
- Deploy and implement the D&D module
- Promote and adopt the Risk Enabler
- Act as single point of contact for project teams
- Lead strategic topics and decisions
- Partner with Design Quality Partners and stakeholders
- Ensure efficient documentation and milestone deliverables
- Incorporate lessons learned into development requirements
- Ensure project plans include D&D module deliverables
- Support internal and external audits
- Facilitate effective milestone reviews
- Promote constructive discussions in project meetings
- Drive risk-based decision making
- Prepare and ensure effective issue resolution
- Develop and enhance playbooks and feedback loops
- Optimize and accelerate Pre-Market Quality contributions
- Embed and improve knowledge management
- Enhance change management and information sharing
- Foster a culture of innovation and continuous improvement
- Act as a role model and coach colleagues
- Drive effective decision-making and complexity reduction
- Promote pragmatic solutions and outcome-focused thinking
- Travel internationally as required
Work Experience
- 8 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Native
- German – Basic
Tools & Technologies
- ISO 13485
- ISO 14971
- GDP
- GMP
Benefits
Informal Culture
- Diverse and inclusive workplace
- Personal expression encouraged
- Open dialogue encouraged
- Genuine connections fostered
Mentorship & Coaching
- Personal and professional thriving
About the Company
Roche Diagnostics Int. AG
Industry
Pharmaceuticals
Description
The company is dedicated to advancing science and ensuring access to healthcare for everyone, with a focus on innovative diagnostics solutions.
Not a perfect match?
- Roche Diagnostics Int. AG
Alliance & Ecosystem Management (AEM) Sub-Chapter Lead(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Regulatory Affairs Project Manager(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
Divisional Strategy Lead(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz - Roche Diagnostics Int. AG
People Leader & Assay Architect(m/w/x)
Full-timeOn-siteManagementRisch-Rotkreuz - Roche Diagnostics Int. AG
Senior Engineer - Design Control Excellence(m/w/x)
Full-timeOn-siteSeniorRisch-Rotkreuz