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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
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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
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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.
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