Roche
Healthcare
AssociateQualityLead(QualityAssurancePrograms)
Neural analysis suggests this role is
optimal for Lead candidates.
“Associate Quality Lead (Quality Assurance Programs) at Roche. Skills: Quality Management System, Regulatory standards, Data analytics, Digital tools. Support design of quality strategies. Support execution of quality strategies”
Industry & Context.
Data interpretation; Actionable quality insights
What They're Looking For.
Must Have
Bachelor's degree scientific or quality-related, 1-3 years' experience, Pharmaceutical, biotech, or medical device industry experience, Foundational understanding of product development, Foundational understanding of GxP regulations, Digital and data literacy, Exceptional organizational skills, Exceptional execution skills, Demonstrated ability to take ownership, Developing expertise in CtQ factors, Developing expertise in functional group operations, Fluency in written and spoken English, Presentation skills
Nice to Have
Experience within GCP, Experience within GVP, Experience within MDR, Ability to interpret data, Ability to translate data into actionable quality insights
What You'll Do.
Support design of quality strategies
Support execution of quality strategies
Support tracking of quality strategies
Execute quality assurance activities
Assess quality assurance status
Generate confidence in systems
Enhance data collection procedures
Perform ad-hoc analyses
Deliver data insights
Present to health authorities
Demonstrate quality strategy implementation
Participate in compliance initiatives
Optimize daily operations
Drive adoption of digital tools
Foster proactive quality culture
Build inclusive work environment
Maintain supportive work environment
Execute departmental goals
Execute departmental initiatives
Utilize AI for audits
Utilize automated tools for audits
Synthesize audit evidence
Provide logistical support for inspections
Provide compliance support for inspections
Scribe duties for inspections
Back-room document QC for inspections
How You'll Work.
Team & Collaboration
Cross-functional teams; Departmental initiatives; Cross-functional initiatives
Communication Scope
Presentation skills
Full Job Description
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. ### ### The Position Are you ready to shape the future of quality management in healthcare? As an Associate Quality Lead within our Pharma Development Quality (PDQ) function, you will play a vital role in supporting the delivery of quality-focused strategies that reinforce trust in our Quality Management System (QMS). Working with a high degree of independence, you will collaborate with cross-functional teams to ensure our clinical and safety data meets rigorous global regulatory standards. In this dynamic position, you will have the unique opportunity to champion a culture of continuous improvement and innovation. By leveraging data analytics and digital tools, you will help optimize data collection and provide key insights that directly support our mission of delivering life-changing medicines to patients faster and more securely. **The Opportunity:** * Implement Quality Strategies: Support the design, execution, and tracking of risk-based quality management strategies across the PDQ portfolio. * Deliver Quality Assurance: Execute targeted activities to assess quality assurance status and generate confidence in our end-to-end systems. * Manage Quality Data: Enhance data collection procedures, perform ad-hoc analyses, and deliver high-quality data insights to fulfil external regulatory needs. * Present to Health Authorities: Demonstrate the effective implementation of quality strategies. * Drive Compliance Projects: Participate in departmental or cross-functional compliance initiatives aimed at optimizing daily o
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