Roche
HeadofQuality
“Head of Quality at Roche. Skills: Quality, Compliance, Regulatory, Validation. Ensure manufactured products meet Health Authority regulations. Establish and support inspection readiness”
What You'll Achieve.
Achieve organizational goals; Achieve departmental goals; Achieve long-term goals; Achieve employee personal growth; Achieve employee professional growth; Double patient access to novel, high-medical-value diagnostics; Build the leading, profitable insights; Improve patients’ lives via ‘One Roche Approach’; Build the leading ecosystem in every country
What They're Looking For.
Must Have
At least ten (10) years in the Medical Device/Pharmaiopharmaceutical industry with 5 years working in Quality, Compliance, Regulatory and/or Validation, Excellent knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards, Demonstrated experience in Health Authority inspections, Demonstrated experience leading multi-jurisdictional audits and regulatory mappings for global facility convergence
What You'll Do.
Ensure manufactured products meet Health Authority regulations
Establish and support inspection readiness
Prepare responses to inspection observations
Implement corrections for inspection observations
Ensure Product Quality is our focus
Deliver high quality products
Ensure our right to operate
Provide leadership and guidance to staff
Manage performance and development of direct reports
Maintain an effective Quality governance
Improve governance to meet business needs
Communicate quality or regulatory issues
Develop annual budget
Revise forecasts to meet business needs
Monitor/control expenditures
Ensure site’s technical documentation is maintained
Ensure quality management systems are maintained
Ensure regulatory filings are maintained
Partner with Operations Site Head
Improve working effectiveness
Resolve escalated bottlenecks
Resolve escalated dependencies
Build and maintain partnerships with leaders
Assure alignment around strategic projects
Assure alignment around day-to-day activities
Coordinate with Functional Partners
Aggregate upcoming LCTs’ needs
Aggregate upcoming priorities
Understand upcoming resource demands
Develop organizational strategies
Communicate organizational strategies
Ensure GMP compliance of the site
Ensure continuous improvements
Achieve long-term goals
Negotiate with Senior Leadership
Influence decision making
Lead the organization
Coach the organization
Guide the organization
Manage performance of Quality Unit members
Develop members of Quality Unit
Achieve organizational goals
Achieve employee personal growth
Achieve employee professional growth
Build a pipeline of talent
Build robust succession plans
Manage people processes
Administer people processes
Provide training of personnel
Champion Engrained Quality at the Site
Advocate for Engrained Quality at the Site
Build a culture of continuous improvement
Model lean leadership principles
Ensure organization seeks voice of customer
Consider voice of customer in priorities
Consider voice of customer in outputs
Act as role model for Agile Leadership behaviors
Act as role model for culture
Act as role model for mindset
Act as role model for behaviors
Model behaviors for transformation to Agile Ways of Working
Contribute to Roche Ten Year ambitions
How You'll Work.
Team & Collaboration
Cross-functional coordination; Work with chapters; Work with Network Leads; Collaboration with other Networks Leaders; Collaboration with stakeholders; Build and maintain partnerships with site leaders; Build and maintain partnerships with network leaders; Coordinate with Functional Partners
Communication Scope
Open dialogue; Communicate significant quality or regulatory issues; Communicate significant risks; Communicate organizational strategies
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