QA Investigator, Principal Technical Mgr
Roche - San Francisco, CA

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QA Investigator, Principal Technical Manager

Main Purpose of the Position:
• Manage and lead complex multi-site investigations following cGMP regulations and Genentech company standards
• Lead cross functional teams to develop and deliver solutions to complex discrepancy management issues
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address unusually, broad range, complex investigations.
Job Duties/Responsibilities:
• Follow company policies and procedures
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
• Set personal performance goals and collaborate with management to establish
• Organizational objectives.
• Perform tasks and work to achieve company goals and organizational objectives.
• Prioritize workload to meet department and organizational targets and timelines.
• Manage competing priorities and allocate, adjust, and optimize assigned department resources.
• Manage or participate as the Quality representative on cross-functional teams or initiatives.
• Identify, design, and implement process and system improvements..
• Maintain accountability for deliverables affecting department and organizational objectives.
• Serve as a technical subject matter expert (SME) in support of departmental functions.
• Mentor junior personnel serving as a subject matter expert (SME) on Quality systems, processes, and issues.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors as described in Roche’s Leadership competencies
Technical Duties/Responsibilities:
• Manage the end-to-end investigation process.
• Ensure investigation action plan, action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards.
• Collaborate with internal departments and across sites to ensure understanding and execution of Quality Investigations and CAPA systems, processes, policies and procedures.
• Identify and ensure investigation reports are reviewed and approved by appropriate levels of Management.
• Review and approve investigation reports and supporting documentation.
• Identify, facilitate and establish cross-site and cross-business unit processes to ensure efficient and timely investigation strategies.
• Provide final product disposition recommendations that may be affected by deviations or discrepancies to Senior Management.
• Ensure appropriate application and integration of cGMPs into the discrepancy management system.
• Educate departments on the best practices for conducting investigations and root cause analysis.
• Provide guidance to Quality Investigation staff on developing compliant Quality Investigations and CAPAs.
• Lead cross-functional teams to resolve deficiencies identified through the root cause analysis process.
• Lead or participate in root cause analysis.
• Perform timely escalation to Sr. Management of quality issues potentially impacting products, materials or processes.
• Develop and administer a system for tracking and trending of discrepancy investigations and associated Corrective and Preventive Actions (CAPA).
• Present investigation reports, discrepancy management rationale, and CAPAs during periodic audits and Health Authority inspections.
• Participate in internal and vendor audits.
• Communicate group performance against established metrics to Quality Management.
• Ensure adequate resources are identified and allocated to perform department functions.
• Collaborate with departments to ensure process improvement proposals are practical and feasible.
Who you are In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel medicines to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.

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Roche is an Equal Opportunity Employer

About this company
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Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...