Senior Technical Manager resume example

Job Responsibilities:

• Lead all product complaint investigations (critical and non-critical) with minimal guidance and ensure investigation action plans and final investigation summaries are accurate, include appropriate corrective actions, and follow company standards. Collaborate with departments (e.g. Affiliates, Manufacturing/Packaging Sites, External Quality) to establish appropriate, efficient, and timely.investigation strategies.

• Lead root cause analysis and present at QRB.

• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.

• Develop solutions to complex product complaint issues and Quality initiatives with inter-organizational impact following cGMP regulations and Genentech standards.

• Ensure appropriate application & integration of cGMPs in the product complaints management system.

• Draft personal performance accountabilities and provide input to departmental objectives.

• Draft personal development plan and work with department manager to determine development activities for the calendar year.

• Establish work priorities to meet targets and timelines and effectively manage competing priorities, with minimal escalation.

• Serve as the Quality representative on cross-functional and.multi-site teams.

• Identify, design, and implement department or cross-functional business process improvements.

• Analyze complaint information and identify potential Quality issues including performing trend analysis.

Collaborate with key stakeholders to foster effective interdepartmental and cross-functional partnership solutions.

• Develop, train, and mentor personnel and internal customers on relevant business processes.

• Collaborate and influence department procedures (e.g. SOPs, FNs, etc ...).

• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.

• Inform management of critical product complaints and provide timelY impact assessments of potentially affected products, materials or processes.

• Review and approve product complaint investigation reports and supporting documentation.

• Educate departments on the best practices for conducting investigations and root cause analysis.

• Lead department project teams to resolve product complaint process deficiencies identified.

• Assess the accuracy of root cause determinations based on a thorough evaluation of possible failure modes.

• Present product complaint records and/or reports during periodic audits and regulatory inspections.

• Perform receipt, sample handling evaluations and testing, including potential biohazardous and cytotoxic materials.

• Communicate with patients and Health Care professionals.

• Perform any other tasks as requested by Management to support Quality oversight activities