We are looking for our next Director of Quality Control (QC) who will be an integral member of the Tissue Diagnostics Global Operations leadership team. In this matrixed organization, you will lead, inspire and empower a skilled team of scientists and quality professionals that are responsible for the safe & efficient testing of Tissue Diagnostic Assays and Reagents. 

You will be responsible for the development and implementation of Quality Control processes and testing standards across the manufacturing operation to ensure compliance and ensure the right to operate. 

You will also be responsible for addressing non-conforming events through technical experts and develop and implement long term sustainable corrective actions. You’ll work closely with the Oncology and Personalized Healthcare Solutions team to support development of new products and the Pathology office for implementation of appropriate test methods and product release specifications. You’ll work cross functionally to support troubleshooting of customer complaints and product quality related issues in a timely fashion. 

You’ll support our VP, Manufacturing Operations to execute long-term manufacturing strategy while managing short-term objectives while demonstrating and advocating our Roche Operating Principles, Roche Values and Roche Leadership Commitments.

 Additional responsibilities include:

• Leading the incoming inspection team, finished product testing team and daily technical support teams that are assigned to the Quality Control (QC) department.  Providing guidance to QC team on establishing and achieving goals that meet the needs of the customer and the business.

• Lead with a “servant leadership” mentality; apply Roche Leadership Principles (Visionary, Architect, Coaching and Catalyst) as a standard way of leading direct staff towards achieving targets.

• Preparing the site for audit readiness (OSHA, FDA, Area audits, etc.); represent manufacturing operations during internal audits & inspections.

• Lead the implementation of the applicable quality compliance standards and appropriate modules for the Roche modular Quality Management System (mQMS).

• Manage P&L achievements, budget creation and execution, CapEx management, provides strategic decision-making, and plans for the efficient and effective use of resources within the Quality Control department.

• Act as a change agent and drive a culture of continuous improvement by actively demonstrating the use of Lean Manufacturing tools in everything the team does to improve efficiencies within the organization and achieving customer satisfaction.

• Lead the development of production quality standards, methods, policies across manufacturing operations collaborating with the development and quality assurance teams.

• Provide technical leadership to address non-conforming events – Laboratory Exception Events, Out of Specifications, Non-Conformances & Corrective and Preventive Actions – and audit findings by conducting effective root cause investigations and implementing corrective actions in a timely and compliant manner. 

• Lead implementation of procedural controls and monitors effectiveness using data analytics.

• Drive the development and implementation of improved Quality Control processes through industry best practices such as Statistical Process Control.

• Develop, maintain and report internal KPI’s to demonstrate performance of the QC function.

•  Support direct Procurement team for critical supplier quality performance evaluations, managing standardized specifications and material acceptance criteria. 

• Support value engineering projects for improving cost and quality.

• Support Operations and Development design transfer teams for development and validation of robust test methods and product release specifications for product release to the customers.

• Support process engineering team to optimize processes and validation of production and process control parameters.

• Prepare and manage budgets and resource needs, assigns projects to appropriate team members and ensures progress of the projects through completion.

Requirements:

• Bachelor’s degree in life sciences or other engineering related discipline.

• Master's degree or higher in Life Sciences/Engineering discipline is an asset but not required.

• 10 years of progressive leadership experience in diagnostics/medical device or pharmaceutical industry, quality control, non- conformance management, process control, product transfers, requirements development and creating & implementing quality compliance processes.

• Experience in a data driven decision making regulated environment

• Demonstrated experience developing quality compliance processes, utilizing Lean Sigma tools, data analytics and process controls in a best-in-class manufacturing environment.

•  Proven track record of driving and leading change.

Knowledge, Skills and Abilities:

• Strong organizational and problem-solving skills including the ability to develop and follow written procedures, document work accurately and guide others in the same.

• Key attributes: Strong leadership, technical expertise preferably in Assays, data analytics, decision making, quality mindset, team player, strategic thinker.

• Experience in Immunohistochemistry analytical methods is preferable.

• Leadership skills to manage technical personnel - technicians, scientists.

• Knowledge of department finance and project P&L.

Relocation benefits are available for this job posting.

For questions about this opportunity, please contact Carla Baja, Principal Talent Partner, at alegadoc@gene.com who is managing this search.