Operations Quality Pathology Customer Area Point of Contact

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The Position

As the Pathology Customer Area Single  Point of Contact (SPOC), you serve as the single point of contact for the Pathology Customer Area for the Operations Quality team.  You will be a key Operations Quality interface who works to enable the Pathology Customer Area business ambitions. You are capable of developing strategies and setting clear priorities to guide the focus of our Operations Quality networks, chapters, and squads. You will work closely with the Pathology Customer Area Lifecycle Teams (LCTs) and Functional Partners to collaborate across Networks to deliver comprehensive and successful customer solutions. You champion our Quality Management System to ensure that data-driven quality is embedded within the organization to meet customer expectations and ensure compliance with applicable global and regional regulatory requirements. You will lead one of the Operations Quality Community of Practice areas.  

As the Pathology Lab Customer Area SPOC, you will create an environment of innovation and collaboration.  You support the operational activities of the organization by promoting and developing strong connectivity with our manufacturing sites, ensuring that the organization cohesively delivers overarching product quality strategies that leverage chapters, networks, process excellence, and our continual improvement efforts. 

The Opportunity

• Deliver a capability-driven organization through tactical partnerships: Support in defining the short and long-term capability needed to deliver on the Pathology Lab Customer Area strategy, and execute on it, ultimately advancing expertise and helping our Affiliates and LCT's to achieve their business objectives. Develop strong relationships across the DIA Networks and Chapters to enhance collaboration and shared accountability using the Q&R Hubs.

• Support the delivery of mQMS: Partner with the Quality System Excellence Chapter on the strategic direction for the QMS and develop the organizational capabilities to live the mQMS as designed. Develop and lead process improvements to meet business needs taking into consideration, cost, compliance, and complexity of change. Build and maintain partnership with Network Leaderships to ensure consistency and alignment in mQMS execution across all production sites.

• Steward Knowledge Management: Champion a culture of continuous learning, fostering growth opportunities that align with Roche’s strategic goals and drive innovation and operational excellence. Establish and sustain a system that effectively creates, captures, organizes, shares, and utilizes knowledge to drive standardization and process improvement to quality-supported production activities Implement overarching strategies to transition product quality activities from solely compliance-focused to proactively quality-focused.

• Proactive Quality: Partner in the resolution of quality issues, collaborating with LCTs (Local Customer Teams or cross-functional teams, depending on the context) to prioritize and facilitate problem resolution, ultimately ensuring customer demands are met. Communicate significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner to Executive Management. Implement overarching strategies to transition product quality activities from a solely compliance-focused approach to a proactively quality-focused one.

Who You Are: 

• Bachelor’s degree in a relevant field (Engineering, Life Sciences, Quality Management, or similar). Advanced degree preferred.

• At least  five (5) years in the Medical Device/Pharma/Biopharmaceutical industry with three (3) years working in Quality, Compliance, Regulatory and/or Validation, preferred or equivalent experience. 

• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.

• Knowledge of the European, US, China and International cGMP regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.

• Proven ability to collaborate and build partnerships across cross-functional te