RAQA Automation Program Manager

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* Job Description:

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* ** POSITION SUMMARY*
* This position is based on‑site and requires four days per week in the Brea office to support collaboration and business needs.

The  
** RAQA Automation Program Manager
** serves as a key enterprise leader responsible for modernizing Regulatory Affairs and Quality Assurance through advanced automation and data‑driven capabilities. This role sets the strategic direction for RAQA automation and digital operations, driving high‑impact transformation initiatives that strengthen compliance, reduce manual burden, and enable scalable, future‑ready processes across the RAQA ecosystem.

** ESSENTIAL DUTIES & RESPONSIBILITIES*
* ** Essential

Duties & Responsibilities *
* ** _Strategic Leadership & Vision_*
* + Define and own the multiyear RAQA automation strategy, aligning initiatives with enterprise priorities, regulatory expectations, and operational needs.

+ Establisha clear visionfor a digitally enabled RAQA function, including intelligent workflows, predictive analytics, and automated compliance capabilities.

+ Advise RAQA leadership on digital trends, emerging technologies, and opportunities to accelerate efficiency and compliance

** _Automation &_*
* ** _Digital_*
* ** _Program Ownership_*
* + Lead the identification, prioritization, and execution of automation and digitization of Quality Assurance,Quality Management Systems , and Regulatory Affairs.

+ Oversee the development and deployment of intelligent document processing, automated data flows, and digital inspection tools.

+ Ensure all solutions arevalidated, compliant, and seamlessly integrated into the QMS and enterprise systems.

** _Operational Excellence & Process Redesign_*
* + Driveend‑to‑end process simplification and standardization through Kaizens,value‑streammapping, and digital workflow redesign.

+ Champion automation and digital work instructions to modernize QA operations.

+ Build dashboards, analytics, andreal‑timevisibility tools that elevatedecision‑makingand improve productivity.

** _Change Leadership & Global Adoption_*
* + Lead global change management efforts to ensure successful adoption of automation,new digitaltoolsand processes across all RAQA teams.

+ Develop training, communication, and capability building programs to elevateautomation &digital fluency within the organization.

+ Partner with regional RAQA leaders to ensure consistent deployment and sustained adoption across global sites.

** _Regulatory & Compliance Stewardship_*
* + Ensure allautomation &digital solutions meet FDA, EU MDR, ISO 13485, and other applicable regulatory requirements.

+ Collaborate with RAQA to ensureautomation &digitalenabled processesremaintransparent, defensible, and compliant.

** _Cross_*
* ** _-_*
* ** _Functional_*
* ** _Influence & Collaboration_*
* + Partner with Operations, IT, R&D, and Marketing to ensure alignment and integration of automation and digital initiatives.

+ Represent RAQA on enterprise digital transformation committees, steering groups, and governance bodies.

+ Influence senior stakeholders through clear communication, strong business cases, anddata-driveninsights.

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* Job Requirements:

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* ** Qualifications*
* + Bachelor's degree in Engineering, Computer Science, Quality, Regulatory Affairs, or related field; advanced degree preferred.

+ 7+ years of experience in Operations, Quality Assurance, Regulatory Affairs, or Automation/Digital Transformation within medical devices, diagnostics, or life sciencespreferred

+ Demonstrated success leading enterprise levelautomation, ordigital transformation programs.

+ Demonstrated success implementing inspection automation, test automation, or digital QC systems.

+ Deep understanding of QMS processes, regulatory requirements, and validation of digital/automation tools.

+ Proven ability to lead global teams, influence senior stakeholders, and drive change in complex environments.

+ Exceptional communication, strategic thinking, and program management capabilities.

** A successful candidate will:*
* + Operate as a strategic architect of RAQA'sautomation &digital future.

+ Translate complex regulatory and quality challenges into scalableautomation/digital solutions.

+ Build momentum and…