RAQA Automation Program Manager

Job Description:

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.

* Establish a clear vision for 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 are validated, compliant, and seamlessly integrated into the QMS and enterprise systems.

Operational Excellence & Process Redesign

* Drive end‑to‑end process simplification and standardization through Kaizens, value‑stream mapping, and digital workflow redesign.

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

* Build dashboards, analytics, and real‑time visibility tools that elevate decision‑making and improve productivity.

Change Leadership & Global Adoption

* Lead global change management efforts to ensure successful adoption of automation, new digital tools and processes across all RAQA teams.

* Develop training, communication, and capability building programs to elevate automation & digital fluency within the organization.

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

Regulatory & Compliance Stewardship

* Ensure all automation & digital solutions meet FDA, EU MDR, ISO 13485, and other applicable regulatory requirements.

* Collaborate with RAQA to ensure automation & digital enabled processes remain transparent, 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, and data-driven insights.

Job Requirements:

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 sciences preferred

* Demonstrated success leading enterprise level automation, or digital 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's automation & digital future.

* Translate complex regulatory and quality challenges into scalable automation/digital solutions.

* Build momentum and alignment across global teams.

* Deliver measurable efficiency, compliance, and capability…