Title:  Global Process Owner of Document Management

Job Summary

In this role, the Global Process Owner of Document Management is accountable for defining, owning, and continuously improving the end-to-end controlled document lifecycle for West.  This position is vital for the implementation and long-term sustainment of the Digital Quality Management (DQM) system.

This role leads a global process network interfacing with OU Quality contracts and other cross-functional stakeholders/experts to ensure consistent execution across all regions and sites. The Global Process Owner establishes enterprise standards, governance, and performance oversight, driving a One West approach to Quality. The position plays a key role in delivering a culture shift toward standardized, scalable, and efficient processes, ensuring alignment of process, systems, and reporting while eliminating unnecessary variation, duplication, and workarounds.

Global Process Owners operate as enterprise leaders and change agents, influencing across a matrix organization to drive adoption, improve performance, and ensure sustainable process execution.

This role will initially report solid line into the Quality Excellence organization to support the design, development, and deployment of global QMS processes. While on the Quality Excellence team, the role will have a dotted-line relationship with the functional manager with whom the process is operationally supported.  Upon successful implementation and stabilization of the Enterprise Document Management process(s), the role will fully transition into Corporate Quality Systems within the appropriate functional area (e.g., Quality Systems) to ensure ongoing process ownership, governance, and continuous improvement. 

Essential Duties and Responsibilities

Process Ownership:

• Own the global process end-to-end, from design through execution and continuous improvement
• Define and maintain enterprise-wide process standards, procedures, and requirements
• Ensure alignment of process, systems, and reporting across the enterprise
• Understand and represent the needs of all process users (Sites, OUs, functions)
• Make timely, enterprise-level decisions using established governance frameworks

Governance & Standardization:

• Establish and maintain global governance structures, decision rights, and escalation pathways
• Lead global process forums (e.g., monthly) with OU QMS Leads and Site SMEs
• Drive standardization of processes, terminology, workflows, and definitions
• Eliminate duplication, conflicting processes, and local/site-specific interpretations
• Control process changes, versioning, and impact across enterprise procedures and systems

Performance & Process Management:

• Define and monitor global process KPIs, ensuring performance is actively improved (not just reported)
• Identify and address performance gaps, risks, and compliance trends (cycle time, backlog, effectiveness)
• Lead root cause analysis and resolution of systemic process issues
• Maintain visibility through global dashboards and regular performance reviews
• Partner with stakeholders to ensure consistent and reliable execution across OUs and Sites
• Involvement in Corporate Quality Audits for local system and process evaluation

Continuous Improvement & Adoption:

• Lead and prioritize global process improvement initiatives aligned to QA strategy
• Drive simplification, efficiency, and scalability by reducing variation and workarounds
• Partner with Digital/Systems teams to enable enterprise solutions and automation
• Ensure effective change management, communication, and training adoption
• Maintain a continuous improvement roadmap for the process

Education

• Bachelor's Degree in a science related field or equivalent experience required
• Master's Degree in a science related field preferred

Work Experience

• 8+ years of work experience.
• 5+ years of experience in pharmaceutical or medical device environment.
• 2+ years of experience in a Quality role; ASQ CQE certification desirable.
• 5+ years of deep subject matter expertise (SME) in controlled document architecture and hierarchy, taxonomy/information architecture, workflow/approval design, change impact management, content quality/documentation rationalization, versioning/point-of-use control.

Preferred Knowledge, Skills and Abilities

• Hands on experience working in a medical device or pharmaceutical manufacturing location.
• Strong knowledge and understanding of ISO 9001, ISO 15378, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP, MDR.
• Six Sigma, PMP or similar certification preferred. 
• Work independently and in a team environment.  Experience navigating matrix/global organizations.
• Demonstrated enterprise-level deployment experience.
• Ability to convey innovativeness in a clear/structured way when proposing alternate solutions for process improvement.
• Leverage data to identify root cause and to measure improvements.
• Experience with SAP, data analytics dashboards, data governance, process automation, and Digital QMS is preferred.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.

Additional Requirements

• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures.
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of customer visits and business development related activities.
• Position operates in a professional office environment. May stand or sit for extended periods of time.
• Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
• Read and interpret data, information and documents.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Ability to make independent and sound judgments.
• Observe and interpret situations, analyze and solve problems. #LI-JJ1 #LI-HYBRID 

Travel Requirements

Physical Requirements