Global Process Owner of Document Management

About the role

This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity.

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families. We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Responsibilities

• 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
• 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
• 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
• 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

Requirements

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

Qualifications

• 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

Travel Requirements

Up to 26 business days per year (approximately 10%).

Physical Requirements

Sedentary—Exerting up to 10 lbs (4 kg) of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.