Global Process Owner, Document Management & Change Control

West Pharmaceutical Services / Progressive Medical; Exton (PA); Hybrid; USD 150,000 - 185,000; Full time

Job summary

West Pharmaceutical Services is seeking a Global Process Owner for Document Management & Change Control. The role drives end-to-end lifecycle standards, governance, and continuous improvement across regions and sites, supporting a Digital Quality Management (DQM) system.

Initially reporting to the Quality Excellence organization with a dotted-line to the responsible functional manager, the position aims to transition to Corporate Quality Systems for ongoing governance and continuous improvement.

Qualifications

• Bachelor’s degree in science required; master’s preferred.
• 8+ years in related roles with pharma/medical device exposure.
• 5+ years in quality with SME for controlled documents and taxonomy.
• Experience with ISO 9001, document hierarchy, and change control.

Responsibilities

• Own end-to-end global document management processes and improvements.
• Define enterprise standards, governance, and reporting alignment.
• Lead global process forums and standardize terminology/workflows.
• Drive KPIs, identify gaps, perform root-cause analysis, and actions.
• Collaborate with SAP, Digital QMS, and system teams for automation.

Skills

Document management

Quality systems

ISO 9001 knowledge

Change management

Cross-functional collaboration

Project management

Data analytics

SAP

Education

Bachelor's Degree in a science related field

Master's Degree in a science related field

Tools

SAP

Digital QMS

Data dashboards

Job description

Description

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.

Job Summary

In this role, the Global Process Owner, Document Management & Change Control 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.

Process Ownership

Essential Duties and 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

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.

Travel Requirements

10%: Up to 26 business days per year

Physical Requirements

Sedentary-Exerting up to 10lbs/4kgs 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.

West embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.