QS&C Digital Enablement Lead (m/f/x)

CSL

About The Position

The QS&C Digital Enablement Lead advances digital transformation across Quality Systems & Compliance (QS&C). In partnership with stakeholders across Quality and Information & Technology (I&T), the role identifies, implements, and optimizes digital solutions that enhance compliance, efficiency, insights, and user experience. It applies technologies such as AI, automation, data analytics, Microsoft Copilot, cloud-based platforms, and other emerging capabilities to translate business needs into practical, scalable solutions in a global, highly regulated environment. The role contributes to QS&C's digital strategy and multi-year roadmap; evaluates emerging technologies and their business value, compliance, scalability, and operational impact; and translates business and compliance requirements into use cases, requirements, and implementation plans. It collaborates with I&T, vendors, technical teams, and process owners to deliver solutions, support change management and adoption, and realize benefits while ensuring alignment with GMP requirements, regulatory expectations, and internal governance. The position serves as business lead for assigned digital quality initiatives, platforms, and services; improves tools, knowledge repositories, workflows, and collaboration solutions, including SharePoint-based platforms where applicable; and supports KPI reporting, analytics, performance monitoring, training, knowledge sharing, audit and inspection readiness, and continuous improvement. It also advises on digital technologies in regulated environments, including governance, compliance, risk management, and data integrity, and builds partnerships across Quality, I&T, vendors, and business stakeholders. CSL Behring is a global biotherapeutics leader. Its parent company, CSL, is headquartered in Melbourne, Australia, employs 32,000 people, and delivers therapies in more than 100 countries. The role requires working effectively in a global, matrixed environment and willingness to travel internationally up to 10% of the time.

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Engineering, Information Technology, Quality, or a related field.
Significant experience in the pharmaceutical, biotechnology, medical device, or another highly regulated industry.
Strong knowledge of Quality Management Systems (QMS) and regulated processes, including deviations, CAPA, controlled documentation, training, audits, inspections, and regulatory requirements.
Experience evaluating, implementing, or enabling digital technologies such as AI, automation, cloud solutions, data analytics, intelligent workflows, or other emerging technologies.
Ability to translate business and compliance requirements into practical, scalable digital solutions.
Experience working across Quality, I&T, technical teams, vendors, and senior stakeholders in complex, matrixed organizations.
Experience supporting audit and inspection readiness activities.
Strong understanding of GxP requirements, quality-system governance, and regulatory expectations.
Knowledge of digital technologies and their application in regulated environments.
Experience with collaboration, knowledge-management, analytics, and workflow platforms.
Understanding of data integrity, digital governance, and risk management principles.
Strategic mindset and ability to translate vision into action, with strong execution skills and a hands-on approach.
Strong stakeholder management, relationship-building, communication, and influencing skills across organizational levels.
Ability to work independently, manage multiple priorities, solve problems, and make decisions in a dynamic environment.
Learning agility, curiosity about emerging technologies and industry trends, and an innovative, continuous-improvement mindset focused on business value.
Ability to influence and drive outcomes without direct authority and to operate across cultures, functions, and levels in a global organization.
Ability to work effectively in a global, matrixed environment.
Willingness to travel internationally up to 10% of the time.

Nice To Haves

Advanced degree or relevant professional certifications.
Project, product, digital transformation, or change management experience is highly desirable.

Responsibilities

Contribute to the development and execution of the QS&C digital strategy and multi-year roadmap.
Partner with Quality, Digital Quality, and I&T stakeholders to identify, prioritize, and deliver digital initiatives.
Define objectives, business value, success measures, risks, and implementation approaches for digital programs.
Identify opportunities to improve quality processes, user experience, and operational effectiveness through digital innovation.
Monitor developments in AI, automation, data analytics, cloud technologies, augmented reality, and other emerging capabilities.
Evaluate technologies for business value, compliance, scalability, and operational impact; bring external best practices and trends into the organization.
Translate business and compliance requirements into use cases, business requirements, and implementation plans.
Collaborate with I&T, vendors, technical teams, and process owners to design, implement, and optimize digital solutions.
Support change management, user adoption, training, and benefit realization for digital implementations.
Ensure solutions align with GMP requirements, regulatory expectations, and internal governance standards.
Serve as business lead for assigned digital quality initiatives, platforms, and services.
Manage and improve digital tools, knowledge repositories, workflows, and collaboration solutions, including SharePoint-based platforms where applicable.
Support KPI reporting, data analytics, and performance monitoring across Quality; identify trends, risks, and improvement opportunities.
Support digital solutions for training effectiveness and knowledge sharing, and promote consistent approaches to managing quality and process knowledge.
Provide digital quality expertise for internal audits, regulatory inspections, and inspection readiness; maintain appropriate compliance, documentation, and control.
Advise on digital technologies in regulated environments, including governance, compliance, risk management, and data integrity.
Build stakeholder relationships and facilitate alignment across Quality, I&T, technical teams, vendors, and business stakeholders.
Promote experimentation, adoption of valuable emerging technologies, and continuous improvement across QS&C.
Participate in professional networks, conferences, and industry forums to bring external practices and trends into the organization.
Work effectively in a global, matrixed environment and travel internationally up to 10% of the time.