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

CSL; Bern; On-site; CHF 180,000 - 240,000; Full time

Job summary

CSL is seeking a QS&C Digital Enablement Lead to advance digital transformation across Quality Systems & Compliance. You will partner with Quality and IT to identify, implement, and optimize digital solutions that improve compliance, efficiency, insights, and user experience.

The role blends strategy with hands-on delivery in a global regulated environment. You will leverage AI, automation, data analytics, cloud platforms, and Microsoft Copilot to translate business needs into scalable digital

Qualifications

• Significant experience in regulated industries (pharma/biotech/medical devices).
• Strong knowledge of QMS and regulated processes (deviations, CAPA, controlled docs, audits/inspections).
• Experience evaluating or enabling digital technologies (AI, automation, cloud, data analytics).
• Ability translating business and compliance requirements into practical digital solutions.
• Experience collaborating across Quality, IT, vendors, and senior stakeholders in complex organizations.
• Experience supporting audit and inspection readiness.

Responsibilities

• Drive Digital Strategy and Transformation across QS&C and I&T.
• Identify and deliver high-value digital initiatives with stakeholders.
• Define objectives, value, and success metrics for digital programs.
• Translate requirements into use cases and implementation plans.
• Support change management, training, and benefit realization.

Skills

Strategic thinking

Stakeholder management

Change management

Data analytics

Cloud technologies

AI & automation

Education

Bachelor's degree (Life Sciences / Pharmacy / Engineering / IT)

Advanced degree or certifications preferred

Tools

SharePoint

Job description

The QS&C Digital Enablement Lead plays a key role in advancing digital transformation across Quality Systems & Compliance (QS&C). Partnering with stakeholders across Quality and Information & Technology (I&T), you will identify, implement, and optimize digital solutions that enhance compliance, efficiency, insights, and user experience.

Leveraging technologies such as AI, automation, data analytics, Microsoft Copilot, cloud-based platforms, and other emerging digital capabilities, you will help translate business needs into practical, scalable solutions. This role combines strategic thinking with hands‑on execution and offers the opportunity to shape the future of digital quality in a global, highly regulated environment.

Responsibilities & Accountabilities

Drive Digital Strategy and Transformation

• Contribute to the development and execution of the QS&C digital strategy and multi‑year roadmap.
• Partner with stakeholders across Quality, Digital Quality, and I&T to identify, prioritize, and deliver high‑value digital initiatives.
• Define objectives, business value, success measures, risks, and implementation approaches for digital programs.
• Continuously identify opportunities to improve quality processes, user experience, and operational effectiveness through digital innovation.

Identify and Leverage Emerging Technologies

• Monitor developments in AI, automation, data analytics, cloud technologies, augmented reality, and other emerging digital capabilities.
• Evaluate new technologies for business value, compliance, scalability, and operational impact.
• Bring external best practices and industry trends into the organization through active participation in professional networks, conferences, and industry forums.

Deliver Digital Quality Solutions

• Translate business and compliance requirements into actionable 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 to ensure successful implementation and sustainable outcomes.
• Ensure all solutions align with GMP requirements, regulatory expectations, and internal governance standards.

Own and Enhance Digital Platforms and Services

• Serve as the business lead for assigned digital quality initiatives, platforms, and services.
• Manage and continuously improve digital tools, knowledge repositories, workflows, and collaboration solutions, including SharePoint‑based platforms where applicable.
• Ensure solutions remain compliant, effective, scalable, and aligned with evolving business needs.

Enable Quality Performance and Insights

• Support KPI reporting, data analytics, and performance monitoring across the Quality organization.
• Identify trends, risks, and improvement opportunities through data‑driven insights.
• Help establish digital capabilities that support informed decision‑making and continuous improvement.

Strengthen Knowledge Management and Training

• Support the development and maintenance of digital solutions that enhance training effectiveness and knowledge sharing.
• Promote consistent approaches for capturing, managing, and disseminating critical quality and process knowledge.
• Foster adoption of digital tools and best practices across the organization.

Support Audit and Inspection Readiness

• Provide digital quality expertise to support internal audits, regulatory inspections, and inspection readiness activities.
• Ensure digital solutions and processes maintain appropriate levels of compliance, documentation, and control.
• Apply risk‑based thinking when evaluating and implementing technology‑enabled quality processes.

Act as a Trusted Digital and Quality Advisor

• Provide guidance on digital technologies within regulated environments, including governance, compliance, risk management, and data integrity considerations.
• Communicate complex technical and quality concepts effectively to a wide range of audiences.
• Champion responsible innovation, continuous improvement, and effective use of digital technologies across QS&C.

Build Strong Stakeholder Partnerships

• Develop trusted relationships across Quality, I&T, technical teams, vendors, and business stakeholders.
• Facilitate alignment among diverse stakeholder groups to enable successful delivery of digital initiatives.
• Influence decisions and outcomes through collaboration, credibility, and expertise.

Promote Innovation and Continuous Improvement

• Challenge existing approaches and identify opportunities for smarter, more efficient ways of working.
• Encourage experimentation and adoption of emerging technologies where they deliver measurable value.
• Help shape the future digital landscape of Quality through continuous learning, innovation, and external engagement.

Qualifications & Requirements

Education

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Information Technology, Quality, or a related field.
• Advanced degree or relevant professional certifications preferred.

Experience

• Significant experience within the pharmaceutical, biotechnology, medical device, or other highly regulated industries.
• 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.
• Demonstrated ability to translate business and compliance requirements into practical, scalable digital solutions.
• Experience working effectively across Quality, I&T, technical teams, vendors, and senior stakeholders within complex, matrixed organizations.
• Experience supporting audit and inspection readiness activities.
• Project, product, digital transformation, or change management experience is highly desirable.

Knowledge & Technical Skills

• Strong understanding of GxP requirements, quality-system governance, and regulatory expectations.
• Knowledge of digital technologies and their application within regulated environments.
• Experience with collaboration, knowledge‑management, analytics, and workflow platforms.
• Understanding of data integrity, digital governance, and risk management principles.

Competencies

• Strategic mindset with the ability to translate vision into action.
• Strong execution skills and a hands‑on approach to delivery.
• Excellent stakeholder management and relationship‑building capabilities.
• Strong communication and influencing skills across all organizational levels.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• Analytical thinker with strong problem‑solving and decision‑making skills.
• Learning agility and curiosity for emerging technologies and industry trends.
• Innovative mindset with a focus on continuous improvement and business value.
• Ability to influence and drive outcomes without direct authority.
• Comfortable operating across cultures, functions, and levels within a global organization.

Additional Requirements

• Ability to work effectively in a global, matrixed environment.
• Willingness to travel internationally up to 10% of the time.