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

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.