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Director, Digital Strategy
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Overview:
Position Summary
The Director of Strategic Quality Programs is a strategic leadership role responsible for developing, overseeing, and executing enterprise-wide quality strategies, programs, and initiatives to ensure regulatory compliance, operational excellence, and continuous improvement across the organization. This role will act as a key advisor to senior leadership and partner cross-functionally to align quality objectives with business goals, driving innovation, transformation, quality culture and risk-based thinking across the company.
The Director of Strategic Quality Programs is a member of the Quality Leadership Team.
Key Responsibilities
Strategic Program Leadership
- Define, implement, and manage strategic QA programs across all GxP domains, aligned with global regulatory expectations and company objectives aiming at implementing new approaches, systems and tools for reaching the State of The Industry standards.
- Guide executive decision-making with data-driven insights, benchmarking, and business case development.
- Develop roadmaps for quality transformation aligned with global strategy.
- Serve as a key thought partner to senior leadership in shaping QA’s long-term direction.
- Establish governance, prioritization, and execution frameworks for strategic initiatives across the global QA network.
Quality Culture & Cultural Transformation
- Champion a shift from reactive compliance to proactive quality ownership across functions by appropriate use of e.g. QRM, AI, digital solutions and project management.
- Lead change management efforts to embed a culture of transparency, collaboration, operational agility, and innovation for quality in the relevant GxP areas
- Enable empowerment within QA teams and when collaborating with other functions, based on a matrix organization operating model, to drive engagement and accountability.
- Develop and maintain a targeted communication, educational and engagement programs to support the expected cultural transformation and operational excellence.
- Measure and continuously improve the maturity of the organization’s quality culture through surveys, diagnostics, and performance feedback.
Program and Project Portfolio Management
- Oversee a global portfolio of strategic quality initiatives and cross-functional transformation programs within the QA organization. Ensure appropriate alignment with other initiatives managed by internal stakeholders.
- Oversee complex, cross-functional quality programs, ensuring timely delivery, budget adherence, and measurable outcomes.
Operational Excellence
- Define and drive operational excellence frameworks within GTO and beyond, embedding Lean, Six Sigma, and continuous improvement principles into processes and organizations.
- Analyze process performance, identify inefficiencies, and implement scalable, sustainable solutions to enhance productivity and compliance.
- Establish KPIs and dashboards to monitor quality and operational performance, drive proactive risk management, and foster a data-driven decision-making culture.
- Benchmark internal quality operations against industry standards and best practices to ensure world-class performance.
AI & Data Analytics Innovation
- Partner with the quality organization, IT, and business functions to deploy AI/ML tools that enhance QA operations (e.g., predictive quality, automated trend analysis).
- Facilitate the transformation of Quality through the adoption of AI/ML solutions and digital platforms, including predictive analytics, and intelligent document processing.
- Develop frameworks for data quality governance, lifecycle management, and risk-based analytics.
- Leverage data analytics to modernize quality practices and ensure data integrity
Continuous Improvement
- Lead the development and deployment of quality risk management, process optimization, and inspection readiness initiatives.
- Strengthen global inspection readiness and regulatory alignment through proactive compliance improvement programs.
- Build capability across teams in continuous improvement and problem-solving methodologies.
- Benchmark internal quality performance against industry leaders and regulatory expectations.
Quality Risk Management
- Establish global frameworks and policies for proactive quality risk management, aligned with ICH Q9 and evolving international expectations.
- Facilitate risk identification, evaluation, and mitigation processes across the product lifecycle—from development through post-marketing surveillance.
- Support decision-making through structured risk-benefit analyses and escalation governance.
**Requirements**:
- Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering).
- Firsthand experience of min 20 years in Quality Assurance for international pharmaceutical and/or biotech industry with at least 7 years in leadership global roles.
- Lean six sigma / Operational Excellence Black Belt Certification
- Strategic thi
