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Director, MSAT Validation & Digital - Job Opportunity at Johnson & Johnson

Cork, Ireland
Full-time
Executive
Posted: July 3, 2025
On-site
EUR 120,000 - 160,000 per year, reflecting the executive-level responsibility, specialized expertise in both validation and digital transformation, and Johnson & Johnson's position as a premium employer in the pharmaceutical sector

Benefits

Opportunity to work on breakthrough healthcare innovations that save lives and impact global health outcomes
Access to cutting-edge digital transformation and automation technologies in a regulated pharmaceutical environment
Leadership role in a Fortune 500 company with extensive global reach and market influence
Professional development through mentoring validation and compliance teams in advanced therapeutic areas
Exposure to regulatory compliance frameworks including GMP, GDP, and ISO standards
Cross-functional collaboration with Quality Assurance, Regulatory Affairs, and IT departments
Equal opportunity employment with comprehensive diversity and inclusion initiatives
Accommodation support for employees with disabilities through dedicated health support services

Key Responsibilities

Drive strategic validation framework development that ensures regulatory compliance across Advanced Therapies Supply Chain, directly impacting product quality and patient safety
Lead digital transformation initiatives by implementing automated processing tools that revolutionize validation workflows and operational efficiency
Establish comprehensive data management protocols that ensure data integrity and support critical compliance objectives across multiple therapeutic areas
Develop organizational capabilities through strategic training and mentorship of validation professionals, building a culture of continuous improvement
Execute stakeholder collaboration across Quality Assurance, Regulatory Affairs, and IT to align validation activities with enterprise business goals
Maintain regulatory compliance leadership by staying current with industry standards and leading inspections and audits
Implement advanced analytics and data visualization techniques to monitor validation processes and compliance metrics
Spearhead process automation opportunities that enhance validation and compliance functions across the organization

Requirements

Education

Bachelor's degree in Science, Engineering, Computer Science, or a related field; Master's degree preferred

Experience

10-12 years of experience

Required Skills

Proven experience in validation processes, automation, and digital transformation, preferably within a regulated industry Strong understanding of compliance requirements and regulatory frameworks Proficiency in data analytics tools and automated validation software Excellent project management skills, with the ability to lead and prioritize multiple initiatives Strong analytical and problem-solving skills with attention to detail Exceptional communication and interpersonal skills Familiarity with industry standards such as GMP, GDP, and ISO Experience with programming languages and database management Knowledge of machine learning and advanced data processing techniques
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Sauge AI Market Intelligence

Industry Trends

The pharmaceutical industry is experiencing unprecedented digital transformation with companies investing heavily in automation and AI-driven validation processes to reduce time-to-market and improve compliance efficiency. This trend is particularly accelerated by regulatory bodies embracing digital submissions and electronic validation documentation. Advanced therapies including cell and gene therapies are driving demand for specialized validation expertise, as these complex treatments require novel validation approaches and digital solutions to manage their unique manufacturing and supply chain challenges. Regulatory compliance is becoming increasingly complex with evolving global standards, creating high demand for professionals who can navigate multiple regulatory frameworks while implementing digital solutions that ensure consistent compliance across international markets. The integration of machine learning and advanced analytics into pharmaceutical validation processes is becoming standard practice, with companies seeking leaders who can bridge the gap between traditional validation methods and cutting-edge digital technologies.

Role Significance

Typically manages 15-25 professionals across validation, compliance, and digital implementation functions, with indirect influence over broader cross-functional teams including Quality Assurance, Regulatory Affairs, and IT departments
This is a senior executive position with significant strategic influence over compliance and operational efficiency across Johnson & Johnson's Advanced Therapies Supply Chain. The role carries responsibility for driving digital transformation initiatives that directly impact product quality, regulatory compliance, and business outcomes.

Key Projects

Implementation of automated validation systems for advanced therapy manufacturing processes Development of digital compliance frameworks that integrate with existing quality management systems Leading regulatory inspection readiness initiatives across multiple therapeutic areas Establishing data integrity protocols for complex biological and advanced therapy products Cross-functional digital transformation projects that enhance supply chain visibility and compliance monitoring

Success Factors

Deep understanding of both traditional pharmaceutical validation principles and emerging digital technologies, enabling effective bridge-building between established compliance practices and innovative automation solutions Strong leadership and change management capabilities to drive digital transformation initiatives across established pharmaceutical manufacturing operations where resistance to change may be significant Exceptional regulatory knowledge spanning multiple global markets, particularly in advanced therapies where regulatory landscapes are rapidly evolving and require adaptive compliance strategies Data analytics expertise combined with pharmaceutical domain knowledge to develop meaningful insights from complex validation and compliance datasets Strategic thinking ability to align validation and digital initiatives with broader business objectives while maintaining uncompromising focus on patient safety and product quality

Market Demand

Very High - The combination of validation expertise and digital transformation leadership in pharmaceutical manufacturing represents a critical skill gap in the industry, with limited qualified candidates available globally

Important Skills

Critical Skills

Validation process expertise is fundamental as pharmaceutical manufacturing operates under strict regulatory oversight, and any validation failures can result in product recalls, regulatory sanctions, and significant financial impact. This knowledge forms the foundation for all digital transformation initiatives in this role. Digital transformation and automation capabilities are essential because the pharmaceutical industry is rapidly adopting digital solutions to improve efficiency and compliance. Leaders who cannot drive these initiatives effectively will find their organizations falling behind competitors in operational excellence. Regulatory compliance understanding across multiple frameworks (GMP, GDP, ISO) is critical because pharmaceutical products must meet stringent regulatory requirements in multiple global markets. Non-compliance can result in facility shutdowns and product withdrawals. Data analytics and visualization skills are increasingly important as pharmaceutical companies generate vast amounts of validation and compliance data that must be analyzed to identify trends, predict issues, and demonstrate regulatory compliance through data-driven insights.

Beneficial Skills

Programming and database management skills provide significant advantage in implementing custom validation solutions and integrating disparate systems, enabling more sophisticated automation and data management capabilities Machine learning knowledge offers competitive advantage in developing predictive models for validation processes, anomaly detection in manufacturing data, and optimization of compliance workflows Project management certification would enhance ability to manage complex digital transformation initiatives involving multiple stakeholders and competing priorities International regulatory experience beyond EU and US markets would be valuable as Johnson & Johnson continues expanding into emerging markets with unique regulatory requirements

Unique Aspects

This role uniquely combines traditional pharmaceutical validation expertise with cutting-edge digital transformation leadership, representing the evolution of compliance functions in modern pharmaceutical manufacturing
The position offers dual-location flexibility between Raritan, NJ and Cork, Ireland, providing international exposure and the opportunity to influence global validation strategies
Focus on Advanced Therapies Supply Chain represents work at the forefront of pharmaceutical innovation, including cell and gene therapies that are revolutionizing treatment approaches
The role involves direct collaboration with multiple high-level functions including Quality Assurance, Regulatory Affairs, and IT, providing broad organizational influence and visibility
Integration of machine learning and advanced analytics into validation processes represents a pioneering approach that few pharmaceutical companies have successfully implemented at scale

Career Growth

3-5 years for progression to VP level, given the strategic nature of this role and the high-growth digital transformation focus within Johnson & Johnson

Potential Next Roles

Vice President of Manufacturing Science and Technology with broader operational responsibility Head of Global Compliance and Validation across multiple therapeutic areas Chief Digital Officer for pharmaceutical manufacturing operations Site General Manager for major pharmaceutical manufacturing facilities Consulting leadership roles helping other pharmaceutical companies with digital transformation

Company Overview

Johnson & Johnson

Johnson & Johnson is the world's largest healthcare company with over $90 billion in annual revenue, operating across three main sectors: pharmaceuticals, medical devices, and consumer products. The company has established itself as a leader in innovative medicines and advanced therapies, with particular strength in oncology, immunology, and neuroscience.

Johnson & Johnson maintains the #1 position globally in healthcare with strong market presence across all therapeutic areas. The company's pharmaceutical division alone generates over $50 billion annually, making it one of the most influential players in global drug development and manufacturing.
The Cork, Ireland location represents Johnson & Johnson's significant European manufacturing and development hub, serving as a strategic base for advanced therapy production and regulatory compliance across EU markets. This facility plays a crucial role in the company's global supply chain strategy.
Johnson & Johnson is known for its strong emphasis on innovation, patient-centered focus, and collaborative work environment. The company culture emphasizes continuous learning, diversity and inclusion, and long-term career development, with particular support for employees driving digital transformation initiatives.
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