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Program Manager (Electronic Batch Records) - Job Opportunity at GerTEK Project Management and Technical Services

County Mayo, Ireland
Full-time
Senior
Posted: August 6, 2025
On-site
EUR 75,000 - 95,000 annually based on senior-level program management role in Ireland's expanding life sciences sector, with potential for performance bonuses given the critical nature of the digital transformation initiative

Benefits

Opportunity to lead a high-impact digital transformation initiative that directly shapes the organization's technological future
High degree of professional autonomy enabling independent decision-making and strategic leadership
Cross-functional team leadership experience providing valuable management and mentorship skills
Direct exposure to senior leadership including the Director of Digital Transformation for enhanced visibility and career advancement
Hands-on experience with cutting-edge digital manufacturing technologies positioning for future industry opportunities

Key Responsibilities

Drive comprehensive end-to-end implementation of enterprise-level eBR/RBE systems representing a critical organizational digital transformation milestone
Develop and execute master project planning strategies ensuring accountability and milestone achievement across multi-year complex initiatives
Lead organizational change management efforts including stakeholder consensus building and business process redesign to support digital adoption
Oversee complete system validation processes ensuring regulatory compliance and quality standards adherence in life sciences manufacturing
Manage program financials including budget oversight and ROI modeling to demonstrate business value and investment returns
Provide executive-level communication and status reporting to site leadership and digital transformation directors
Guide and mentor diverse cross-functional teams including internal resources and external contractors in complex matrix organizational structures

Requirements

Education

A Bachelor's Degree or higher in a relevant field (Engineering, Science, or Technology is a distinct advantage)

Experience

6+ years of experience in a manufacturing, supply chain, engineering, or process development environment

Required Skills

Proven experience in successfully planning and executing large-scale, complex projects Strong leadership skills with demonstrated experience leading cross-functional teams Excellent communication and influencing skills, with the ability to engage with peers and senior management effectively Program management experience in supporting NPI within a sterile manufacturing environment

Certifications

A formal qualification in Project Management (e.g., PMP) is a plus, but not essential
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Sauge AI Market Intelligence

Industry Trends

The life sciences manufacturing sector is experiencing unprecedented digital transformation acceleration, with Electronic Batch Records becoming the industry standard as companies move away from paper-based systems to improve compliance, reduce errors, and enhance operational efficiency. This shift is driven by regulatory pressures, cost reduction initiatives, and the need for real-time data visibility in pharmaceutical and biotechnology manufacturing. Manufacturing digitalization is increasingly focused on integrated systems that combine batch recording with advanced analytics and AI-driven insights, making professionals with experience in both traditional manufacturing processes and digital system implementation highly valuable in the current market. The Irish life sciences sector has seen significant growth with major pharmaceutical companies establishing European operations, creating sustained demand for senior program managers who can bridge technical manufacturing expertise with digital transformation capabilities.

Role Significance

Typically managing cross-functional teams of 8-15 professionals including internal stakeholders from manufacturing, quality, IT, and external contractors, requiring matrix management skills and influence without direct authority
Senior-level position with significant organizational impact, evidenced by direct reporting to digital transformation leadership, autonomous decision-making authority, and responsibility for site-wide system implementation affecting core manufacturing operations

Key Projects

Enterprise-wide manufacturing system implementations spanning 18-24 months with multi-million euro budgets Regulatory compliance validation projects requiring coordination with quality assurance and regulatory affairs teams Change management initiatives involving process redesign and stakeholder training across manufacturing operations

Success Factors

Demonstrated ability to navigate complex regulatory environments while driving technological innovation, balancing compliance requirements with operational efficiency improvements Strong stakeholder management capabilities to build consensus among diverse groups including manufacturing operations, quality assurance, IT departments, and senior leadership with potentially competing priorities Technical depth in manufacturing processes combined with digital systems knowledge to effectively bridge traditional operations with modern technology solutions Financial acumen to develop compelling business cases and ROI models that secure continued investment and demonstrate value delivery throughout the implementation lifecycle

Market Demand

High demand driven by widespread digitalization initiatives across pharmaceutical and biotechnology manufacturing, with limited supply of professionals combining manufacturing experience with digital transformation leadership capabilities

Important Skills

Critical Skills

Program management expertise is essential for coordinating complex, multi-phase implementations involving diverse stakeholder groups, tight regulatory requirements, and significant financial investments where delays can impact manufacturing operations and regulatory compliance Manufacturing process knowledge provides the foundation for understanding how digital systems must integrate with existing operations while maintaining product quality and regulatory compliance in highly regulated pharmaceutical environments Change management capabilities are crucial for driving organizational adoption of new systems and processes, particularly in manufacturing environments where resistance to change can impact both compliance and operational efficiency

Beneficial Skills

Advanced project management certifications like PMP provide credibility and structured methodologies for managing complex initiatives, though practical experience and industry knowledge often carry equal weight in life sciences organizations Financial modeling and business case development skills become increasingly important as organizations require clear ROI justification for major technology investments in competitive pharmaceutical markets Regulatory affairs knowledge enhances ability to navigate FDA and EMA requirements for electronic records systems, providing additional value in highly regulated manufacturing environments

Unique Aspects

Opportunity to lead a complete digital transformation of manufacturing records systems, providing comprehensive experience across all phases of enterprise system implementation from conception to deployment
Direct involvement in shaping organizational digital strategy at the site level, offering strategic influence beyond typical program management roles
Matrix leadership environment requiring advanced influence and negotiation skills to drive results through cross-functional collaboration without direct reporting relationships
Integration of Review by Exception (RBE) systems with Electronic Batch Records represents advanced manufacturing technology implementation beyond standard digitalization projects

Career Growth

Typical progression to director-level roles within 3-4 years given successful delivery of major digital transformation initiatives and demonstrated leadership capabilities

Potential Next Roles

Director of Digital Transformation positions overseeing multiple sites and broader technology initiatives within pharmaceutical organizations Head of Manufacturing Operations roles combining traditional manufacturing leadership with digital innovation responsibilities Senior Consulting positions with major life sciences consulting firms specializing in digital transformation and regulatory compliance

Company Overview

GerTEK Project Management and Technical Services

GerTEK operates as a specialized engineering consultancy focused exclusively on life sciences and technology sectors, providing project management, talent solutions, and commissioning qualification and validation services to pharmaceutical and biotechnology companies requiring specialized regulatory and technical expertise.

Mid-tier consultancy with strong regional presence in Ireland's life sciences corridor, competing with larger international firms by offering specialized expertise and personalized service delivery in the highly regulated pharmaceutical manufacturing environment
Strategic positioning in County Mayo aligns with Ireland's growing pharmaceutical manufacturing hub, providing access to major multinational pharmaceutical operations while offering competitive cost structure compared to Dublin-based alternatives
Professional services environment emphasizing client delivery excellence, technical expertise development, and project-based work structure that provides exposure to diverse manufacturing environments and cutting-edge technological implementations
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