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Technical Program Manager (Pharma) - Job Opportunity at GerTEK Project Management and Technical Services

County Mayo, IE
Full-time
Senior
Posted: August 6, 2025
On-site
EUR 85,000 - 115,000 annually. This estimate reflects the senior-level nature of the role, specialized pharmaceutical industry experience requirements, and Ireland's competitive market for digital transformation leaders in life sciences. The salary range accounts for the complex regulatory environment, cross-functional leadership responsibilities, and the critical nature of the digital transformation initiative.

Key Responsibilities

Lead comprehensive end-to-end implementation of enterprise-level Electronic Batch Record (eBR) and Review by Exception (RBE) systems, directly impacting manufacturing efficiency and regulatory compliance across the entire site
Develop and execute strategic master project plans with accountability frameworks that ensure delivery of critical digital transformation milestones over a two-year implementation cycle
Drive organizational change management initiatives by gathering complex business requirements, redesigning manufacturing processes, and building stakeholder consensus to support digital adoption
Oversee comprehensive system validation processes ensuring full regulatory compliance with pharmaceutical Quality and IT policies, directly supporting product safety and market authorization
Manage program financials including budget tracking and ROI modeling to demonstrate measurable business value and justify continued investment in digital transformation
Provide executive-level communication and reporting to site leadership and Director of Digital Transformation, ensuring strategic alignment and visibility of program progress
Lead and mentor cross-functional teams including internal resources and external contractors in complex matrix organizational structures, ensuring optimal resource utilization and team performance

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

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 pharmaceutical industry is experiencing rapid digital transformation driven by regulatory pressures for data integrity, manufacturing efficiency demands, and the need for real-time visibility into production processes. Electronic Batch Records represent a critical component of Pharma 4.0 initiatives, enabling companies to reduce manufacturing cycle times, improve compliance documentation, and enhance product quality through automated exception handling. Regulatory agencies including FDA and EMA are increasingly emphasizing data integrity requirements, making robust electronic systems essential for maintaining compliance and avoiding costly regulatory actions. The implementation of systems like eBR and RBE directly addresses 21 CFR Part 11 compliance requirements and supports serialization mandates. The COVID-19 pandemic has accelerated digital adoption in pharmaceutical manufacturing, with companies recognizing the need for remote monitoring capabilities, paperless operations, and automated quality systems to maintain operations during disruptions while ensuring product quality and regulatory compliance.

Role Significance

Likely managing a cross-functional team of 15-25 professionals including IT specialists, quality assurance personnel, manufacturing engineers, validation specialists, and external contractors, requiring sophisticated matrix management skills across multiple departments and external partnerships.
Senior-level position with significant strategic impact, evidenced by direct reporting relationships to site leadership and Director of Digital Transformation, autonomous decision-making authority, and responsibility for a multi-year, site-wide transformation initiative that will fundamentally change manufacturing operations.

Key Projects

Enterprise-wide Manufacturing Execution System (MES) implementations involving integration with existing ERP and quality management systems Regulatory compliance initiatives including CSV (Computer System Validation) activities and Part 11 compliance projects Digital transformation programs encompassing process digitization, workflow automation, and data integrity enhancement initiatives

Success Factors

Deep understanding of pharmaceutical manufacturing processes and regulatory requirements, particularly around batch record management, quality systems, and validation protocols, enabling effective translation between technical and business stakeholders while ensuring compliance throughout the transformation Exceptional stakeholder management and change leadership capabilities, essential for driving adoption of new digital processes across traditionally conservative pharmaceutical manufacturing environments where resistance to change can significantly impact project success Strong financial acumen and ROI modeling skills to demonstrate business value, secure continued funding, and justify investment decisions to senior leadership while managing complex budget allocations across multiple workstreams and vendor relationships Technical project management expertise combined with pharmaceutical industry knowledge, enabling effective coordination of complex system integrations while maintaining focus on manufacturing efficiency, product quality, and regulatory compliance objectives

Market Demand

High demand driven by industry-wide digital transformation initiatives, regulatory compliance requirements, and the specialized skill set combining pharmaceutical manufacturing knowledge with digital program management expertise.

Important Skills

Critical Skills

Pharmaceutical manufacturing process knowledge is absolutely essential as it provides the foundation for understanding how electronic batch records integrate with existing manufacturing operations, quality control processes, and regulatory reporting requirements. Without this industry-specific knowledge, program managers cannot effectively translate business requirements, anticipate implementation challenges, or ensure compliance with pharmaceutical manufacturing standards. Cross-functional team leadership capabilities are crucial given the matrix organizational structure and the need to coordinate across multiple departments including IT, Quality Assurance, Manufacturing, and external contractors. The success of digital transformation initiatives depends heavily on the ability to align diverse stakeholders with varying priorities and technical backgrounds toward common objectives. Change management expertise is critical in pharmaceutical environments where regulatory compliance concerns and established processes create natural resistance to new systems. The ability to build consensus, address concerns, and drive adoption of new digital processes directly impacts the success of the transformation initiative and long-term business value realization.

Beneficial Skills

Advanced data analytics and process optimization skills would enhance the ability to identify opportunities for manufacturing efficiency improvements and develop compelling business cases for additional digital investments based on eBR/RBE system data Regulatory affairs knowledge beyond basic compliance requirements, including understanding of international regulatory frameworks and emerging guidelines for digital systems, would provide strategic advantage in designing future-ready systems and supporting global expansion initiatives Supply chain and logistics expertise would enable broader integration opportunities and support development of end-to-end digital manufacturing ecosystems that extend beyond batch record management to encompass procurement, inventory management, and distribution optimization

Unique Aspects

This role offers rare exposure to cutting-edge pharmaceutical digital transformation at the intersection of manufacturing operations and regulatory compliance, providing invaluable experience in emerging technologies that will define the future of pharmaceutical manufacturing
The two-year program timeline and site-wide scope provide exceptional opportunity to lead a complete digital transformation lifecycle, from strategy development through implementation and optimization, offering comprehensive experience rarely available in single projects
The combination of technical program management with pharmaceutical manufacturing expertise creates a highly specialized skill set that is increasingly valuable as the industry undergoes digital transformation while maintaining stringent regulatory requirements
Direct reporting to Director of Digital Transformation and site leadership provides strategic visibility and influence, offering accelerated career development opportunities and exposure to executive-level decision making in digital strategy

Career Growth

Typical progression to director-level roles occurs within 3-5 years, particularly following successful completion of major transformation initiatives like this eBR/RBE implementation, with progression timeline dependent on demonstrated ROI, stakeholder feedback, and expanded scope of responsibilities

Potential Next Roles

Director of Digital Transformation or Chief Digital Officer roles within pharmaceutical or biotechnology companies, leading enterprise-wide digital strategy and multiple concurrent transformation initiatives Senior Program Management roles at larger pharmaceutical companies managing portfolios of digital initiatives across multiple sites or therapeutic areas Consulting leadership positions at specialized life sciences consulting firms, providing strategic guidance to pharmaceutical companies on digital transformation and regulatory compliance initiatives

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 (CQV) services. The company positions itself at the intersection of technical expertise and regulatory compliance, serving pharmaceutical and biotechnology clients who require specialized knowledge of both engineering principles and regulatory requirements.

Established niche player in the Irish and European life sciences consulting market, competing with larger international consulting firms by offering specialized pharmaceutical manufacturing expertise and regulatory knowledge, particularly in areas requiring deep technical understanding of validation, qualification, and compliance processes.
County Mayo location suggests either a client-embedded role at a major pharmaceutical manufacturing facility or strategic positioning to serve the significant pharmaceutical manufacturing cluster in western Ireland, which includes major facilities from global pharmaceutical companies requiring specialized digital transformation expertise.
Consultancy environment emphasizing client delivery excellence, technical expertise, and regulatory compliance, likely offering exposure to diverse projects and clients while requiring high standards of professional service delivery and the ability to work effectively in client environments with varying organizational cultures and operational requirements
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