cGMP Production Manager

WEP Clinical Ltd; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Group Private Medical Insurance

Group General Life Assurance

Group Critical Illness and Group In‑s

Salary sacrifice pension scheme

Enhanced maternity & paternity pay

Educational Assistance allowance

Paid volunteering day

Job summary

WEP Clinical Ltd in Ireland is seeking a cGMP Production Manager to lead hands-on production, packaging, and labeling activities while ensuring audit-ready operations. You will manage room setup, batch execution, documentation, and labeling controls, working with cross-functional teams across Global Supply Chain Operations.

The role requires deep knowledge of GMP/GDP standards, MBR/EBR control, and ERP-driven BOM management, with a focus on process optimization and global standardization

Qualifications

• 8 years of experience in cGMP secondary packaging and labeling in pharma or clinical supply.
• Strong knowledge of cGMP requirements and global pharma packaging standards.
• Experience with label design, artwork, MBR/EBR, and documentation with version control.

Responsibilities

• Execute and oversee GMP production activities, including room setup, batch execution, in-process checks, reconciliation, line clearance, and clean-down.
• Maintain production suites in a continuous audit-ready state, ensuring compliance with GMP, GDP, SOPs, and quality standards.
• Serve as a global production SME, providing real-time troubleshooting, escalation support, and technical guidance during operations.
• Verify readiness and compliance of materials, labels, packaging components, equipment, and documentation prior to batch execution.
• Create, review, and maintain MBRs and EBRs, ensuring accurate, timely, and compliant batch documentation.
• Develop, proof, issue, control, and reconcile label templates, artwork, and packaging layouts to meet regulatory, client, and protocol requirements.
• Partner with Project Management, Regulatory, and Quality to finalize packaging and labelling designs, layout drawings, samples, and client approvals.
• Maintain BOMs and related master data in ERP systems, ensuring accurate configuration, versioning, and updates.
• Support vendor coordination, sourcing decisions, and supplier qualification for packaging components, tooling, consumables, and equipment.
• Drive process optimization, change controls, system enhancements, and global standardization initiatives across Production and Global Supply Chain Operations.

Skills

Strategic thinking

Collaborative

Proactive

Adaptable

Strong problem-solving

Vendor & stakeholder management

Cross-functional collaboration

Tools

ERP systems

Job description

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.

Role Objectives:

The WEP Clinical cGMP Production Manager is responsible for both hands-on execution and technical expertise of production, packaging, and labeling activities, ensuring compliant, efficient, and audit-ready operations. The role oversees end-to-end GMP batch execution, including room setup, documentation accuracy, component readiness, labeling, artwork control, and MBR/EBR ownership, while also supporting packaging design, regulatory alignment, material specification development, and client approvals. In addition to leading daily production activities, the role contributes to process optimization, change controls, system improvements, and cross‑functional initiatives across Global Supply Chain Operations. Acting as a production and labeling SME, the cGMP Production Manager supports the implementation of global processes, collaborates with Project Management, Regulatory, Quality, Warehouse, Logistics, and Procurement teams, and participates in vendor coordination and audits to ensure high-quality, efficient, and standardized operational performance.

The Ideal Candidate:

• Strategic
• Collaborative
• Proactive
• Adaptable

What You'll Do:

• Execute and oversee GMP production activities, including room setup, batch execution, in-process checks, reconciliation, line clearance, and clean-down.
• Maintain production suites in a continuous audit-ready state, ensuring compliance with GMP, GDP, SOPs, and quality standards.
• Serve as a global production SME, providing real-time troubleshooting, escalation support, and technical guidance during operations.
• Verify readiness and compliance of materials, labels, packaging components, equipment, and documentation prior to batch execution.
• Create, review, and maintain MBRs and EBRs, ensuring accurate, timely, and compliant batch documentation.
• Develop, proof, issue, control, and reconcile label templates, artwork, and packaging layouts to meet regulatory, client, and protocol requirements.
• Partner with Project Management, Regulatory, and Quality to finalize packaging and labelling designs, layout drawings, samples, and client approvals.
• Maintain BOMs and related master data in ERP systems, ensuring accurate configuration, versioning, and updates.
• Support vendor coordination, sourcing decisions, and supplier qualification for packaging components, tooling, consumables, and equipment.
• Drive process optimization, change controls, system enhancements, and global standardization initiatives across Production and Global Supply Chain Operations.

What You'll Need:

• 8 years of experience in cGMP secondary packaging and labeling operations within the pharmaceutical or clinical supply chain environment, preferably supporting clinical trial materials
• Strong working knowledge of cGMP requirements and global regulatory standards governing pharmaceutical packaging and labeling
• Demonstrated expertise in label design, artwork development and proofing, MBR management, and packaging documentation, with rigorous version control and attention to detail
• Hands-on experience using ERP systems to support production scheduling, Bill of Materials (BOM) management, and operational workflow optimization
• Proven ability to think strategically, solve complex operational challenges, and collaborate effectively with cross-functional partners including Project Management, Regulatory Affairs, Quality Assurance, Procurement, and external suppliers
• Strong vendor and stakeholder management capabilities, with a consistent focus on compliance, accuracy, and on-time delivery
• Experience supporting and coordinating client and regulatory audits related to packaging and labeling activities

What We Offer:

• Group Private Medical Insurance
• Group General Life Assurance
• Group Critical Illness and Group Income Protection
• Salary sacrifice pension scheme
• Enhanced maternity & paternity pay
• Educational Assistance allowance
• Paid volunteering day

What Sets Us Apart:

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn life page to learn more about our team events and all that we do to support our employees.

How We Work at WEP Clinical:

At WEP Clinical, we look for individualswho are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives – and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services Include:

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialisation

Data Privacy Notice:

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

Privacy Policy: https://www.wepclinical.com/privacy-policy/

Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.