cGMP Production Manager

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

Benefits offered by this job

Medical Insurance

Life Assurance

Critical Illness and Income Protection

Pension - Salary sacrifice

Maternity/Paternity pay

Education Allowance

Volunteer Day

Job summary

WEP Clinical is seeking a cGMP Production Manager in Ireland to lead hands-on GMP production, packaging and labeling activities within the clinical supply chain. You will ensure audit-ready operations, accurate documentation and cross-functional collaboration across Global Supply Chain Operations.

Ideal candidates bring 8+ years in cGMP packaging/labeling, expertise in label design and MBR/EBR management, and strong ERP/BOM experience to drive process improvements and vendor coordination across

Qualifications

• 8 years of experience in cGMP secondary packaging and labeling operations within pharmaceutical or clinical supply chain environments.
• Strong working knowledge of cGMP requirements and global regulatory standards for pharmaceutical packaging and labeling.
• Expertise in label design, artwork development and proofing, MBR management, and packaging documentation with strict version control.
• Hands-on experience using ERP systems to support production scheduling, BOM management, and workflow optimization.
• Proven ability to think strategically, solve complex operational challenges, and collaborate with cross-functional teams.
• Strong vendor and stakeholder management with focus on compliance, accuracy and on-time delivery.
• Experience supporting client and regulatory audits related to packaging and labeling.

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 an audit-ready state, ensuring GMP, GDP, SOPs and quality standards compliance.
• Provide real-time troubleshooting and guidance as a global production SME during operations.
• Verify readiness of materials, labels, packaging components, equipment and documentation before batch execution.
• Create, review and maintain MBRs/EBRs with accurate, timely 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 designs and client approvals.
• Maintain BOMs and master data in ERP systems with accurate versioning.
• Support vendor coordination, sourcing decisions and supplier qualification for packaging components and equipment.
• Drive process optimization, change controls and global standardization across Production and Global Supply Chain Operations.

Skills

cGMP

Packaging

Labeling

ERP systems

BOM management

Project management

Regulatory affairs

Quality assurance

Procurement

Audits

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/

Important Note:

We will never communicate with you via Microsoft Teams or text message

We will never ask for your bank account information at any stage of recruitment.

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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.