cGMP Production Manager

Posted 16 Days Ago
Be an Early Applicant
Dublin, IRL
In-Office
Senior level
Pharmaceutical
The Role
Lead and execute cGMP secondary packaging and labeling operations, ensuring audit-ready batch execution, accurate MBR/EBR documentation, label/artwork control, ERP BOM maintenance, vendor coordination, regulatory alignment, and process improvement across global supply chain operations.
Summary Generated by Built In
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 individuals who 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/
 
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.  
 
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.  
 
For Your Safety, Please 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.
 
#LI-fulltime #LI-onsite

Skills Required

  • 8 years of experience in cGMP secondary packaging and labeling operations within pharmaceutical or clinical supply chain
  • Experience supporting clinical trial materials (preferred)
  • Strong working knowledge of cGMP requirements and global regulatory standards for packaging and labeling
  • Demonstrated expertise in label design, artwork development and proofing, MBR management, and packaging documentation with rigorous version control
  • Hands-on experience using ERP systems for production scheduling and BOM management
  • Proven ability to collaborate with Project Management, Regulatory, Quality, Procurement, and external suppliers
  • Strong vendor and stakeholder management capabilities focused on compliance and on-time delivery
  • Experience supporting and coordinating client and regulatory audits related to packaging and labeling
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The Company
HQ: Cary, NC
95 Employees
Year Founded: 2008

What We Do

We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.

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