Pharmaceutical Labeling & Compliance Systems Lead

NCC Talent Solutions, LLC; San Diego (CA); On-site; USD 41,000 - 48,000; Full time

Job summary

NCC Talent Solutions, LLC seeks a Pharmaceutical Labeling & Compliance Systems Lead to support labeling, facility systems, and regulatory compliance across manufacturing operations. You’ll work with Engineering, Regulatory Affairs, Quality, IT, and external partners to ensure adherence to FDA and global requirements.

The role emphasizes cross-functional project leadership, change control, and implementing labeling standards such as UDI and GS1.

Qualifications

• Knowledge of pharmaceutical labeling, serialization, and change control.
• Experience in FDA-regulated drug manufacturing environments.
• Ability to lead cross-functional projects and manage stakeholders.

Responsibilities

• Develop, implement, and maintain labeling for new product development and quality initiatives.
• Coordinate with Regulatory Affairs, Quality, Manufacturing, and contract manufacturers on labeling.
• Lead labeling activities for product launches and market expansions.
• Own design change controls and related documentation for labeling and facility changes.
• Ensure compliance with FDA, GMP, GDP, GLP and related quality systems.

Tools

Labeling software

Document management system

Microsoft Office

Visio

Project

Job description

We are seeking aPharmaceutical Labeling & Compliance Systems Leadto support our clients pharmaceutical manufacturing operations and ensure that labeling, facility systems, computerized infrastructure, and related processes remain compliant with applicable FDA and global regulatory requirements.

This is a highly cross-functional role that works closely withEngineering, Construction, Maintenance, Calibration, Regulatory Affairs, Quality, Supply Chain, R&D, Manufacturing, IT, and external customers/partners. The ideal candidate brings a strong understanding of pharmaceutical manufacturing, regulated quality systems, labeling requirements, and change control, along with the ability to lead projects from concept through implementation.

Anticipated pay range is $30 - $35 an hour.

What You'll Do

Pharmaceutical Labeling & Serialization

• Develop, implement, and maintain labeling for new product development, product support, quality initiatives, and business needs.
• Manage labeling content and specifications, including serialization, dimensions, barcodes, language translations, typography, font size, symbols, wording, formatting, and overall conformity.
• Coordinate with Regulatory Affairs, Quality, Manufacturing, customers, and contract manufacturers to develop, review, approve, and implement labeling.
• Support pharmaceutical serialization and applicable labeling standards, includingUDI, EU MDR, GS1, ISBT-128, and HIBC-128.
• Monitor changes to labeling regulations and standards and perform gap assessments and remediation planning to maintain compliance.
• Lead labeling activities associated with new product launches, market expansion, distributor/address changes, and other cross-functional initiatives.
• Support facility compliance within a regulated pharmaceutical manufacturing environment.
• Own and coordinateDesign Change Controls, Change Orders, and related documentationfor labeling, IT, facility improvements, and modifications.
• Lead cross-functional projects, develop project schedules, coordinate deliverables, and communicate project status to stakeholders.
• Partner with R&D and Engineering teams to implement new products and product/process changes.
• Work with Regulatory and Quality teams to assess regulatory impacts and develop appropriate implementation and remediation plans.
• Ensure activities are conducted in accordance with applicableFDA, GMP, GDP, GLP, and regulated Quality Systemrequirements.

Systems & Infrastructure

• Support and maintain the computerized systems and digital infrastructure required to operate a compliant pharmaceutical manufacturing or laboratory environment.
• Coordinate IT-related requirements associated with labeling, manufacturing systems, facility infrastructure, and business operations.
• Support user computing equipment, email, data backup/archive systems, VPN connectivity, network interconnectivity, and infrastructure supporting manufacturing areas and facilities.
• Support the implementation and maintenance of compliant computerized systems and documentation management systems.

What You Bring

• 3-5 years of experience in pharmaceutical manufacturing, preferably inRX injectables and/or aseptic processing.
• Experience working in anFDA-regulated drug manufacturing environment.
• Working knowledge of FDA and global requirements related to pharmaceutical labeling, serialization, and barcoding.
• Familiarity with standards such asUDI, EU MDR, GS1, ISBT-128, and HIBC-128.
• Strong understanding ofCFR,GMP, GDP, GLP, and regulated Quality Systems.
• Experience withchange control, design change control, document control, design verification/validation, and regulatory approval processes.
• Experience with labeling software and documentation management systems.
• Demonstrated ability to lead cross-functional projects, establish project schedules, manage competing priorities, and communicate effectively with stakeholders.
• Strong critical-thinking, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively across a global organization and with internal and external stakeholders.
• Proficiency withMicrosoft Office, including Word, Excel, PowerPoint, Project, and Visio.

This role offers the opportunity to have a direct impact onpharmaceutical manufacturing compliance, product labeling, facility systems, and new product implementation. You will work across multiple functions and help drive projects that support both day-to-day operations and future business growth.

If you enjoy working at the intersection ofregulatory compliance, pharmaceutical manufacturing, technology, labeling, and cross-functional project leadership, we'd like to hear from you.