Manager Artwork Development QC

The role of the Medical Office is to bring medical, regulatory, scientific and drug safety related insights and expertise to

• Own and oversee end-to-end artwork development QC of packaging and product information artwork, from brief and source content through final approval.
• Perform independent input-to-output verification to confirm that final artwork accurately reflects regulatory content and technical specifications.
• Lead detailed content QC against approved regulatory source documents, including indications, dosing, warnings, contraindications, storage conditions, legal statements, manufacturer details, pharmacovigilance wording, references and market-specific requirements.
• Perform design and technical QC covering layout, hierarchy, legibility, typography, colour, symbols, barcode/GTIN placement, dimensions, dielines, print specifications, component identification and consistency across pack components.
• Confirm alignment with approved dossier, labelling and regulatory commitments, with traceability to an approved change control, variation, renewal, safety update or business requirement.
• Ensure change control, deviations, exceptions, risk assessments and artwork decisions are appropriately recorded, escalated and closed.
• Perform QC for artworks of components and progress the relevant workflows timely, ensuring entire QC task are completed on time as be business needs.
• Use electronic proofreading tools, where applicable and interpret results in conjunction with manual visual inspection.
• Plan and manage multiple concurrent artwork projects across markets, products, components, suppliers and implementation dates using clear scope, milestones, dependencies, owners and risk controls.
• Lead kick-off meetings, working sessions, review cycles, issue-resolution meetings and approval forums; ensure decisions, actions and due dates are documented.
• Use metrics such as cycle time, right-first-time performance, review turnaround, overdue actions, rework and deviation trends on-time delivery to drive performance.
• Serve as a subject-matter expert in pharmaceutical packaging, labelling, regulatory artwork expectations, good documentation practices and controlled change management.
• Understand the relationship between artwork, regulatory submissions, approvals, post-approval changes, implementation dates, manufacturing readiness and product supply.
• Monitor and implement relevant guidance, company standards and market requirements affecting packaging content, readability, safety information, symbols, barcodes and implementation.
• Maintain and improve artwork SOPs, work instructions, checklists, RACI models, review standards, support continuous improvements and training materials by taking ownership.
• Ensure artwork records, metadata, component relationships, approvals, source files complete and accurate in approved artwork and document management systems.
• Partner with system owners to identify configuration, workflow, reporting and automation opportunities that improve quality control, visibility and reviewer productivity.
• Establish risk-based QC approaches for routine, complex, urgent and high-impact artwork changes while maintaining independent review and segregation of duties.
• Lead root-cause analysis for recurring errors, classify artwork defects and implement preventive actions, standardization, lessons learned and targeted training.
• Act as line manager for Artwork QC team, set objective, review performance, RFT, rework monitoring, QC KPIs and responsible for development of the Artwork QC team.Coach and develop artwork QC reviewers and coordinators; proofreader training to team, competency assessment, build capability in regulatory content review, design fundamentals, technical specifications, qualification/sign-off and ongoing requalification and good documentation practices.
• Set clear quality expectations, review performance, allocate work and promote a culture of ownership, challenge and timely escalation.
• Manage collaboration with artwork developers, CMOs and system technology vendors; ensure deliverables, quality standards and issue resolution are controlled.
• Build trusted relationships across Regulatory Affairs, Quality, Supply Chain, Manufacturing, Commercial and local affiliates while maintaining independent quality judgement.
• Represent Artwork Development QC in cross-functional projects, inspections, audits and senior-management reviews

• 1 Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, Packaging Technology.
• 2 Project Management certification
• 1 8–10 years of relevant experience in pharmaceutical/regulatory artwork QC, packaging operations, regulatory labelling, pharmaceutical design production or a closely related regulated environment.
• 2 Hands-on experience reviewing both regulated content and visual/technical artwork quality, with evidence of strong error detection and risk-based judgement.
• 3 Experience working with CMOs and cross-functional global teams.
• 1 Experience with Adobe Acrobat Pro, Microsoft Word, Microsoft Excel
• 2 Experience on MAC OS
• 3 Experience working on Electronic proofreading tools, preferably with GlobalVision
• 3 Working knowledge of controlled document systems and artwork management platforms; experience with Veeva Vault RIM/AMS or comparable systems.
• 4 Artwork and design QC, Regulatory content QC, Project management, Pharma domain expertise, Systems and data
• 5 People Management Experience
• 6 Must be able to visually distinguish between colours
• 1 Excellent interpersonal, communication, organizational skills and attention to detail should be must
• 2 Continuous Improvement Mindset
• 3 Time management
• 4 Ability to work under pressure, ability to prioritise task for self and team based on business priority