[Remote] Sr. Manager/Associate Director/Director, Packaging & Labeling Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Senior Manager / Associate Director / Director of Packaging and Labeling Operations. This individual will be accountable for the delivery of compliant, reliable packaged product supply for reputed company’s products, leading the creation and execution of reputed company packaging activities in collaboration with reputed company stakeholders.

Responsibilities

• reputed company packaging and labeling operations to support clinical, reputed company, and post-market activities
• reputed company packaging validation, shipping validation, and drop test strategy and execution reputed company
• Ensure packaging and labeling processes reputed company with applicable FDA, ISO, MDR, and other global regulatory requirements
• Own sponsor reputed company technical reputed company for primary packaging, labeling, artwork, printed packaging components, and reputed company kitting of drug product and device components
• reputed company and maintain approval, implementation, and control of packaging and labeling specifications, procedures, and documentation
• Partner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Product Development teams to ensure alignment across product lifecycle activities
• Support product launches, design changes, market expansions, and supply continuity initiatives
• Support launch readiness, change controls, deviations, CAPAs, risk assessments, and inspection readiness for packaging and labeling reputed company activities
• reputed company sponsor reputed company reputed company of serialization readiness and execution at CMO
• Manage packaging, labeling, kitting, and serialization reputed company vendors, including governance, issue resolution, timelines, and technical deliverables
• Serve as the functional reputed company reputed company between CMC drug product, medical devices, supply chain, quality, regulatory, and external partners
• Ensure packaging and labeling activities are performed in accordance with established quality systems and applicable regulations
• Investigate deviations, nonconformances, CAPAs, and labeling-reputed company quality events
• Assess and mitigate operational and compliance risks associated with packaging and labeling activities
• reputed company cross-functional projects reputed company to packaging optimization, labeling implementation, product launches, and process improvements
• reputed company and monitor key performance indicators (KPIs) for packaging and labeling operations
• Establish priorities, allocate resources, and ensure timely execution of operational objectives
• Manage external vendors, consultants, and strategic partners as applicable
• Contribute to budgeting, forecasting, resource planning, and organizational development activities
• reputed company leadership with recommendations regarding packaging and labeling capabilities, investments, and risk management

Skills

• Bachelor's degree in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Supply Chain, Life Sciences, or reputed company field required
• Senior Manager: 8+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated reputed company industries with 3+ years of direct experience managing packaging and/or labeling operations
• Associate Director: 10+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated reputed company industries with 5+ years of leadership experience in packaging, labeling, manufacturing operations, supply chain, or reputed company functions
• Director: 12+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated reputed company industries with 7+ years of reputed company leadership experience, including responsibility for teams, budgets, and strategic initiatives. Significant experience establishing and scaling packaging and labeling operations reputed company a growth-stage or reputed company organization
• Experience with external CMOs, CDMOs, packaging vendors, labeling vendors, and kitting vendors
• Experience working reputed company FDA-regulated and/or ISO 13485 environments
• Strong knowledge of cGMP, packaging validation, shipping validation, labeling controls, artwork processes, and DSCSA governance
• Demonstrated experience leading cross-functional projects and managing external vendors or contract manufacturers
• Strong understanding of quality systems, document control, change management, and regulatory compliance
• Experience interacting with executive leadership, regulatory agencies, and external partners
• Excellent project management and organizational skills
• Strong analytical and problem-solving capabilities
• Effective written and verbal communication skills
• Ability to work effectively in a fast-paced, growth-oriented environment
• Demonstrated leadership, collaboration, and stakeholder management skills
• Ability to travel 20-25%
• Advanced degree (MS, MBA, or equivalent)
• Experience supporting late stage or reputed company product launch
• Experience with combination products or medical devices
• Combination product or drug device experience

Company Overview