Senior Manager/Associate Director/Director, Packaging & Labeling Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee both strategic and operational aspects of packaging and labeling activities.

• Collaborate with internal and external stakeholders effectively.

• Propel continuous improvement initiatives throughout the product lifecycle.

• Direct packaging and labeling operations to facilitate clinical, commercial, and post-market activities.

• Spearhead packaging validation, shipping validation, and the strategy and execution oversight of drop tests.

• Ensure compliance of packaging and labeling processes with relevant FDA, ISO, MDR, and other global regulatory standards.

• Provide technical oversight from the sponsor's perspective for primary packaging, labeling, artwork, printed packaging components, and commercial kitting of drug products and device components.

• Develop, maintain, and oversee the approval and implementation of packaging and labeling specifications, procedures, and documentation.

• Collaborate with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Product Development teams to ensure alignment throughout product lifecycle activities.

• Assist with product launches, design modifications, market expansions, and supply continuity efforts.

• Oversee serialization readiness and execution from the sponsor's side at the CMO.

• Manage vendors related to packaging, labeling, kitting, and serialization, including governance, issue resolution, timelines, and technical deliverables.

• Ensure that packaging and labeling activities adhere to established quality systems and applicable regulations.

• Investigate any deviations, nonconformances, CAPAs, and labeling-related quality issues.

• Assess and mitigate operational and compliance risks linked to packaging and labeling activities.

• Lead cross-functional projects focused on packaging optimization, labeling implementation, product launches, and process enhancements.

• Create and monitor key performance indicators (KPIs) for packaging and labeling operations.

• Set priorities, allocate resources, and ensure the timely execution of operational objectives.

⛳️ Requirements

• A Bachelor’s degree in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Supply Chain, Life Sciences, or a related field is required.

• An advanced degree (MS, MBA, or equivalent) is preferred.

• For Senior Manager: A minimum of 8 years of experience in biotechnology, pharmaceuticals, medical devices, or other regulated healthcare sectors, with at least 3 years of direct experience in managing packaging and/or labeling operations.

• For Associate Director: At least 10 years of experience in biotechnology, pharmaceuticals, medical devices, or other regulated healthcare industries, with a minimum of 5 years of leadership experience in packaging, labeling, manufacturing operations, supply chain, or related functions.

• For Director: A minimum of 12 years of experience in biotechnology, pharmaceuticals, medical devices, or other regulated healthcare sectors, including at least 7 years of progressive leadership experience with responsibilities for teams, budgets, and strategic initiatives.

• Experience working with external CMOs, CDMOs, packaging vendors, labeling vendors, and kitting vendors.

• Familiarity with FDA-regulated and/or ISO 13485 environments.

• Strong knowledge of cGMP, packaging validation, shipping validation, labeling controls, artwork processes, and DSCSA governance.

• Proven experience in leading cross-functional projects and managing external vendors or contract manufacturers.

• A solid understanding of quality systems, document control, change management, and regulatory compliance.

• Experience engaging with executive leadership, regulatory agencies, and external partners.

• Prior experience supporting late-stage or commercial product launches is preferred.

• Experience with combination products or medical devices is advantageous.

• Familiarity with ERP, PLM, document management, and quality management systems.

• Exceptional project management and organizational skills.

• Strong analytical and problem-solving abilities.

• Capacity to thrive in a fast-paced, growth-oriented environment.

• Demonstrated leadership, collaboration, and stakeholder management capabilities.

• Willingness to travel 20-25% of the time.

🏝️ Benefits

• Health insurance

• 401(k)

• Paid time off

• Flexible working arrangements

• Professional development opportunities