Senior Manager/Associate Director/Director, Packaging & Labeling Operations
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Job Description
Senior Manager / Associate Director / Director of Packaging and Labeling Operations at Cristcot. Overseeing packaging and labeling activities to ensure compliance and support product supply.
Responsibilities:
- Provide strategic and operational oversight of packaging and labeling activities.
- Manage internal and external stakeholders.
- Drive continuous improvement initiatives across the product lifecycle.
- Lead packaging and labeling operations to support clinical, commercial, and post-market activities.
- Lead packaging validation, shipping validation, and drop test strategy and execution oversight.
- Ensure packaging and labeling processes comply with applicable FDA, ISO, MDR, and other global regulatory requirements.
- Own sponsor side technical oversight for primary packaging, labeling, artwork, printed packaging components, and commercial kitting of drug product and device components.
- Develop 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.
- Provide sponsor side oversight of serialization readiness and execution at CMO.
- Manage packaging, labeling, kitting, and serialization related vendors, including governance, issue resolution, timelines, and technical deliverables.
- Ensure packaging and labeling activities are performed in accordance with established quality systems and applicable regulations.
- Investigate deviations, nonconformances, CAPAs, and labeling-related quality events.
- Assess and mitigate operational and compliance risks associated with packaging and labeling activities.
- Lead cross-functional projects related to packaging optimization, labeling implementation, product launches, and process improvements.
- Develop and monitor key performance indicators (KPIs) for packaging and labeling operations.
- Establish priorities, allocate resources, and ensure timely execution of operational objectives.
Requirements:
- Bachelor’s degree in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Supply Chain, Life Sciences, or related field required.
- Advanced degree (MS, MBA, or equivalent) preferred.
- Senior Manager: 8+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated healthcare 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 healthcare industries with 5+ years of leadership experience in packaging, labeling, manufacturing operations, supply chain, or related functions.
- Director: 12+ years of experience in biotechnology, pharmaceutical, medical device, or other regulated healthcare industries with 7+ years of progressive leadership experience, including responsibility for teams, budgets, and strategic initiatives.
- Experience with external CMOs, CDMOs, packaging vendors, labeling vendors, and kitting vendors.
- Experience working within 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.
- Experience supporting late stage or commercial product launch preferred.
- Experience with combination products or medical devices preferred.
- Experience with ERP, PLM, document management, and quality management systems.
- Excellent project management and organizational skills.
- Strong analytical and problem-solving capabilities.
- Ability to work effectively in a fast-paced, growth-oriented environment.
- Demonstrated leadership, collaboration, and stakeholder management skills.
- Ability to travel 20-25%.
Benefits:
- Health insurance
- 401(k)
- Paid time off
- Flexible working arrangements
- Professional development opportunities
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