Cristcot logo
Cristcot

The work that we do today will impact the lives, of people we do not know, in a humanistic way.

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

Location

United States

Posted

20 hours ago

Salary

0

Seniority

Senior

Bachelor Degree8 yrs expEnglishERP

Job Description

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

Cristcot

• 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.

Job 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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