Cristcot Management Company INC

Cristcot Management Company INC

Sr. Manager/Associate Director/Director, Packaging & Labeling Operations

Remote (United States) · Director

Sponsorship not specified$20k-$25kDetected 23 days ago
Product ManagementProject ManagementStakeholder ManagementForecastingBudgetingSupply ChainERPMechanical DesignGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingRegulatory Affairs

About the role

  • Cristcot 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 Cristcot's products.
  • Outside Cristcot: The Senior Manager / Associate Director / Director of Packaging & Labeling Operations will work with external CMOs, CDMOs, packaging vendors, labeling vendors, and kitting vendors.

Responsibilities

  • Reporting to senior leadership, this individual will provide strategic and operational oversight of packaging and labeling activities, manage internal and external stakeholders, and drive continuous improvement initiatives across the product lifecycle.
  • Depending on the level hired, the scope of responsibility may range from operational leadership of packaging and labeling functions to broader strategic ownership of packaging and labeling operations across multiple products, sites, or external partners.
  • The activities of the Packaging & Labeling Operations role will include, but are not limited to: Packaging and Labeling Operations 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.
  • 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.
  • Compliance and Quality Support launch readiness, change controls, deviations, CAPAs, risk assessments, and inspection readiness for packaging and labeling related activities.
  • Manage packaging, labeling, kitting, and serialization related vendors, including governance, issue resolution, timelines, and technical deliverables.

Requirements

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

Nice to have

  • Significant experience establishing and scaling packaging and labeling operations within a growth-stage or commercial organization.
  • 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 supporting late stage or commercial product launch preferred.
  • Combination product or drug device experience preferred.

Compensation

  • $20k-$25k

Benefits

  • Serve as the functional handoff point between CMC drug product, medical devices, supply chain, quality, regulatory, and external partners.

Company info

  • About Cristcot We are in the business of addressing the problem within the problem.
  • We focus on the details and connections that other, major pharma companies have left ignored for years.
  • There are better ways, better drugs and better formulations and we will make them a reality by analyzing, understanding and solving the problems within the problems.

Visa & Work Authorization

  • Provide sponsor side oversight of serialization readiness and execution at CMO.
Apply directly at Cristcot Management Company INC →Create a free account for alerts like thisView Cristcot Management Company INC immigration profile

This listing is sourced directly from Cristcot Management Company INC's careers page and normalized into a canonical job model.