Director, Packaging & Labeling Operations

Cristcot

About The Position

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. Working with internal and external stakeholders, this person will lead the creation and execution of all packaging activities, including design, validation, artwork, and execution at Cristcot’s CMO. Primary Relationships: Within Cristcot: The Senior Manager / Associate Director / Director of Packaging & Labeling Operations will collaborate with Manufacturing, Quality, Compliance, Regulatory, and Legal. 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. Primary Job 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. 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. Compliance and Quality Support launch readiness, change controls, deviations, CAPAs, risk assessments, and inspection readiness for packaging and labeling related activities. 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. Serve as the functional handoff point 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-related quality events. Assess and mitigate operational and compliance risks associated with packaging and labeling activities. Leadership and Project Management 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. Manage external vendors, consultants, and strategic partners as applicable. Strategic Planning Contribute to budgeting, forecasting, resource planning, and organizational development activities. Provide leadership with recommendations regarding packaging and labeling capabilities, investments, and risk management.

Requirements

Bachelor’s degree in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Supply Chain, Life Sciences, or related field required.
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 with ERP, PLM, document management, and quality management systems.
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.

Nice To Haves

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. Significant experience establishing and scaling packaging and labeling operations within a growth-stage or commercial organization.
Experience supporting late stage or commercial product launch preferred.
Experience with combination products or medical devices preferred.
Combination product or drug device experience preferred.

Responsibilities

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.
Support launch readiness, change controls, deviations, CAPAs, risk assessments, and inspection readiness for packaging and labeling related activities.
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.
Serve as the functional handoff point 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-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.
Manage external vendors, consultants, and strategic partners as applicable.
Contribute to budgeting, forecasting, resource planning, and organizational development activities.
Provide leadership with recommendations regarding packaging and labeling capabilities, investments, and risk management.