[Remote] Sr. Manager/Associate Director/Director, Packaging & Labeling Operations

Note: The job is a remote job and is open to candidates in USA. 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 and will lead the creation and execution of all packaging activities, including design, validation, artwork, and execution at Cristcot’s CMO.ResponsibilitiesLead packaging and labeling operations to support clinical, commercial, and post-market activitiesLead packaging validation, shipping validation, and drop test strategy and execution oversightEnsure packaging and labeling processes comply with applicable FDA, ISO, MDR, and other global regulatory requirementsOwn sponsor side technical oversight for primary packaging, labeling, artwork, printed packaging components, and commercial kitting of drug product and device componentsDevelop and maintain approval, implementation, and control of packaging and labeling specifications, procedures, and documentationPartner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Product Development teams to ensure alignment across product lifecycle activitiesSupport product launches, design changes, market expansions, and supply continuity initiativesSupport launch readiness, change controls, deviations, CAPAs, risk assessments, and inspection readiness for packaging and labeling related activitiesProvide sponsor side oversight of serialization readiness and execution at CMOManage packaging, labeling, kitting, and serialization related vendors, including governance, issue resolution, timelines, and technical deliverablesServe as the functional handoff point between CMC drug product, medical devices, supply chain, quality, regulatory, and external partnersEnsure packaging and labeling activities are performed in accordance with established quality systems and applicable regulationsInvestigate deviations, nonconformances, CAPAs, and labeling-related quality eventsAssess and mitigate operational and compliance risks associated with packaging and labeling activitiesLead cross-functional projects related to packaging optimization, labeling implementation, product launches, and process improvementsDevelop and monitor key performance indicators (KPIs) for packaging and labeling operationsEstablish priorities, allocate resources, and ensure timely execution of operational objectivesManage external vendors, consultants, and strategic partners as applicableContribute to budgeting, forecasting, resource planning, and organizational development activitiesProvide leadership with recommendations regarding packaging and labeling capabilities, investments, and risk managementSkillsBachelor's degree in Packaging Engineering, Chemical Engineering, Mechanical Engineering, Materials Science, Supply Chain, Life Sciences, or related field requiredSenior 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 operationsAssociate 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 functionsDirector: 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 organizationExperience with external CMOs, CDMOs, packaging vendors, labeling vendors, and kitting vendorsExperience working within FDA-regulated and/or ISO 13485 environmentsStrong knowledge of cGMP, packaging validation, shipping validation, labeling controls, artwork processes, and DSCSA governanceDemonstrated experience leading cross-functional projects and managing external vendors or contract manufacturersStrong understanding of quality systems, document control, change management, and regulatory complianceExperience interacting with executive leadership, regulatory agencies, and external partnersExcellent project management and organizational skillsStrong analytical and problem-solving capabilitiesEffective written and verbal communication skillsAbility to work effectively in a fast-paced, growth-oriented environmentDemonstrated leadership, collaboration, and stakeholder management skillsAbility to travel 20-25%Advanced degree (MS, MBA, or equivalent) preferredExperience supporting late stage or commercial product launch preferredExperience with combination products or medical devices preferredCombination product or drug device experience preferredExperience with ERP, PLM, document management, and quality management systemsCompany OverviewCristcot focuses on drug delivery systems that combine products and specialty drug formulations. It was founded in 2008, and is headquartered in Concord, Massachusetts, USA, with a workforce of 11-50 employees. Its website is https://www.cristcot.com.