Director, Labeling & Packaging Operations Direct HireOnsite - Windsor, COPosition Summary The Director, Labeling & Packaging Operations provides leadership and accountability for commercial labeling, inspection, assembly, packaging, and cartoning operations within a regulated manufacturing environment. This role is responsible for delivering safe, compliant, reliable, and efficient manufacturing performance while driving quality, productivity, workforce development, equipment reliability, and continuous improvement initiatives.
Key Responsibilities:
Lead labeling, inspection, assembly, packaging, and cartoning operations across multiple products, technologies, and shifts.
Ensure production schedules are executed safely, compliantly, and efficiently while meeting business and customer commitments.
Drive performance across safety, quality, OEE, throughput, yield, labor productivity, schedule attainment, and equipment reliability metrics.
Partner with Quality, Engineering, Maintenance, Automation, Validation, Supply Chain, and Regulatory teams to improve processes, resolve operational challenges, and support business objectives.
Provide leadership for investigations, deviations, CAPAs, change controls, audits, inspections, and regulatory compliance activities.
Support equipment qualification, validation, technology transfers, new product introductions, automation initiatives, and continuous improvement efforts.
Develop managers, supervisors, and manufacturing teams while building a culture of accountability, collaboration, and operational excellence.
Lead Lean, Six Sigma, TPM, and other improvement initiatives to enhance performance, reduce waste, and improve reliability.
Manage operating budgets, capital investments, staffing plans, and resource allocation.
Knowledge, Skills & Abilities:
Strong knowledge of pharmaceutical, biotechnology, medical device, or similarly regulated manufacturing environments, including cGMP, data integrity, and controlled production records.
Broad understanding of labeling, inspection, packaging, materials, equipment, automation, and quality controls applicable to regulated products.
Demonstrated success leading managers and multi-shift teams and establishing consistent standards across products, technologies, and work centers.
Ability to interpret safety, quality, schedule, OEE, capacity, cost, and workforce data and translate it into priorities, decisions, and executable plans.
Strong working knowledge of process control, equipment reliability, validation, change control, technology transfer, deviation investigation, CAPA, and risk management.
Proven track record of improving operational performance through structured problem solving, standard work, equipment-care systems, and continuous improvement methodologies.
Strong judgment and decision-making skills with the ability to balance compliance, quality, operational performance, and business priorities.
Effective communicator capable of influencing cross-functional stakeholders and representing Manufacturing during audits, inspections, and governance reviews.
Strategic, hands-on leadership style with the ability to manage ambiguity, competing priorities, and organizational change.
Education & Experience:
Bachelor's degree in Engineering, Science, Operations, Business, or a related discipline required; advanced degree preferred.10+ years of progressive experience in pharmaceutical, biotechnology, medical device, consumer health, or other regulated manufacturing environments, including significant manufacturing operations leadership experience.5+ years of people leadership experience, including leadership of leaders, multi-shift operations, or similarly complex manufacturing organizations. Experience leading labeling, inspection, packaging, assembly, serialization, or automated manufacturing operations strongly preferred. Demonstrated success improving operational performance, developing leadership and technical talent, and leading cross-functional change initiatives in regulated environments.
