Internal Audit Manager

Tier4Group; Windsor (CO); On-site; USD 180,000 - 260,000; Full time

Job summary

Tier4 Group is seeking a Director of Labeling & Packaging Operations to lead and optimize labeling, inspection, assembly, packaging, and cartoning within a regulated manufacturing setting. You will drive safety, quality, productivity, and continuous improvement while building a high-performing team across multiple shifts.

The role requires a Bachelor’s in a relevant field, 10+ years in regulated manufacturing, and 5+ years of people leadership, with strong experience in labeling, packaging, and

Qualifications

• Experience in pharmaceutical/biotech/regulated manufacturing environments (cGMP, data integrity).
• Proven success leading multi-shift teams and establishing standards across products and lines.
• Strong ability to translate safety, quality, and performance data into actionable plans.

Responsibilities

• Lead labeling, inspection, assembly, packaging, and cartoning across products, technologies, and shifts.
• Ensure production schedules are executed safely, compliantly, and efficiently to meet commitments.
• Drive performance metrics: safety, quality, OEE, throughput, yield, labor productivity, and reliability.

Skills

Labeling operations

Packaging operations

GMP knowledge

Cross-functional leadership

People leadership

Process improvement

Education

Bachelor's degree in Engineering/Science

10+ years regulated manufacturing

5+ years leadership of leaders

Job description

Director, Labeling & Packaging Operations

Position 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.