Purpose and Scope
The Director Manufacturing – Labeling and Packaging provides end-to-end leadership and accountability for commercial labeling, visual inspection, device assembly, secondary packaging, and cartoning operations within Windsor Manufacturing. The role is responsible for safe, compliant, reliable, and efficient execution across a portfolio of products, technologies, and shifts, with accountability for schedule delivery, product quality, equipment performance, workforce capability, cost, and continuous improvement. The Director leads through managers and frontline leaders and partners closely with Quality, Engineering, Maintenance, Automation, MS&T, Validation, Supply Chain, Regulatory, and other functions to strengthen process control, resolve issues, deploy sustainable technical solutions, and prepare the organization for future demand and technology.
Essential Duties & Responsibilities
Operational Leadership
- Provide strategic and day-to-day leadership for labeling, visual inspection, assembly, tray-pack, and cartoning operations across assigned Windsor manufacturing areas.
- Own execution of the production schedule, aligning labor, equipment, materials, training, maintenance, and cross-functional support to meet business and patient-supply commitments.
- Establish consistent operating standards and performance-management routines across shifts, including tiered accountability, escalation, shift handoffs, leader floor presence, and effective use of controlled digital or visual-management systems.
- Monitor and improve safety, quality, schedule adherence, OEE, throughput, yield, cycle time, right-first-time, labor productivity, deviation, and equipment-reliability performance.
- Ensure labeling and packaging operations are inspection-ready and executed in accordance with approved procedures, product and component specifications, serialization requirements, in-process controls, and applicable regulatory commitments.
- Maintain clear ownership and timely escalation of constraints involving staffing, components, artwork, recipes, vision systems, inspection, equipment, or quality disposition that could affect schedule or supply.
Compliance & Regulatory
- Maintain a strong quality and compliance culture and ensure alignment with cGMP, data integrity, safety, labeling control, serialization, traceability, and applicable regulatory requirements.
- Provide Manufacturing leadership for deviations, investigations, risk assessments, change controls, and CAPA, emphasizing rapid containment, scientifically sound root cause, and sustainable engineering or system controls.
- Partner with Quality and Regulatory functions to ensure batch records, label and packaging documentation, recipes, electronic records, and quality-system actions are accurate, controlled, timely, and inspection-ready.
- Ensure operational tools, tier systems, job aids, and performance records have clear governance and do not create uncontrolled or parallel quality records.
- Represent Manufacturing during health authority inspections, customer audits, and internal governance reviews for labeling, inspection, packaging, and related quality-system matters.
Packaging Technology, Reliability & Process Support
- Partner with Engineering, Maintenance, Automation, MS&T, Validation, Quality, and suppliers to improve equipment condition, process capability, inspection effectiveness, and line reliability.
- Provide business ownership for labeling and packaging technologies, which may include vision and inspection systems, printers and coding, serialization, labelers, assembly equipment, thermoforming, cartoning, case packing, and material-handling systems.
- Support equipment qualification, validation, technology transfer, product launches, artwork or component changes, recipe changes, and implementation of new processes and technologies.
- Build sustainable autonomous-maintenance, troubleshooting, centerlining, standard-work, changeover, and equipment-care practices in partnership with technical functions.
- Sponsor automation and digital solutions that improve defect detection, data traceability, throughput, ergonomics, and operational control while maintaining appropriate validation and quality oversight.
People & Team Development
- Lead, coach, and develop managers, supervisors, technical specialists, leads, and operators, with clear accountability and a strong succession pipeline.
- Ensure training and qualification systems prepare employees to perform labeling, inspection, packaging, changeover, troubleshooting, and equipment-care activities safely, correctly, and consistently.
- Build technical depth and leadership capability across shifts through structured coaching, cross-training, skill matrices, development planning, and disciplined qualification.
- Create a culture of safety, quality, ownership, collaboration, urgency, problem solving, and timely escalation, with visible leadership on the manufacturing floor.
- Set expectations and hold leaders accountable for sustainable results while supporting employee engagement, retention, and change adoption.
Continuous Improvement & Strategy
- Develop and execute the labeling and packaging operating strategy, including capacity, staffing, shift structure, asset utilization, technology roadmap, and readiness for product growth or site transitions.
- Lead a prioritized improvement portfolio using OEE loss analysis, Lean, Six Sigma, standard work, SMED, TPM or comparable methods to reduce downtime, changeover time, manual constraints, defects, and waste.
- Strengthen line performance through effective task allocation, staffing to bottlenecks, operator capability, maintenance partnership, and sustained follow-through on corrective actions.
- Proactively identify operational, compliance, supply, equipment, and capability risks and establish mitigation plans with clear owners, resources, milestones, and escalation paths.
- Lead cross-functional initiatives that improve packaging reliability, inspection capability, scalability, business continuity, and cost competitiveness.
Financial & Resource Management
- Develop and manage operating and capital budgets for the labeling and packaging organization.
- Align headcount, shift coverage, qualification capacity, maintenance support, and technical resources with production demand and business priorities.
- Develop business cases and recommendations for equipment, automation, digital systems, facility, staffing, and process investments.
- Manage resources and external support to deliver sustainable operational and compliance outcomes.
- Perform other duties as assigned.
Core Values
This position is expected to operate within the framework of Tolmar’s Core Values:
- Center on People: We commit to support the well‑being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise‑wide mindset that lifts the whole organization.
- Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
- Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
- Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
- Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
Knowledge, Skills & Abilities
- Strong knowledge of pharmaceutical, biotechnology, medical-device, or similarly regulated manufacturing, 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.
- Track record of improving operational performance through structured problem solving, standard work, equipment-care systems, and practical continuous-improvement methods.
- Strong judgment and decision-making skills, including the ability to balance patient safety, compliance, supply, people, and business needs.
- Effective executive and frontline communicator who can influence cross-functional partners and represent Manufacturing during audits, inspections, and governance reviews.
- Strategic, hands-on, and adaptable 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.
- Ten or more years of progressive experience in pharmaceutical, biotechnology, medical-device, consumer-health, or similarly regulated manufacturing, including substantial experience in production operations.
- Five or more years of people-leadership experience, including leadership of leaders, multi-shift operations, or a comparably complex manufacturing organization.
- Experience leading labeling, inspection, packaging, assembly, serialization, or automated manufacturing operations is strongly preferred.
- Demonstrated experience improving operational performance, building leadership and technical capability, and leading cross-functional change in a regulated environment.
Working Conditions
- Working conditions are normal for an office environment. Some evenings and weekends may be necessary.
Compensation and Benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.