Director, Packaging and Manufacturing Operations

Position Summary

The Director, Packaging and Manufacturing Operations is the senior operations leader accountable for safe, compliant, reliable and cost-effective execution of clinical packaging and labeling activities at the Allentown site. The role provides strategic and day-to-day leadership across primary and secondary packaging operations, managing technical operation team, and works closely with Quality, Project Management, Engineering, Operational Excellence, Finance and other site functions to deliver customer commitments while maintaining cGMP compliance and a strong safety and quality culture.

Key Responsibilities

Operations Strategy & Execution

• Provide overall leadership for Packaging and Labeling Operations across all shifts, with accountability for safety, quality, service, productivity, cost and schedule performance.
• Translate site and business objectives into annual and multi-year departmental priorities, operating plans, resource requirements, budgets and measurable performance targets.
• Ensure production plans, labor, equipment and support resources are aligned to customer demand, backlog, capacity constraints and financial commitments; lead recovery plans when performance deviates from plan.
• Establish effective operating rhythms, including daily management boards, Gemba walks, performance reviews and escalation mechanisms that create visibility, accountability and timely decision-making.

Quality, Compliance & Risk

• Create and sustain a culture in which cGMP, SOP, data integrity, safety and regulatory requirements are embedded in daily operations and leadership behaviors.
• Ensure timely investigation, escalation and resolution of quality events, deviations, rejects and recurring operational issues in partnership with Quality; verify that corrective and preventive actions are effective and sustainable.
• Review and approve applicable SOPs, change controls and operational risk assessments; ensure risks, controls, owners and implementation plans are clearly defined.
• Maintain inspection and audit readiness within the organization and ensure leaders and employees are appropriately trained and qualified for assigned responsibilities.

People & Organizational Leadership

• Lead, coach and develop managers and leaders; set clear expectations, goals and accountability while building succession plans and a strong pipeline of operations talent.
• Develop staffing and organizational plans that match business demand, required capabilities and shift coverage; partner with Human Resources on workforce planning, performance management, employee relations and organizational effectiveness.
• Build an inclusive, engaged and high-performing culture characterized by ownership, disciplined execution, collaboration and continuous learning.
• Ensure consistent application of company policies and leadership standards throughout the organization.

Continuous Improvement, Engineering & Capital

• Own the operational excellence agenda for Packaging Operations and sponsor PPI/Lean initiatives that improve safety, quality, flow, right-first-time performance, labor productivity, equipment effectiveness, changeover performance and cost.
• Use data and root-cause problem solving to identify systemic constraints and recurring losses; prioritize improvement work based on business and customer impact.
• Define equipment, engineering and capital requirements needed to sustain compliance, increase capacity, improve reliability and enable business growth; develop business cases and ensure effective operational implementation.
• Partner with Engineering and technical functions on equipment lifecycle, process capability, new or changed processes, and operational readiness for upcoming projects.

Customer, Financial & Cross-Functional Leadership

• Partner with Project Management and other customer-facing functions to resolve operational questions, manage priorities and support dependable execution of client commitments.
• Provide clear, timely communication to the General Manager and site leadership on performance, risks, constraints and required decisions; present routine performance reporting for safety, quality, delivery, productivity and cost.
• Partner with Finance on budget management, backlog visibility, forecasting, productivity and capital planning; understand the operational drivers of site financial performance and take action to close gaps.
• Act as a senior site leader and cross-functional partner, balancing departmental priorities with overall site performance and patient/customer needs.
• Build strong, collaborative partnerships across site functions to drive alignment, enable effective decision-making, remove barriers and deliver shared site and business objectives.

Qualifications

• 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, food, chemical, cosmetics or other highly regulated manufacturing/packaging operations, with substantial experience in an FDA-regulated cGMP environment.
• Demonstrated experience leading through managers in a complex, multi-shift operations environment with accountability for safety, quality, delivery, cost and people performance.
• Experience leading Lean/PPI or comparable continuous improvement systems and delivering measurable, sustained operational improvement.
• Experience with capacity planning, workforce planning, budgeting, capital planning and cross-functional execution.
• Clinical packaging/labeling experience is strongly preferred.

Knowledge, Skills & Abilities

• Deep working knowledge of cGMP operations, quality systems, SOP governance, change control, deviation/investigation practices, CAPA and inspection/audit readiness.
• Strong operations leadership capability: converts strategy into priorities, establishes management systems, makes timely risk-based decisions and holds leaders accountable for results.
• Demonstrated ability to lead and develop managers, build succession depth, manage performance and create an engaged, accountable organization.
• Advanced problem-solving and continuous improvement capability, including use of data, root-cause analysis, standard work, visual management and Lean/PPI methods.
• Strong business and financial acumen, including understanding of labor and capacity drivers, productivity, backlog, budgets, forecasts, capital investment and cost tradeoffs.
• Ability to integrate competing customer and business priorities, manage ambiguity, and lead effectively through operational disruptions and change.
• Excellent written, verbal and executive communication skills; able to communicate clearly with frontline teams, technical functions, customers and senior leadership.
• Strong collaboration and influencing skills across Quality, Project Management, Engineering, Finance, HR, Supply Chain and other site/division partners.
• Working knowledge of packaging operations and equipment, production metrics and process capability sufficient to challenge assumptions, identify risk and guide technical/operational decisions.
• High standards of integrity, safety, quality, customer focus and personal accountability.

Preferred Qualifications

• Advanced degree in a relevant discipline.
• Lean/Six Sigma, operations, packaging, quality, supply chain or related professional certification.
• Experience in clinical trial supply packaging and labeling operations.
• Experience leading significant capital, capacity expansion, technology implementation or operational transformation initiatives.