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Purpose and Scope

The Manager Operational Excellence is a member of the Corporate Operational Excellence organization and provides leadership for implementing and sustaining a continuous improvement culture across cGMP-regulated pharmaceutical manufacturing operations. This role drives operational excellence in a manner that strengthens quality systems, improves process capability and reliability, supports inspection readiness, and advances patient safety, supply continuity, and cost performance.

The OpEx Manager partners with the VP Business Strategy/CI and site leadership to lead cultural change using Lean and Six Sigma tools within a regulated manufacturing environment. This role also provides direct leadership to the Operational Excellence team, including setting priorities, developing capability, and ensuring resources are aligned to the highest-value initiatives. The role works cross-functionally with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Supply Chain, and Regulatory teams to simplify processes, reduce waste and variation, improve right-first-time performance, shorten cycle times, strengthen batch release performance, and embed the Tolmar Operating System throughout the organization.

Essential Duties & Responsibilities

• Lead and facilitate operational excellence initiatives across pharmaceutical manufacturing and support functions, ensuring alignment with cGMP requirements, quality standards, and business priorities.
• Directly supervise the Operational Excellence team, including hiring, onboarding, coaching, performance management, development planning, succession planning, and day-to-day prioritization of resources and deliverables.
• Identify and prioritize improvement opportunities that enhance safety, quality, delivery, inventory, and cost performance while maintaining validated state and compliance.
• Partner with Manufacturing, Quality, Engineering, Validation, Supply Chain, and other functions to improve process flow, equipment utilization, capacity, and schedule adherence.
• Support site and functional diagnostics to assess current-state performance; establish data collection methods, KPIs, and visual management systems to monitor progress and sustain gains.
• Facilitate Kaizen events, value stream mapping, Gemba walks, and root cause problem-solving workshops focused on reducing deviations, rework, scrap, downtime, and cycle time.
• Assist in the development and execution of tactical improvement plans, including resource needs, timelines, risk mitigation, and change management actions.
• Apply and promote continuous improvement tools and systems, including 5S, visual management, standard work, DMAIC, control plans, mistake proofing, 5 Whys, and CAPA-related root cause analysis.
• Track the performance and maturity of improvement initiatives and report progress to site and business leaders, with emphasis on compliance, throughput, yield, batch release, and service-level outcomes.
• Support inspection readiness by improving process discipline, documentation practices, training effectiveness, and adherence to standard operating procedures.
• Lead the Operational Excellence team through regular goal setting, performance reviews, coaching, workload balancing, and professional development to build sustainable site capability in Lean, Six Sigma, and structured problem solving.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Strong knowledge of current Good Manufacturing Practices (cGMP), FDA expectations, and applicable international regulations for pharmaceutical manufacturing.
• Working knowledge of pharmaceutical quality systems, including deviations, CAPA, change control, document control, training, and inspection readiness.
• Experience using data collection, statistical analysis, and performance management tools to improve process capability, reduce variability, and drive fact-based decisions.
• Experience operating in a Lean culture within a regulated manufacturing environment.
• Ability to work effectively in a team-based culture and collaborate successfully with employees at all organizational levels and across multiple functions.
• Excellent planning skills, including resource allocation, timeline development, and prioritization of multiple improvement initiatives.
• Detail oriented with the ability to analyze information, establish metrics, and clearly connect improvement priorities to business, compliance, and patient-impact objectives.
• Strong understanding of data integrity, documentation discipline, and the need to maintain validated processes and controlled changes in pharmaceutical operations.
• Excellent interpersonal, communication, problem-solving, and organizational skills.
• Ability to influence others, build alignment, and gain acceptance on issues of significant importance in a highly regulated environment.
• Ability to motivate, influence, and lead others with and/or without direct supervisory authority.

Core Values

The Manager Operational Excellence 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. We are committed to treating 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.
• 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 collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• 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.

Education & Experience

• Bachelor’s degree, preferably in a scientific or engineering discipline, or equivalent education/experience.
• A minimum of eight years of experience leading transformation or continuous improvement initiatives in manufacturing, with at least 3 years in a leadership role; experience in pharmaceutical, biotech, medical device, or other highly regulated operations preferred – other industry experience will be considered in combination with strong continuous improvement background.
• Demonstrated capability in applying systematic analytical methods and continuous improvement tools such as Six Sigma (DMAIC), Value Stream Mapping, Control Plans, Mistake Proofing, Root Cause Analysis, Corrective and Preventive Action, Kaizen, and 5S.
• Previous supervisory/leadership experience required, including direct management of Operational Excellence, continuous improvement, or other cross-functional technical teams.
• Strong understanding and application of Lean and Six Sigma methodologies. Lean/Six Sigma Green Belt or Black Belt certifications strongly preferred.

Working Conditions

• This is an on-site position. A hybrid work arrangement may be available based on business needs.
• Working conditions are typical for a pharmaceutical manufacturing and office environments.

Compensation and Benefits

• Annual pay range $125,000 - $135,000
• Bonus eligible
• Relocation assistance available
• Benefits information: https://www.tolmar.com/careers/employee-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.