Director, Operational Excellence

Job Description

Job Description

August Bioservices is seeking a highly organized, systems-oriented, and execution-focused leader to establish and lead the company’s continuous improvement program. This role will be responsible for identifying opportunities to progress both efficiency and compliance, ensuring cross-functional coordination, operational readiness, schedule adherence, and the execution discipline required to support a rapidly scaling sterile injectable manufacturing organization. 

This leader will serve as the central integrator across Manufacturing, Quality, Supply Chain, Warehouse, Planning, Training, Technical Operations, and Maintenance to ensure activities required to execute manufacturing operations are proactively coordinated, visible, and completed on time. 

This role will also oversee continuous improvement initiatives, such as 5S, Kaizen, Gemba, Lean Manufacturing, and Six Sigma. 

This role will establish the operational management cadence, readiness governance, escalation processes, and performance visibility necessary to drive reliable execution and scalable operational performance across the organization. 

This role is not responsible for directly managing manufacturing personnel. Instead, the role is accountable for driving continuous improvement, organizational readiness, execution coordination, dependency management, and operational accountability across functions. This position will report directly to the COO and will work closely with executive leadership across the organization. 

Responsibilities

Continuous Improvement and Executional Readiness Leadership 

• Establish and lead the company’s continuous improvement program and lead cross-functional continuous improvement initiatives

• Develop and implement structured readiness reviews to ensure all prerequisites for successful execution are completed prior to the start of planned activity 

• Coordinate cross-functional activities required to support execution, including staffing, training, materials, documentation, equipment readiness, and quality support 

• Drive alignment between scheduling, staffing, material availability, and operational capabilities 

• Identify execution risks proactively and drive mitigation planning before operational impact occurs 

• Establish escalation mechanisms for readiness gaps, schedule risks, and execution barriers 

Schedule Adherence & Dependency Management 

• Partner closely with Planning and Manufacturing leadership to improve schedule attainment and execution reliability 

• Ensure critical dependencies are identified, tracked, and completed on time 

• Implement structured tracking of execution delays, schedule misses, and recurring operational constraints 

• Lead recovery planning efforts when schedule disruptions occur 

• Drive accountability for execution commitments across functions 

• Design and implement standardized operational management cadences including but not limited to: daily execution review meetings, readiness review meetings, deliverable reconciliation processes, escalation reviews, recovery planning sessions. 

• Implement mechanisms for visibility into incomplete work, execution bottlenecks, and resource constraints 

Documentation & Investigation Performance 

• Partner with Quality and Manufacturing leadership to improve documentation completion timelines and investigation responsiveness 

• Implement performance tracking for: documentation completion cycle times, investigation aging, review timelines, recurring documentation errors, drive visibility and accountability around execution-impacting quality activities 

Performance Visibility & Metrics 

• Develop operational dashboards and management reporting focused on: Schedule adherence, readiness status, execution delays, staffing coverage, documentation timeliness, investigation performance, productivity metrics, bottleneck analysis 

• Establish objective operational visibility and escalation mechanisms for leadership review 

• Utilize data and trend analysis to identify recurring execution risks and improvement opportunities 

Organizational Leadership 

• Serve as a cross-functional leader capable of influencing without direct authority 

• Build strong working relationships across all operational and support functions 

• Drive a culture of accountability, proactive communication, operational discipline, and execution ownership 

• Support organizational scaling efforts through implementation of structured operational systems and management practices 

• Maintain a visible presence within operational areas to understand challenges and drive alignment 

Qualifications

Required Experience 

• Bachelor’s degree in Engineering, Operations, Supply Chain, Basic Sciences, Business, or related field 

• 8+ years of experience in complex operational environments with increased leadership responsibility 

• Demonstrated success leading cross-functional execution, coordination, and operational readiness initiatives through continuous improvement principles 

• Experience operating within highly regulated manufacturing environments 

• Strong experience implementing operational management systems, execution cadence, and accountability frameworks 

• Proven ability to manage complex dependencies and competing priorities across multiple functions 

• Experience utilizing metrics and operational data to drive performance improvements 

Preferred Experience 

• Experience within sterile injectable pharmaceutical manufacturing, biologics, medical device, or other highly regulated industries 

• Experience in CDMO or high-complexity manufacturing environments 

• Experience supporting rapid organizational scaling and operational maturity initiatives 

• Familiarity with GMP documentation systems, training systems, deviation management, and manufacturing scheduling processes 

• Continuous Improvement training and experience

Leadership Attributes: 

• Exceptional organizational discipline and attention to detail 

• Strong systems thinking and operational problem-solving capabilities 

• Ability to drive accountability and follow-through across functions 

• Executive presence and composure under pressure