Director, Operational Excellence

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: d aily execution review meetings, r eadiness review meetings, d eliverable reconciliation processes, e scalation reviews, r ecovery 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: d ocumentation completion cycle times, i nvestigation aging, r eview timelines, r ecurring documentation errors, d rive visibility and accountability around execution-impacting quality activities

Performance Visibility & Metrics

Develop operational dashboards and management reporting focused on: Schedule adherence, r eadiness status, e xecution delays, s taffing coverage, d ocumentation timeliness, i nvestigation performance, p roductivity metrics, b ottleneck 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

High sense of urgency balanced with sound judgment

Strong communication and escalation management skills

Comfort operating within ambiguity and rapidly changing environments

Ability to influence without relying on formal authority

Data-driven decision-making and operational rigor

Relentless focus on execution reliability and organizational alignment