The Steely Group
The Director of Operations will provide the leadership and management necessary to ensure that the San Jose, CA facility has the proper direction to achieve all operational objectives (safety, quality, service, financial, organizational development, etc.) while providing exceptional customer experience. Objectives are achieved by collaborating both within Operations and cross functionally. This includes ensuring proper budgets, controls, procedures, project management, and systems are in place to effectively deliver preparations to customers, while ensuring safety, quality, regulatory compliance, and achieving operating efficiencies. The position is responsible for leading site activities including, but not limited to, compounding, packaging, receiving/shipping, warehousing, inventory control, and facilities management. Additionally, this role is accountable to assure a culture of continuous improvement within Operations through employee engagement, education, support, and transformational change management processes.
Responsibilities
Define and execute short- and long-range operational strategies aligned with corporate goals.
Lead cross-functional collaboration within and beyond Operations to drive performance and innovation.
Champion a culture of accountability, teamwork, and operational excellence.
Ensure a safe working environment and promote a zero-injury culture.
Maintain strict compliance with all applicable regulations (FDA, USP, DEA, OSHA, cGMP).
Ensure compounded products meet all quality standards and SOPs with minimal waste.
Oversee day-to-day manufacturing activities across multiple shifts and product lines.
Collaborate with planning and scheduling teams to ensure efficient and timely production.
Develop and monitor KPIs to continuously improve safety, quality, delivery, and cost metrics.
Manage labor and equipment resources to meet production goals.
Lead employee development through training, mentoring, and succession planning.
Foster a culture of continuous learning and professional growth.
Ensure facilities and equipment are maintained to support uninterrupted operations.
Lead initiatives related to equipment upgrades, automation, and facility improvements.
Implement best practices in facility and equipment design to drive efficiency.
Drive process improvements using Lean, Six Sigma, and other operational excellence tools.
Lead resolution and corrective actions for atypical or unplanned manufacturing events.
Champion change management initiatives and adoption of new technologies.
Develop and manage departmental budgets in line with business goals.
Identify cost-saving opportunities without compromising quality or compliance.
Requirements / Qualifications
Successfully driven safety, quality, and operational performance improvements in an FDA-regulated production environment (pharmacy experience a plus).
Led teams and operations for 5+ years within a regulated setting, ensuring compliance with USP, FDA, OSHA, and DEA standards.
Applied proven systemic project management tools and continuous improvement methods to deliver measurable business results.
Conducted root cause analyses and developed multi-optioned, cost/benefit-supported solutions for complex operational challenges.
Led Lean, Six Sigma, or automation initiatives that resulted in improved efficiency and performance.
Earned a relevant Bachelors or Masters degree in a field aligned with operations, manufacturing, or life sciences.
A proven leader with strong people management, change leadership, and cross-functional collaboration skills.
Highly organized and able to operate, manage, and prioritize effectively in a fast-paced, multi-tasked environment.
Skilled in analyzing dynamic business scenarios across safety, compliance, automation, equipment, process, and people dimensions to identify root causes and drive data-driven solutions.
An excellent communicator who leads by example and motivates others toward shared goals.
Knowledgeable in Standard Work Principles and able to implement visual factory practices to drive Operational Excellence.
Proficient in project management and continuous improvement methodologies such as Lean and Six Sigma.
Tech-savvy, with strong computer skills including Microsoft Office and experience using regulated business applications (ERP, CMMS, QMS, etc.).
The Steely Group
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Responsibilities
Define and execute short- and long-range operational strategies aligned with corporate goals.
Lead cross-functional collaboration within and beyond Operations to drive performance and innovation.
Champion a culture of accountability, teamwork, and operational excellence.
Ensure a safe working environment and promote a zero-injury culture.
Maintain strict compliance with all applicable regulations (FDA, USP, DEA, OSHA, cGMP).
Ensure compounded products meet all quality standards and SOPs with minimal waste.
Oversee day-to-day manufacturing activities across multiple shifts and product lines.
Collaborate with planning and scheduling teams to ensure efficient and timely production.
Develop and monitor KPIs to continuously improve safety, quality, delivery, and cost metrics.
Manage labor and equipment resources to meet production goals.
Lead employee development through training, mentoring, and succession planning.
Foster a culture of continuous learning and professional growth.
Ensure facilities and equipment are maintained to support uninterrupted operations.
Lead initiatives related to equipment upgrades, automation, and facility improvements.
Implement best practices in facility and equipment design to drive efficiency.
Drive process improvements using Lean, Six Sigma, and other operational excellence tools.
Lead resolution and corrective actions for atypical or unplanned manufacturing events.
Champion change management initiatives and adoption of new technologies.
Develop and manage departmental budgets in line with business goals.
Identify cost-saving opportunities without compromising quality or compliance.
Requirements / Qualifications
Successfully driven safety, quality, and operational performance improvements in an FDA-regulated production environment (pharmacy experience a plus).
Led teams and operations for 5+ years within a regulated setting, ensuring compliance with USP, FDA, OSHA, and DEA standards.
Applied proven systemic project management tools and continuous improvement methods to deliver measurable business results.
Conducted root cause analyses and developed multi-optioned, cost/benefit-supported solutions for complex operational challenges.
Led Lean, Six Sigma, or automation initiatives that resulted in improved efficiency and performance.
Earned a relevant Bachelors or Masters degree in a field aligned with operations, manufacturing, or life sciences.
A proven leader with strong people management, change leadership, and cross-functional collaboration skills.
Highly organized and able to operate, manage, and prioritize effectively in a fast-paced, multi-tasked environment.
Skilled in analyzing dynamic business scenarios across safety, compliance, automation, equipment, process, and people dimensions to identify root causes and drive data-driven solutions.
An excellent communicator who leads by example and motivates others toward shared goals.
Knowledgeable in Standard Work Principles and able to implement visual factory practices to drive Operational Excellence.
Proficient in project management and continuous improvement methodologies such as Lean and Six Sigma.
Tech-savvy, with strong computer skills including Microsoft Office and experience using regulated business applications (ERP, CMMS, QMS, etc.).
The Steely Group
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