Associate Director of Operational Excellence

Job Overview:

The Associate Director of Operational Excellence will lead and oversee all aspects of operational excellence programs and initiatives. This role is responsible for developing and implementing strategies to improve efficiency, quality, and productivity across all departments and locations. It is imperative that the Associate Director demonstrates the ability to work in a matrixed environment to be successful.

Responsibilities:

• Serve as a strategic partner to the COO and other members of the executive team, providing data-driven insights and recommendations to inform decision making.
• Develop and implement operational plans that align with the overall strategy.
• Lead process improvement initiatives across the organization, using Lean Six Sigma methodology.
• Conduct root cause analysis to identify opportunities for process improvements.
• Design and oversee implementation of new processes and procedures.
• Train and coach employees on new processes and procedures
• Monitor compliance with new processes and procedures.
• Evaluate the effectiveness of new processes and procedures.
• Identify and implement technology solutions to improve efficiency and productivity.
• Manage operational budget and negotiates contracts with vendors.
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in business administration, engineering, or related discipline, Master’s degree in business administration, engineering, or related discipline, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Certification in Six Sigma or other process improvement methodology.
• Experience working in a lean manufacturing environment.
• Proven track record of success in operational excellence, leading and executing process improvement initiatives.
• Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrated knowledge of learning management software, or equivalent, required.
• Demonstrated knowledge of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Demonstrated Working knowledge of industry guidelines including cGMP, regulatory guidelines (i.e.: FDA, EU, ICH, ISO).
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrates the ability to be highly collaborative, working well in teams and keeps their chain of command and team well-informed of important business matters.
• The ability to build and maintain strong interpersonal relationships, gaining trust and confidence from all levels within and external to the organization.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately, according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Driven and highly motivated with and strong work ethic; solutions-oriented, a self-starter and strategic thinker who has strong attention to detail and is accustomed to working in a deadline-focused, high-pressure environment.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.

Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary