Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Job Description
Job Title: Director, PPI / Operational Excellence - Drug Substance Division
Location/Division Specific Information
Thermo Fisher Scientific - Drug Substance Division is a rapidly growing, dynamic contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve.
This role provides oversight to all divisional locations. The role is based in the United States. Time may be spent at all divisional facilities including up to 50% travel to network locations globally.
How will you make an impact?
The Director, PPI / Operational Excellence is a global leader of the PPI / operational function for the drug substance business. This role is key to achieving our ambitious revenue growth and productivity goals while ensuring the quality of our products and compliance of our operations.
What will you do?
Key Responsibilities:
In collaboration with executive leadership, develop an operational excellence vision and strategy supporting the Division's long-term goals.
Mentor leaders in effectively communicating and implementing this operational excellence strategy, expectations of others, and related improvement goals within their organizations.
Prioritize opportunities for process improvement, cost reduction, and operational efficiency gains through data analysis, process mapping, and benchmarking.
Apply operational excellence methodologies and techniques, such as Lean, Six Sigma, and Total Quality Management (TQM) to improve overall performance.
Develop the operational excellence capabilities of colleagues within the Division enabling them to proactively identify and successfully conduct improvements.
Develop a culture of business system leadership through the use of a variety of mentor tools and methodologies, such as important metrics leadership, tiered daily management systems, Gemba walks, and leader standard work.
Lead the Divisional PPI Steering Committee to ensure an active pipeline of continuous improvement projects aligned to business priorities, metrics, and results.
Collaborate with leaders to identify and track relevant metrics for measuring progress and taking corrective actions.
Collaborate with collaborators and support functions (e.g., IT, Quality) to identify, evaluate, and deploy technology solutions that support operational excellence initiatives.
Champion a culture of continuous improvement, innovation, and quality by engaging employees, promoting open communication, and recognizing achievements.
Stay updated on emerging trends, standard methodologies, and regulatory requirements related to operational excellence, ensuring the organization remains up to date.
Regularly report to the executive team on the progress and the impact on the organization's performance.
Experience:
10+ years of related experience leading operational excellence, process improvement, or quality management in a large, complex organization.
Black-belt Certification in Lean, Six Sigma, or other recognized methodologies.
Use Six Sigma Black Belt experience with statistical software like Minitab and/or R, and new technologies like AI models, to analyze technical data for improvements.
Experience leading kaizen events including elements such as standard work, process design, SIPOC, strategy deployment, A3 Thinking, value-analysis/value engineering, error-proofing, material flow, Heijunka, and kanban.
Consistent track record in moving strategy into action and delivering measurable business results through the implementation of operational excellence initiatives.
Strong analytical, problem-solving, and data-driven decision-making skills.
Excellent communication, facilitation, and social skills, with the ability to build positive relationships and influence collaborators at all levels.
Demonstrated experience in organisational change and leading cross-functional teams.
Proficient in using data analysis and visualization tools (e.g., Tableau, Power BI).
Experience in deploying technology solutions to support operational excellence initiatives is a plus.
Familiarity with industry-specific regulations and standard methodologies for operational excellence.
Understanding of applicable regulatory requirements and industry mentorship (esp. FDA, EMA, ICH, ISPE). Audit experienced is preferred.
