Sterilization – Site Leader

Sterilization Site Leader
Reports To: Senior Director, Sterilization Services

Position Summary
The Sterilization Plant Leader is responsible for the safe and efficient operation of the sterilization facility. This role involves sourcing, recruiting, and overseeing a team of employees while ensuring all safety and regulatory standards are met. The leader manages all supply through the plant—from validation and test runs to full production—and oversees schedules to ensure a safe, effective ramp-up and resilient day-to-day operations. You will collaborate with cross-functional teams to foster a culture of Safety, Quality, and continuous business growth.

Essential Duties & Responsibilities
Team Leadership
Build the Team: Source, hire, and create a team of sterilization professionals, supervisors, operators, and technical support.

Development: Manage, mentor, and develop teams to ensure the culture aligns with the mission and values of the organization.

Performance Management: Create and manage guidance, training, and performance criteria aligned with corporate goals.

Culture: Foster a environment of safety, quality, and accountability from start-up through full operations.

Safety and Environmental Compliance
Zero Incident Culture: Ensure all plant equipment and buildings follow safety regulations to maintain a zero-incident environment.

Standard Operating Procedures: Oversee and execute processes to ensure employee safety remains the top priority.

EHS Collaboration: Work with the EHS organization to create continuous safety monitoring programs.

Environmental Stewardship: Adhere to all environmental regulations during construction, commissioning, and validation.

Emergency Protocols: Develop and implement protocols for sterilization-related emergencies or equipment failures.

Sterilization Operations and Supply
Validation & Qualification: Lead all pre-operations activities to ensure the plant is operational and aligned with business strategy.

QMS & Audits: Support the site Quality Management System (QMS) and act as the lead for all internal and external audits.

Process Improvement: Implement sterilization procedures that support the reduction of Ethylene Oxide (ETO) usage.

P&L Management: Own the site’s Profit & Loss (P&L) statement and ensure financial practices align with best practices.

Metrics: Collaborate to create operational metrics that align with the site’s overall business plan.

Education & Special Trainings
Education: Bachelor’s degree in Microbiology, Sterilization, or a related field (MBA or Master’s preferred).

Experience: 10+ years as a professional in Sterilization, Manufacturing, Quality, or Business.

Leadership: 8+ years of successful leadership experience, preferably in the Medical Device sector.

Expertise: Proven experience in strategic planning, process standardization, and implementing transformational changes in complex, matrix organizations.

Qualifications & Experience
Behavioral Competencies
Innovation: Enthusiastic about establishing new approaches; never content with the status quo.

Decision Making: Distinctive leadership with the ability to make tough, well-respected decisions.

Resilience: Demonstrated ability to lead and motivate teams through change, ambiguity, and high-pressure environments.

Relationship Building: Strong interpersonal skills with the ability to build trust at executive levels.

Technical Skills
Strategic Vision: Ability to create actionable short, mid, and long-term strategies.

Subject Matter Expert: Deep knowledge of Sterilization regulations and end-to-end (E2E) supply chain.

Project Management: Experience in project management is required (certification preferred).