Director of Global Quality Sterility Assurance

Merz North America - Racine, WI

Full-time - Senior

Racine, WI

Wholesale Trade Agents and Brokers

About the position

The Director of Global Quality Sterility Assurance is responsible for establishing and overseeing global sterility assurance and contamination control governance programs. This role involves driving the harmonization and optimization of microbiological processes across multiple sites, ensuring compliance with regulatory standards, and providing technical leadership in microbiological laboratory methods. The position requires engagement with senior leadership and external stakeholders, as well as proactive surveillance of regulatory requirements and implementation of process improvements.

Responsibilities

• Establish global sterility assurance and contamination control governance programs including policies, standards, and procedures.
• Drive harmonization and optimization of multi-site microbiological processes for Merz products.
• Provide global oversight regarding validation of microbiological laboratory methods.
• Represent Merz's technical position during regulatory and third-party inspections.
• Develop and mentor technical staff for future sterility assurance leadership.
• Lead implementation of automation and novel technologies in microbiological processes.
• Conduct complex investigations regarding microbiological deviations in manufacturing and laboratories.
• Support product and process risk management processes.
• Establish a global system for routine review of sterility assurance system data.
• Manage departmental budgets in accordance with approved targets.

Requirements

• Bachelor's Degree in Microbiology or related physical science required.
• Master's degree in Microbiology or related physical science or Business preferred.
• Minimum of 10 years of experience in the Medical Products industry (Medical Device, Biotechnology, Pharmaceutical) required.
• Minimum of 7 years in a cGMP organization focusing on Microbiology and Sterile Product Manufacturing required.
• Excellent written and oral communication skills with attention to detail required.
• Strong organizational skills with the ability to prioritize tasks and adhere to timelines required.
• Highly computer literate, including proficiency in Word, Excel, and PowerPoint required.
• Fluent in English; additional language proficiencies are an asset required.
• Experience as a Microbiological Subject Matter Expert (SME) during inspections required.
• Expertise in clean facility design, qualification, and control required.
• Thorough understanding of applicable regulations (ISO 13485, ISO 14971, 21CFR Part 820, etc.) required.
• Experience in data analysis and statistical evaluation of microbiological data required.
• Competency in multiple industrial terminal sterilization methods required.

Nice-to-haves

• Experience with conducting technical/risk assessments of in-house and contract sterilization processes preferred.
• Experience in sterility assurance validation and environmental controls for pharmaceutical manufacturing facilities preferred.

Benefits

• PTO starts on the date of hire with no waiting period.
• Equal Opportunity Employer for protected veterans and individuals with disabilities.