Sterility Assurance Manager

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

Join our collaborative Quality team at Thermo Fisher Scientific as a Senior QA Sterility Assurance SME, where you will serve as the site champion and subject matter expert for Sterility Assurance.

Operating within a multi-product, multi-client biopharmaceutical site supporting both clinical and commercial manufacturing, you will provide leadership and expertise in aseptic practices, contamination control, environmental monitoring, sterilization, and the prevention of product and cross-contamination.

As the primary point of contact for Sterility Assurance, you will define and maintain processes supporting product sterility and contamination prevention and will have decision-making authority within your area of expertise. You will partner closely with Manufacturing, Quality Control, Engineering and other site functions to continuously strengthen the site's aseptic standards and Sterility Assurance culture.

Your expertise will directly support the safe and compliant manufacture of high-value biopharmaceutical products and help ensure continued alignment with applicable GMP regulations, international regulatory expectations and Thermo Fisher Scientific quality standards.

KEY RESPONSIBILITIES:

• Act as the site's Sterility Assurance Lead and subject matter expert, providing technical leadership and decision-making within the Sterility Assurance field

• Develop strategies to strengthen the site's Sterility Assurance culture and continuously improve aseptic manufacturing standards

• Escalate major and critical Sterility Assurance events to the Site Quality Head, together with appropriate assessments, decisions and remediation plans

• Develop, maintain and oversee the site's Contamination Control Strategy (CCS) and other key documents related to sterility assurance, environmental contamination and cross-contamination prevention

• Develop, maintain and lead execution of the site's Aseptic Improvement Plan, in partnership with Manufacturing and other site departments

• Review and approve aseptic process simulation strategies, ensuring they appropriately demonstrate the effectiveness and robustness of aseptic manufacturing processes

• Author environmental qualification protocols and reports for classified production areas, including Performance Qualification Environmental Monitoring (PQEM) activities

• Define environmental monitoring locations and frequencies for classified manufacturing areas and utilities using a science- and risk-based approach

• Conduct frequent shop-floor inspections and audits to assess compliance with Sterility Assurance and aseptic processing requirements

• Lead the preparation and close-out of Sterility Assurance-related audits and communicate observations and improvement opportunities to Manufacturing and relevant support functions

• Ensure sterilization and filtration processes are performed in accordance with applicable requirements and approved strategies

• Actively participate in customer and regulatory audits and inspections, representing the site on topics within the Sterility Assurance area of expertise

• Provide expert support to major and critical investigations involving product contamination, environmental monitoring excursions or events with a potential impact on product sterility

• Review and approve periodic environmental monitoring reports in collaboration with Quality Control and Operations

• Participate in defining strategies for technical interventions within classified areas, including appropriate protection of the manufacturing environment, and act as final approver for the execution of these interventions

• Participate as an active member of the intersite Sterility Assurance Lead community, sharing best practices from across the network and communicating site challenges and improvement opportunities

• Develop and deliver training on key Sterility Assurance topics, including gowning, cleaning, material transfer, environmental monitoring, aseptic process simulations and aseptic practices

• Maintain current knowledge of applicable procedures, regulatory requirements, internal standards and industry expectations related to Sterility Assurance

• Promote open, effective, constructive and collaborative communication across functions and levels of the organization

• Ensure activities are performed in accordance with applicable quality and safety requirements, including appropriate use of personal protective equipment

• Support additional activities within the area of expertise as required by site leadership

REQUIREMENTS:

• Master's Degree or equivalent university education in Biology, Biochemistry, Chemistry or a related scientific discipline

• Minimum of 10 years of relevant experience within the pharmaceutical industry

• Minimum 3 years of experience in a pharmaceutical manufacturing environment (QA culture), preferably within aseptic manufacturing

• Strong expertise in Sterility Assurance, aseptic processing and contamination control principles

• Expert ability to read, interpret and apply internal quality standards, GMP requirements and regulatory expectations

• Strong understanding of contamination control strategies and the principles governing the prevention of microbiological, environmental and cross-contamination risks

• Experience with environmental monitoring strategies, classified area qualification and risk-based determination of monitoring locations and frequencies

• Experience with aseptic process simulations and the principles governing their design, execution and assessment

• Knowledge of sterilization and filtration processes used within pharmaceutical manufacturing

• Experience supporting or leading investigations involving contamination, environmental monitoring excursions or potential product sterility impact

• Experience supporting customer audits and regulatory inspections and presenting technical topics within an area of expertise

• Strong technical writing skills, with the ability to author and review strategies, protocols, reports and other GMP documentation

• Demonstrated ability to coach, train and explain complex technical and scientific concepts to diverse audiences

• Strong cross-functional collaboration, communication and influencing skills

• Ability to provide independent technical judgment and make decisions within the Sterility Assurance area of expertise

• Fluency in French and English, both written and spoken are a must