AddressThe Opportunity: Reporting to Head of Enterprise Sterility Assurance, the Sterility Assurance Regional Lead will be responsible for the leadership, oversight and life cycle management for the contamination control governance elements including Sterility Assurance concept pillars, validation controls and monitoring controls at the region based CSL manufacturing and routine partners CMOs sites. The scope is applying to both sterile steps as we bioburden-controlled steps of the manufacturing processes. • You develop a Sterility Assurance Enterprise culture consistently at all sites under your leadership. • You set objectives and provide clear direction for execution with the Sterility Assurance teams at all respective sites in the region • You provide strategic leadership to the sites related to Sterility Assurance GSOPs, culture and continuous improvement • You partner with Sterility Assurance Enterprise Heads of Sterility Assurance Systems & Standards and CMOs Strategy to develop and own the CSL Sterility Assurance systems and processes in both dimensions of monitoring and validation of the Enterprise core Sterility Assurance activities, perform global regulatory intelligence for changes/updates and perform external advocacy and benchmark (shared accountability) • You partner with Sterility Assurance Enterprise Heads of Sterility Assurance Systems & Standards and CMOs Strategy and sites leadership teams to develop strategies to ensure continuous adherence to regulatory and CSL standards related to Sterility assurance governance and drive improvements and to ensure standards are executed and maintained across the manufacturing sites. • You specifically maintain the Annex1 gaps mitigation and CAPEX driven remediation • You implement and drive a standardized Sterility Assurance Enterprise learning culture and ensure the knowledge management across the regional sites • You are responsible for routine Sterility Assurance oversight of CMOs for the region (if applicable) including accountability in the oversight of Sterility Assurance deviations, improvement plans, audits and any routine business activities to better support of CSL functions partnering with the CMOs such as ESQ and ESI • The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization. Responsibilities: • Provide leadership and guidance to several local teams of Sterility Assurance professionals at the CSL global manufacturing sites • Provide strategic leadership to the site operations and quality functions related to sterility assurance • Individual Performance Management: Develop, agree and evaluate the divisional objectives as well as objectives for direct reports • Together with Head of Enterprise Sterility Assurance, sites heads and sites Quality heads, develop and agree site objectives related to sterility assurance • Provide input for organizational design and staffing decisions. Plan and supervise optimal use of resources (staff, material, equipment and rooms) to ensure efficient and effective achievement of objectives • Build and sustain employee engagement through clear direction for execution, development of staff through training, further education, delegation of duties and continuous improvement • Encourage and facilitate team spirit and motivation of staff by means of an open feedback culture and recognition of achievements • Generate and actively manage further education planning and position descriptions of direct reports • Oversee the ongoing education and development of employees within the department • Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve. • Work collaboratively with the Global Enterprise SA team to provide a holistic contamination control strategy and improvement plans at the CSL Manufacturing sites and CMOs. • Ensure appropriate development, implementation and maintenance of sterility assurance GSPOs and processes consistent with global governance, regulatory requirements and industry standards (quality systems, policies, procedures and work instructions). • Collaborate with internal and external partners for the design of best practice sterility assurance controls for the contamination control strategy and life cycle management - to deliver on time and to the required standards and regulatory requirements with respect to validation activities affecting sterile manufacturing (Fill / Finish area incl. filling, lyophilizers, sterilizers, isolator technology and auxiliary equipment, personnel training and qualification, cleaning and disinfection programmes etc). • Use knowledge of the facility, process and equipment to design the validation controls on an aseptic facility applicable to the core Sterility Assurance activities (i.e. aseptic media fill simulation program) • Use knowledge of the facility, process and equipment to design the microbiological controls of the aseptic facility including the environmental monitoring program, in process monitoring and finished product monitoring, including the promotion of new methods and new technology (Rapid microbiology methods). • Establishment and maintenance of quality on the floor processes for critical cleanliness and aseptic behavior • Provide expert input to deviation investigation in the areas of sterility Assurance failures (filtration, aseptic filling and lyophilization and sterility, media fill and bioburden test fail) • Support to local and global capacity expansion/new projects to ensure reliable supply for our patients • Support regulatory document submissions, internal and external (pre-approval and routine) GMP inspections as SME. • Responsibility for the site's inspection readiness and in responding to inspection observations relating to sterility assurance. • Responsible for the generation of the documentation (IQ/OQ/PQ documents, SOPs, risk assessments, etc in the areas relating to sterility assurance, ensure compliance to GMP and that required standards are met. Education: • Degree in Microbiology/biology life sciences. Experience • Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, to include design, validation and monitoring, life cycle management and cGMP compliance. • +8 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing • Extensive professional experience in leading teams with respect to aseptic cleanrooms, process, equipment, consumables and utilities, validation and microbiological monitoring • Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines. • Experience in the manufacturing of biologics • Direct experience executing Quality Assurance function and system within a manufacturing and QC Microbiology/Sterility Assurance context. • Experience in interacting with regulatory authorities including submissions and inspections. • Knowledge of auditing practices and procedures
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
