Site Leader, Sterility Assurance

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Reporting into the Global Director Sterility Assurance, the Quality Sterility Assurance 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 CSL Behring site.

• Provide strategic leadership to the site related to Sterility Assurance standards, culture and continuous improvement
• Partner closely with the global function leads as well as site leadership team, develop strategies to ensure continuous adherence to regulatory and CSL standards related to Sterility assurance governance and drive improvements

• Provide QA oversight of quality standards and systems aligned with the Sterility Assurance function in the above areas for the site
• Set objectives and provide clear direction for execution within area of responsibility
• Implement and drive a learning culture and ensure a vertical and horizontal knowledge management
• Partner closely with his or her peers in Global and Local Quality Sterility Assurance from the other manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all areas the appearance and reporting of the documentation in the stated areas is standardized.
• The position requires the ability to build and maintain strong relationships and collaborate effectively with all levels and cross functionally within the organization.

Safety:

• Responsibility for the safety of your employees and the technical workplace safety including instruction, training, establishment of operating procedures and continuous education in your area. You assure that all safety guidelines and rules are strictly followed at all times.
• Play a proactive role in the investigation of accidents and near misses as well as in the implementation of corrective actions and you are supported by the safety responsible person of your area. You assure that your team are able to fulfill their tasks.
• Contribute to the improvement of safety and the safety culture as a role model and you assure that the agreed safety objectives are appropriately cascaded into the workplans of your employees and you commit to achieving those objectives
• Encourage your employees to take an active part in the continuous improvement of our safety and safety culture.

Leadership:

• Live CSL Values and implement CSL Guidelines
• Provide leadership and guidance to a local team of Sterility Assurance Quality professionals at the CSL Behring 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 Global head SA director, site head and site Q head, 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.
• Generate and achieve divisional budget

Technical Duties:

• Work collaboratively with the Global SA team to provide a holistic microbial contamination control strategy and improvement plan at the CSL Behring Manufacturing site.
• Ensure appropriate development, implementation and maintenance of sterility assurance standards 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 microbial 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 including, aseptic media fill simulation programme (including risk assessment of interventions), container closure integrity, filter bacterial retention, packaging integrity, validation and re-validation of the HVAC and HEPA system, smoke studies, etc.
• Use knowledge of the facility, process and equipment to design the microbiological controls of the aseptic facility including the environmental monitoring programme, in-process monitoring and finished product monitoring, including the use 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 area of sterile 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 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. Ensure a harmonized appearance of all documentation across the global network.
• Ensure that global standards are met for best practice

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

Competenies:

• Strong leadership skills (influencing, negotiating, priority setting, timely decision making) in addition to leading staff by example, providing technical and personal support
• Demonstrated ability for conceptual and analytical thinking from a holistic system wide to detail view, with good judgement to reconcile ambiguities
• Ability to influence and motivate others at all organizational levels through clear, concise and impactful verbal and written communication skills while maintaining a cohesive team environment.
• Ability to work collaboratively and pragmatically with others to ensure successful outcomes
• The ability to aseptically gown and enter aseptic filling cleanrooms is essential
• In depth knowledge and experience of performing risk-based assessments and root cause investigations
• In-depth knowledge of cGMP’s, FDA, TGA, EU and other relevant GxP regulations including current knowledge of industry best practice with respect to sterility assurance principals
• Excellent verbal and written communication skills with the ability to effectively present within all levels of the organization, with external colleagues and collaborators and regulatory agencies
• Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks.
• Excellent skills in critical review of documents, protocols, reports and SOPs.
• Develop, Contribute and support local and global strategic plans