The Senior Quality Associate ensures operations across GPS laboratories are conducted in compliance with GLP, GCLP (ISO/IEC 17025) and GRLP. It also ensures biosecurity and biosafety oversight to CSL operations are performed in accordance with relevant global, regional, and country-specific regulations and CSL internal policies and procedures.
This role supports the implementation and continuous improvement of GLP/GCLP aligned quality initiatives, systems, and processes across defined GPS laboratory sites, while advancing globally harmonized, phaseappropriate quality strategies that support GPS activities.
The position plays a key role in inspection readiness activities, audits, and driving the timely and compliant closure of quality actions, including corrective and preventive actions (CAPAs).
This role models the CSL Way and promotes a strong quality culture aligned with organizational vision and values to bring durable improvements in quality systems and processes.
Your Tasks & Responsibilities
Work with R&D partners and stakeholders to establish procedures, standards and systems according to local and regulatory standards including liaising with R&D departments regarding quality assurance and compliance related issues
Ensure compliance with documentation relevant to GLP and ISO 17025 compliance is maintained
Review and approve final study plans/protocols and study reports for compliance with the OECD Principles of GLP; manage QA statements for GLP studies to be included in final study reports
Plan and conduct GLP process inspections, facility inspections, study inspections and document inspections to determine if all studies are conducted in compliance with the OECD Principles of GLP; report inspections findings and improvement recommendations to relevant departments in efforts to maintain regulatory compliance and continuous improvement
Ensure all inspection findings are reported to Test/Site Facility Management and Study Director and Principal Investigator as applicable to relevant departments
Provide biosecurity and biosafety regulatory compliance advice and guidance to CSL facility owners and project managers
Assure inspection readiness; host/participate in external agency inspections of defined CSL facilities and lab spaces and provide support, direction and guidance relating to responses
With audit functions, support development and maintenance of internal audit program development for facilities and perform inspections as required per relevant guidelines
Ensure CSL facilities meet and maintain regulatory compliance with all local, regional, and country specific requirements for biosafety, biosecurity of facilities and products
Communicate where required appropriate with agencies to ensure facilities, licenses, documents, and databases are correct, current and in line with regulatory guidelines ensuring data, regulator correspondence, and other records are stored in CSL approved repositories as needed
Support new applications (facilities, dealings & permits) including data and document audits, review, and approval of associated documentation
Manage and maintain internal CSL databases for regulatory agencies as appropriate across relevant R&D groups globally, as required
Where required support CSL IBC Chair and Secretary for activities/enquiries related to the IBC and Department of Agriculture Steering Committee, function as a delegate for IBC Secretary as appropriate
Support OGTR, Department of Agriculture, and other relevant working groups
Support applications for import permits and approved arrangement accreditations
Your Skills and Experience
Education
BS degree in relevant biological science, science, or related discipline
Experience
Minimum 3 years’ experience working in at least one of the following: OGTR, Department of Agriculture, applicable EU Directives, and/or similarly governed laboratories
R&D Quality Assurance or relevant process development facilities
Understanding and application of standards for microbiology and pathogen safety and containment
Knowledge of OECD Principles of GLP
Experience and knowledge in the application of Quality Systems
Competencies
Commitment to improvement
Strong planning and organizational skills
Good presentation, negotiation, and decision-making skills
Strong customer focus
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
