The Opportunity

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