Senior Quality Associate - Preclinical & Laboratory Quality

Please note we have two openings for this role.

Preclinical laboratory QA Staff (Advisor) ensures compliance to GLP, GCLP (ISO/IEC 17025), GRLP and other GxP requirements (as applicable). This role will support the implementation of GLP/GCLP quality initiatives, systems, and processes across the relevant R&D Preclinical and clinical lab functions at defined sites, while advancing globally harmonized phase-appropriate quality strategies for research, pre-clinical, and clinical stages of product development.


Role will support maintenance of robust quality systems, lead inspection readiness activities, manage regulatory inspections, and follow up on quality actions including corrective and preventive actions (CAPA) to ensure timely and compliant resolution of findings.


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.

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 ISO 17025 inspections as well as general 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.
• Review clinical and pre-clinical assay method development documentation.
• Review equipment validation documentation.
• Support relevant departments during GLP/GCLP regulatory inspections.
• Support regulatory compliance with OECD Principles of Good Laboratory Practice (GLP) and ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.
• Manage, facilitate and risk assess R&D deviations and change controls for implementation.
• Liaise with R&D departments and other key stakeholders regarding quality related issues with deviations, change controls and audits.
• Provide QA and compliance support for new applications and information requests associated with facilities & permits for regional regulators Dept of Agriculture.
• Support key performance metrics reporting (as needed).

Qualifications and Experience

Education

• BS Degree in relevant biological science, science, or related discipline.

Experience

• Minimum 3 years' experience in at least one of: working in laboratories under GLP/GxP conditions, Quality Assurance or relevant process development facilities.
• Experience in one of the following: R&D Quality (GMP or GLP) and/or product development teamwork.

Skills and Competencies

• Knowledge of OECD Principles of GLP.
• Knowledge of ISO/IEC 17025 - Testing and Calibration Laboratory Requirements.
• Experience and knowledge in the application of Quality Systems.
• Commitment to improvement.
• Strong planning and organizational skills.
• Good presentation, negotiation, and decision-making skills.
• Strong customer focus.

The expected base salary range for this position at hiring is $94,000 - $111,000. Please note this salary range reflects what CSL expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit and CSL Plasma at

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