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Senior Manager, Research Laboratory Compliance Specialist

CSL Behring -
Melbourne VIC

Apply Now

Job Details

Full-time
9 days ago

Qualifications

Research laboratory experience
Management
Doctoral degree
Laboratory experience
Master's degree
Analysis skills
Leadership
Communication skills

Full Job Description

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Discovery & Product Development

Job Type: Full Time

Location: Melbourne, Victoria, Australia

Employer Reference: R-285830

Job Description

The Senior Manager, Research Laboratory Compliance Specialist is responsible for ensuring Research laboratory compliance through the consistent application of CSL standards, regulatory requirements, and industry best practices across CSL Melbourne Research laboratories including the Vivarium. This role serves as the central point of accountability for laboratory compliance, providing centralised leadership, governance oversight and operational support to ensure compliance activities and effectively managed and maintained.

This role partners closely with EHS, Facilities, QA, Operations, laboratory scientific teams and management to coordinate compliance programs, manage or support regulatory inspections and audits, oversee laboratory training and documentation compliance, and ensure effective management of permits, deviations, CAPAs, change controls and, risk registers. This role requires expertise and deep understanding of regulatory laboratory guidelines and excellent communication and influencing skills to effectively collaborate with internal stakeholders in cross functional teams.

Main Responsibilities & Accountabilities

Leadership and Strategy

Provide strategic leadership and oversight for Research laboratory compliance across CSL Melbourne laboratories including the Vivarium, ensuring alignment with CSL standards, regulatory requirements and industry best practices
Develop and implement a sustainable laboratory compliance framework that supports operational excellence, audit readiness and risk reduction across Research
Establish compliance priorities, governance processes and performance measures that enable proactive management of regulatory obligations and compliance risks
Provide expert leadership and guidance on laboratory compliance for Research activities and laboratory operations including permits

Operational Excellence for Research Laboratories

Lead compliance oversight for Research laboratories, ensuring adherence to applicable regulatory, safety, quality and ethical requirements
Lead audit and inspection readiness activities including with QA and EHS and coordinate regulatory audits and inspections where applicable
Ensure audit findings, compliance actions and regulatory commitments are tracked, monitored and closed in a timely manner
Manage and monitor deviations, CAPAs, change controls, risk assessments and laboratory risk registers to ensure effective compliance oversight
Govern laboratory training curricula, documentation compliance and record management requirements
Drive proactive identification, assessment and mitigation of compliance and operational risks to strengthen regulatory compliance and audit readiness

Collaboration and Networking

Serve as the primary point of contact for laboratory compliance, fostering strong partnerships with internal CSL teams such as QA, EHS, Facilities, Operations and Research scientists and leaders
Collaborate with internal and external stakeholders to coordinate compliance activities and regulatory interactions including for inspections
Build cross-relationships to ensure an integrated approach to laboratory compliance, risk management and governance
Provide compliance guidance and support to global Research teams where applicable

Innovation and Technology

Strengthen compliance capability and awareness across Research laboratories through training, guidance and continuous improvement initiatives
Identify opportunities to streamline compliance activities through standardisation and process optimisation

Qualifications, Skills & Experience

Postgraduate degree (preferably MSc or PhD) and / or extensive experience in laboratory compliance
Minimum of 5 years relevant industry experience and / or equivalent experience in a relevant academic environment
Experience working in cross-functional, multicultural and international teams
Experience with requirements from government regulatory agencies with deep understanding of industry best practices
Expertise in regulatory laboratory guidelines
Strong leadership and management skills. Excellent analytical skills, ability to address complex problems through investigation and analysis
Outstanding written and verbal communication skills, with the ability to present complex scientific concepts to diverse audiences
Strong networking skills and proven experience collaborating with external partners

Closing date for applications Friday 21st August 2026

Location: Melbourne CBD

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 https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

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.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

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.

Apply Now

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Job Description

About CSL Behring

Our Benefits

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Equal Opportunity Employer

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