Senior Manager, Research Laboratory Compliance Specialist

Posted 3 Days Ago
Be an Early Applicant
3 Locations
Remote
Senior level
Biotech
The Role
Lead and govern laboratory compliance across CSL Melbourne research labs and vivarium. Develop compliance frameworks, manage audits/inspections, oversee CAPAs/deviations/change controls and risk registers, govern training and documentation, and partner with QA, EHS, Facilities and research teams to ensure regulatory readiness and continuous improvement.
Summary Generated by Built In

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.

Skills Required

  • Extensive experience in laboratory compliance
  • Minimum of 5 years relevant industry or equivalent academic experience
  • Expertise in regulatory laboratory guidelines and requirements from government agencies
  • Experience managing audits, inspections, deviations, CAPAs, change controls and risk registers
  • Experience collaborating with cross-functional teams (QA, EHS, Facilities, Operations, Research)
  • Strong leadership and management skills with demonstrated analytical problem-solving
  • Outstanding written and verbal communication skills for diverse scientific audiences
  • Postgraduate degree (preferably MSc or PhD) or equivalent extensive experience
  • Proven ability to build external partnerships and stakeholder networks
Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Melbourne, Victoria
20,401 Employees

What We Do

CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra

Similar Jobs

Micron Technology Logo Micron Technology

Gas Engineer, Global Facilities & Construction North Asia

Artificial Intelligence • Hardware • Information Technology • Machine Learning
Remote
Hiroshima, JPN
45000 Employees

Micron Technology Logo Micron Technology

Senior Engineer

Artificial Intelligence • Hardware • Information Technology • Machine Learning
Remote
Hiroshima, JPN
45000 Employees

Micron Technology Logo Micron Technology

Mechanical Engineer, Global Facilities & Construction North Asia

Artificial Intelligence • Hardware • Information Technology • Machine Learning
Remote
Hiroshima, JPN
45000 Employees

Ericsson Logo Ericsson

Developer Thermal Design

Cloud • Information Technology • Internet of Things • Machine Learning • Software • Cybersecurity • Infrastructure as a Service (IaaS)
Remote
Yokohama, Kanagawa, JPN
88000 Employees

Similar Companies Hiring

Formation Bio Thumbnail
Artificial Intelligence • Big Data • Healthtech • Biotech • Pharmaceutical
New York, NY
150 Employees
SOPHiA GENETICS Thumbnail
Software • Healthtech • Biotech • Big Data • Artificial Intelligence
Boston, MA
450 Employees
Pfizer Thumbnail
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
New York, NY
121990 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account