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Senior Manager, Research Laboratory Compliance Specialist

CSL · Melbourne, Victoria

Type
Full-time
Posted
Yesterday

Overview

Your experience managing regulatory frameworks like PACE and CPIA gives you a foundation in compliance and audit readiness, but this role requires deep knowledge of laboratory research regulations, biosafety, and vivarium operations that policing typically does not cover. The strategic governance and multi-stakeholder coordination aspects might draw on your incident command and leadership skills, but the technical gaps are significant.

About this role

Entity: CSL Behring

Job Category: Research Development & Sciences

Job Family: Discovery & Product Development

Job Type: Full Time

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

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.

About compliance & regulatory roles for ex-police

Compliance, AML/CTF and regulatory roles. Working to AUSTRAC, ASIC and APRA obligations is a stronger regulatory grounding than most civilian applicants can offer — firms increasingly recognise this.

See all compliance & regulatory jobs in Melbourne →

Why this fits a police background

  • Investigative casework
  • Risk & threat assessment
  • Working to legislation & regulation

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