Document/Records Lead

We are seeking an experienced and motivated Site Documentation and Records Management Lead (R&D) to take ownership of site‑level and R&D related document and records management activities within the Quality function.

This role plays a critical part in ensuring compliant, efficient, and audit‑ready document and records management, supporting both local site needs and globally aligned documentation processes. The successful candidate will act as the single point of contact for R&D documentation and records and will provide guidance and support to document coordinators and business stakeholders.

This role can either be based in Broadmeadows or Tullamarine

Key Responsibilities

• Lead site‑level document and records management activities in line with global standards and regulatory requirements.
• Manage paper and electronic records, including archiving, retrieval, storage, and destruction.
• Act as site point of contact for audits, inspections, and document requests.
• Administer documents within the electronic Document Management System (DMS), including formatting, release, and periodic review.
• Support audit readiness, CAPAs, deviations, and change controls related to documentation and records management.
• Provide guidance to document coordinators and collaborate with Quality, R&D, and site stakeholders on documentation matters.
• Contribute to continuous improvement initiatives and global documentation projects.

About You

• Bachelor’s degree in a scientific or life sciences discipline (or equivalent)
• 4–5 years’ experience in the pharmaceutical, biotech, or another highly regulated industry.
• Solid knowledge of cGMP / GxP standards.
• Experience working with electronic Document Management Systems.
• Strong attention to detail and documentation discipline.
• Proficiency in MS Office applications.
• Strong communication and stakeholder engagement skills.

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.