Senior Operational Services Associate –Change Projects
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Key skills for this role
Key Skills for This Role
Full Job Posting
Key Responsibilities
- Execute and coordinate changes through the Change Management System according to agreed priorities and timelines.
- Lead deviation investigations and support robust CAPA development.
- Ensure strong compliance, documentation, and evidence management practices.
- Facilitate cross-functional teams to complete investigations, changes, and improvement initiatives.
- Build strong partnerships with Manufacturing, Quality, Engineering, and Safety stakeholders.
- Analyse trends to identify opportunities for process improvement and simplification.
- Support capability development through coaching, knowledge sharing, and practical guidance.
Preferred Skills & Experience
- A tertiary qualification in Science, Engineering or a related discipline, or equivalent experience within a regulated manufacturing environment.
- Experience in pharmaceutical, biotechnology, biologics or other GMP-regulated manufacturing environments.
- Demonstrated experience managing deviations, CAPAs, audits, inspections and/or change management activities, with a strong focus on compliance outcomes.
- Strong understanding of manufacturing operations, GMP requirements and continuous improvement within a live production environment.
- Proven ability to facilitate cross-functional teams, influence stakeholders and drive investigations or change initiatives to successful completion.
- Excellent analytical, root cause investigation, organisational and technical writing skills. Experience with Veeva and/or TrackWise is highly regarded.
How to Apply
- Apply now to step into a varied and impactful role within an organisation undergoing significant investment and transformation. Please include your CV and Cover Letter with your application.
- We are committed to attracting talented individuals from diverse backgrounds. If you are interested in this opportunity and can demonstrate many, but not all, of the capabilities required, we encourage you to apply.
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 CSL Behring
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CSL
Global biotechnology company developing biotherapies and vaccines.
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