Manager Digital Quality R&d

3 days ago


Melbourne, Australia CSL Full time

**The Opportunity**:
We are looking for an experienced Quality Manager to join the CSL Digital Quality team on an ongoing basis. Reporting to the Digital Quality R&D Systems Lead you will ensure compliance with GxP regulatory requirements and company policies throughout the lifecycle of computerised systems for the APAC region. You will also be the Subject Matter Expert (SME) and provide quality oversight and approval of change controls, deviations and investigations, CAPAs, and Periodic Review assessments involving GxP computerised systems.

**The Role**:
Based primarily at CSL Melbourne but working flexibly, as the Manager Digital Quality R&D APAC you will work with local and global partners to:

- Participate in project teams to provide review and approval of project Validation documentation according to applicable approval matrix or procedures.
- Participate in vendor / supplier audits / assessments and qualification activities involving GxP computerized systems as an SME.
- Participate in internal GxP audits of computerized systems as an SME.
- Support GxP health authority inspections by serving as SME for computerized systems topics.
- Contribute to continuous QMS improvements and/or supports the development of quality standards in the area of computerized systems.
- Provide guidance on quality and regulatory requirements to project teams, internal partners and other teams on GxP compliance relating to computerized systems.

**Your skills and experience**:
To be considered for this role you have:

- Bachelor's degree or equivalent; education preferably concentrated in IT, Quality, Engineering or Science
- 5+ years' experience in Quality, IT or Validation
- 3+ years' experience in Pharma/Biotech or similarly regulated environment
- 2+ years' experience in Quality Assurance, IT, Quality Control, Validation, Production, or Regulatory Affairs
- Knowledge of GxP, GAMP, FDA and EMA requirements specifically CFR21 part11 and Annex 11
- Experience communicating complex information accurately and effectively including writing technical documents
- The ability to analyse data and situations to support quality decision-making
- Experience in a role requiring initiative and independent work
- The ability to communicate and collaborate with partners and key stakeholders at all levels and across the organisation to influence outcomes.

Please note: This role may require up to 10% travel

**How to apply**:
Please send us your resume and covering letter (in one document), which addresses the criteria above and includes reference number R-232991 by 5 June May 2024.

LI-Hybrid

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL**:
CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL**:


  • R & D Scientist

    1 week ago


    Melbourne, Victoria, Australia Bell People Limited Full time

    Global Pharmaceutical ManufacturerExcxellent Long Term OpporutnityInner Melbourne LocationAbout The CompanyOur client is one of the world's leading manufacturers and suppliers of consumer products and is well known for its operational excellence, passion for innovation and its household quality branded products.An opportunity has now arisen for a R&D...


  • Melbourne, Victoria, Australia Evolve Scientific Full time

    About the company: Our client, a Global Pharmaceutical Company located in Melbourne CBD requires the assistance of Evolve Scientific to source a Senior R&D QA Associate . This is an exciting opportunity to join on a 7 month contract.About the role:This is a Monday to Friday role with some flexibility to some hours from home once fully trained and established...


  • Melbourne, Australia Bell People Consultants Full time

    Leading Pharmaceutical Global Manufacturing Organisation - Virology Background highly desirable - Melbourne Metropolitan Area - Long Term contract **About the company**: Operating as a leading global pharmaceutical manufacturing organisation with global sites worldwide, our client is well known for its growth and innovation and is an Australian iconic brand...


  • Melbourne, Australia BlueRock Full time

    A smart human once said, “Do things you love with people you care about and good things happen”, and at BlueRock, we are a growing team who love what we do. We are looking for an aspirational Manager to join our growing team alongside other entrepreneurial and commercially minded rockstars. This permanent, full-time opportunity plays a key role in...


  • Melbourne, Victoria, Australia BlueRock Full time

    A smart human once said, "Do things you love with people you care about and good things happen", and at BlueRock, we are a growing team who love what we do.We are looking for an aspirational Manager to join our growing team alongside other entrepreneurial and commercially minded rockstars. This permanent, full-time opportunity plays a key role in BlueRock's...


  • Melbourne, Victoria, Australia Blue Rock Full time

    A smart human once said, "Do things you love with people you care about and good things happen", and at BlueRock, we are a growing team who love what we do.We are looking for an aspirational Manager to join our growing team alongside other entrepreneurial and commercially minded rockstars. This permanent, full-time opportunity plays a key role in BlueRock's...


  • Melbourne, Australia BlueRock Full time

    A smart human once said, “Do things you love with people you care about and good things happen”, and at BlueRock, we are a growing team who love what we do.We are looking for an aspirational Manager to join our growing team alongside other entrepreneurial and commercially minded rockstars. This permanent, full-time opportunity plays a key role in...


  • Melbourne, Victoria, Australia BlueRock Full time

    A smart human once said, "Do things you love with people you care about and good things happen", and at BlueRock, we are a growing team who love what we do.We are looking for an aspirational Manager to join our growing team alongside other entrepreneurial and commercially minded rockstars. This permanent, full-time opportunity plays a key role in BlueRock's...


  • Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Manufacturing Organisation - High Level R&D Project Work - Melbourne Metropolitan Area **About the Company** Operating as a progressive and highly respected global pharmaceutical manufacturer with sites worldwide, our client is one of the world's leading manufacturers and suppliers of consumer products and is well known for its...


  • Melbourne, Australia Culture Amp Full time

    **Join us on our mission to make a better world of work.** Culture Amp revolutionizes how over 25 million employees across 6,000 companies create a better world of work. As the global platform leader for employee experience, Culture Amp empowers companies of all sizes and industries to transform employee engagement, develop high performing teams, and retain...


  • Melbourne, Victoria, Australia Bell People Consultants Full time

    Global Pharmaceutical Manufacturing Organisation High Level R&D Project Work Melbourne Metropolitan AreaAbout the CompanyOperating as a progressive and highly respected global pharmaceutical manufacturer with sites worldwide, our client is one of the world's leading manufacturers and suppliers of consumer products and is well known for its operational...


  • Melbourne, Australia AMP Limited Full time

    If you live in Australia or New Zealand, you’ve likely heard of AMP. But at a time when society is changing, we are too. We’re now a nimbler business with new leadership and thinking. For us, these are exciting times. There’s a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even...


  • Melbourne, Australia AMP Limited Full time

    If you live in Australia or New Zealand, you’ve likely heard of AMP. But at a time when society is changing, we are too. We’re now a nimbler business with new leadership and thinking. For us, these are exciting times. There’s a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy into something even...


  • Melbourne, Victoria, Australia Endpoints Capital Pty Limited Full time

    Business Services & Corporate Advisory (Accounting) Endpoints Capital provides financing to companies undertaking eligible R&D activities in Australia.We specialise in providing funding to biotechs and other lifesciences companies and are we now expanding into new industries, which is why we are seeking an experienced R&D tax consultant to join our growing...


  • Melbourne, Victoria, Australia Endpoints Capital Pty Limited Full time

    Business Services & Corporate Advisory (Accounting)Endpoints Capital provides financing to companies undertaking eligible R&D activities in Australia. We specialise in providing funding to biotechs and other lifesciences companies and are we now expanding into new industries, which is why we are seeking an experienced R&D tax consultant to join our growing...


  • Melbourne, Australia AMP Full time

    Digital Product Manager If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn our legacy...


  • Melbourne, Australia BlueRock Full time

    A smart human once said, “Do things you love with people you care about and good things happen”, and at BlueRock, we are a growing team who love what we do.We are looking for an aspirational Consultant to join our growing team alongside other entrepreneurial and commercially minded rockstars. This permanent, full-time opportunity plays a key role in...

  • Nsc Quality Coach

    1 week ago


    Melbourne, Victoria, Australia AMP Limited Full time

    The opportunityThe Quality Coach is responsible for training and ongoing coaching support to complaints resolution specialists, to effectively resolve complaints received within regulatory timeframes.How you will make an impact Review complaint responses and provide feedback and coaching in a timely manner to enhance service the competency of complaints...


  • Melbourne, Australia AMP Full time

    North Service Centre Quality Coach If you live in Australia or New Zealand, you've likely heard of AMP. But at a time when society is changing, we are too. We're now a nimbler business with new leadership and thinking. For us, these are exciting times. There's a real potential for big thinkers to help us redefine what financial services could be. And turn...

  • R&D Engineer

    1 week ago


    Melbourne, Victoria, Australia Australia Wide Engineering Recruitment Full time

    Work for a world leading, innovative organisationLunch providedFully equipped gym on site The Company:Our client, a successful Australian company, has grown to become one of the world's leading innovators and manufacturers for their product design. They are driven by innovation and creativity. Their engineers work with other like minded creative thinkers,...