Quality Assurance Manager
vor 1 Woche
Location: Sydney . CBD, Inner West & Eastern Suburbs
Industry: Healthcare & Medical . Clinical/Medical Research
Position: Full time
Description: Please see the position details below and use the below form to apply.
" * " indicates required fields
First name *
Family name
Email *
Attach Resume * Drop files here or Accepted file types: doc, docx, xls, xlsx, pdf, Max. file size: 128 MB.
Quality Assurance ManagerAbout us
Scientia Clinical Research (SCR) is the first publicly funded purpose built early phase clinical trials centre in NSW. In addition to first time in human and first time in patient studies the facility also supports other Phase 1/2 trials across a broad range of therapeutic areas. You will work with a cross-functional team of medical, clinical, scientific, nursing, pharmacy, laboratory and data management professionals highly experienced in the early phase development of new medicines. Qualifications & experience
- A science degree in life science or similar areas.
- At least 5 years’ experience within the pharmaceutical, biotechnology and/or CRO environment.
- At least 6 months experience in QA at a dedicated Phase 1 clinical trial centre (investigational site).
- Experience in GCP and other compliance audits and inspections as well as vendor qualification and audits
- High level knowledge of GCP and relevant aspects of other GxPs.
- Experience in electronic QMS platforms (preferably Salesforce)
- Experience in computerized system validation.
- Demonstrated leadership and team management skills.
- Excellent technical and clinical writing skills; excellent computer literacy esp. in standard MS package, eQMS and other databases.
- Excellent organizational and interpersonal skills; including the ability to competently liaise and provide feedback to internal and external collaborators and stakeholders.
Tasks & responsibilities
- Responsible for Quality and Compliance oversight of Phase 1 clinical studies and operational processes to ensure compliance with Scientia Clinical Research (SCR) policy and procedures, protocols and applicable regulatory requirements.
- Collaborate with key stakeholders to identify process gaps, areas for improvement and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements.
- Develop and/or improve governance SOPs, Policies and other Quality Documents in order to streamline processes and drive compliance.
- Serve as GCP and other relevant GxP subject matter expert in the support of clinical study activities.
- Manage vendor and supplier assurance, vendor audits and qualification.
- Management of Scientia’s eISF (SiteDocs) and act as mentor and trainer for relevant clinical study team members
- Manage SCR’s equipment and asset database; ensure compliance with maintenance and calibration requirements; supervise and coordinate computerised system validation activities and act as validation lead.
- Act as a Research Governance Officer and assist CEO in privacy law matters.
- A non-profit organisation offering salary packaging benefit entitlements.
- State-of-the-art facility close to the beach, shops and public transport including the light rail just in front of the building
- Work closely with national and international pharmaceutical and biotechnology stakeholders
If you would like more information about this opportunity, please contact careers@scientiaclinicalresearch.com.au and quote “Quality Assurance Manager”, or apply directly online at the top of this page.
Thank you for your interest.
World-class clinical trial expertise and state of the art facilities.
#J-18808-Ljbffr-
Software Quality Assurance Expert
vor 1 Woche
Sydney, Österreich Ratp Dev VollzeitMain Purpose Software Quality Assurance (SQA) Expert will play a pivotal role in ensuring that quality assurance processes are seamlessly integrated and adhered to throughout the product/s asset lifecycle. They will work closely with project teams to establish and enforce rigorous quality standards, conduct thorough reviews of software ...
-
Manager Safety
vor 1 Tag
Council of the City of Sydney, Österreich Department of Climate Change, Energy, the Environment and Water VollzeitDepartment of Climate Change, Energy, the Environment & Water Government - State (Government & Defence) Do you want your work to make a difference for NSW?Working to protect the state’s environment and heritage.Play a key role in helping NSW deliver clean, reliable, and affordable renewable energy across the state.Full time ongoing opportunitySydney...
-
Senior Manager, Comprehensive Assurance
Gefunden in: beBee S AU - vor 3 Wochen
Sydney, Österreich MMC Corporate VollzeitMarsh McLennan is seeking candidates for the following position based in the Sydney or Melbourne office:Senior Manager, Comprehensive Assurance What can you expect?Reporting to MMC Pacificâs Head of Monitoring & Oversight, this people leader role is responsible for assessing and evaluating effectiveness, efficiency and consistency in implementation of...
-
Safety Assurance Engineer
vor 1 Woche
Sydney, Österreich Airswift VollzeitJob Type Permanent Date Added October 6, 2023 Overview We are currently recruiting experienced Safety Assurance Engineers to work on a portfolio of rail and rolling stock projects. Location- Sydney or Brisbane Duration- Permanent Responsibilities Ensure life cycle safety assurance and compliance with relevant codes and...
-
Airport Manager
vor 2 Wochen
Sydney, Österreich Air Calin VollzeitAircalin, the international airline of New Caledonia, is seeking dynamic individuals with a passion for customer service to fill the role of Sydney Airport Manager:The Airport Manager is responsible for the on-time arrival and departure of all Aircalin flights to/from Sydney. The role includes managing all administrative/ support tasks of the station,...
-
Quality Associate
vor 1 Woche
Sydney, Österreich Scientia Clinical Research (SCR) VollzeitLocation: Sydney . CBD, Inner West & Eastern Suburbs Industry: Healthcare & Medical . Clinical/Medical Research Position: Full time Description: Please see the position details below and use the below form to apply. " * " indicates required fields First name * Family name Email * Attach Resume * Drop files here or Accepted...
-
Build Quality Control Program Manager, DCCD Global Build Quality
Gefunden in: beBee S AU - vor 3 Wochen
Sydney, Österreich Amazon VollzeitDESCRIPTIONAmazon is looking for a Data Center Build Quality Control Program Manager (QCPM) to develop and execute a new, owner-led quality control program for the entire data center life-cycle (construction, final inspection/testing/commissioning, customer turnover, warranty). The QCPM will create the foundation for the build control program and lead...
-
Build Quality Control Program Manager, DCCD Global Build Quality
Gefunden in: beBee S AU - vor 3 Wochen
Sydney, Österreich Amazon VollzeitDESCRIPTIONAmazon is looking for a Data Center Build Quality Control Program Manager (QCPM) to develop and execute a new, owner-led quality control program for the entire data center life-cycle (construction, final inspection/testing/commissioning, customer turnover, warranty). The QCPM will create the foundation for the build control program and lead...
-
Controls and Quality Business Partner
vor 1 Woche
Sydney, Österreich Bupaoptical VollzeitAt Bupa, our purpose is to help people live longer, healthier, happier lives and making a better world. This is at the core of who we are, making us a healthcare provider that strives to deliver meaningful change.The opportunityA rare opportunity has arisen for a Controls and Quality Business Partner to join our esteemed Health Insurance (HI) team, driven by...
-
Build Quality Control Program Manager, DCCD Global Build Quality
Gefunden in: beBee S AU - vor 3 Wochen
Sydney, Österreich Amazon VollzeitDescription Amazon is looking for a Data Center Build Quality Control Program Manager (QCPM) to develop and execute a new, owner-led quality control program for the entire data center life-cycle (construction, final inspection/testing/commissioning, customer turnover, warranty). The QCPM will create the foundation for the build control program and lead...
-
Build Quality Control Program Manager, DCCD Global Build Quality
Gefunden in: beBee S AU - vor 3 Wochen
Sydney, Österreich Amazon VollzeitDescription Amazon is looking for a Data Center Build Quality Control Program Manager (QCPM) to develop and execute a new, owner-led quality control program for the entire data center life-cycle (construction, final inspection/testing/commissioning, customer turnover, warranty). The QCPM will create the foundation for the build control program and lead...
-
SAP Senior Project Manager
vor 1 Woche
Sydney, Österreich ClearCompany VollzeitSAP Senior Project ManagerInitial contract until April 2025 with a view to extending $1198 per dayHybrid model The primary purpose of the role is to oversee the planning, execution, and successful implementation of SAP projects.This involves managing all aspects of the project lifecycle, including scope definition, timeline management, risk assessment,...
-
Afternoon QA Supervisor
vor 1 Woche
Sydney, Österreich Austcorp Executive Recruitment PTY Ltd VollzeitJob Subject:Based in the Huntingood, Sydney area, the site is highly automated, sophisticated and equipped to global best practice. The company has been built on the foundations of culture, workers safety, excellence and process improvements. This ensures that customer’s product expectations are delivered throughout the companies end to end process. Our...
-
New Product Development
vor 1 Tag
Sydney, Österreich Every Bite Counts (Home of Little Bellies) VollzeitAbout UsEvery Bite Counts is a dynamic, entrepreneurial and innovative FMCG business that is passionate and committed to delivering the very best in children's foods. Our key brand, Little Bellies, is Australia & New Zealand's leading range of baby & toddler snacks. Little Bellies is also expanding internationally and is sold in a number of export markets...
-
Warehouse Manager
Gefunden in: Whatjobs AU C2 - Vor 3 Tagen
Sydney, Österreich Hudson AU VollzeitOur client, a designer and distributor of consumer retail products seeks aWarehouse Managerto be based in their new distribution centre based inSouthwestern Sydney.Full time permanent and career progression opportunities.Join a collaborative and supportive team.Excellent work culture and employee benefitsKey Responsibilities:Logistics Warehouse Cost Control...
-
BMS Project Manager
vor 1 Woche
Sydney, Österreich Austcorp Executive Recruitment PTY Ltd VollzeitWe are currently seeking an experienced BMS (Building Management System) Project Manager to join our client in Sydney. As the BMS Project Manager, you will be responsible for overseeing the successful planning, execution, and completion of BMS projects within the designated timeframe and budget. You will collaborate with cross-functional teams, including...
-
Field Engineer
Vor 5 Tagen
Sydney, Österreich NBN Co VollzeitJob Expectations An exciting opportunity has presented itself to join the Sydney Field Services team as a Field Engineer predominately working on the HFC network. A bit about your role Based in Sydney your new role as Field Engineer would require you to represent nbn’s Field Services team for all field-based assurance activities. You will be responsible...
-
Engineering Manager
vor 1 Tag
Sydney, Österreich HelloFresh VollzeitJOB DESCRIPTION The role As the Engineering Manager for Becool you will be based in Pemulwuy and lead our current development team in shaping the future of logistics and transport. You'll be responsible for analyzing requirements, designing solution architectures, and ensuring efficient software production. This is a fantastic opportunity for someone who...
-
Graduate Podiatrist
vor 2 Wochen
Sydney, Österreich Hapi Healthcare UK Limited VollzeitEmpowering people to live Hapi'er healthier livesWorking as a Podiatrist you'll be joining our team focused on working with, and supporting, a range of clients.Working as a Podiatrist you'll be joining our team focused on working with, and supporting, a range of clients in the...Working as a Podiatrist you'll be joining our team focused on working with, and...
-
Premier Banking Manager, Barangaroo
vor 1 Woche
Sydney, Österreich HSBC VollzeitSome career choices have more impact than others. At HSBC we exist with the purpose of Opening up a World of Opportunity. We use our unique expertise, capabilities, breadth and perspectives to provide opportunities for our customers and colleagues through global connectivity. We bring together the people, ideas and capital that nurture progress and growth,...