Position Purpose
The Senior Quality Associate is responsible for managing deviations, investigations, CAPAs, product technical complaints and change controls associated with development activities and manufacture of Investigational Medicinal Product within CSL Clinical Development portfolio.
To do this, the GMP Site Quality Associate has the primary purpose of ensuring compliance with GMP/GSP/GxP by providing front‑line quality guidance and support across all phases of Technical Product Development. You will also ensure self‑inspections are conducted and followed up in a timely manner and provide quality and compliance support throughout all aspects of technical product.
Main Responsibilities and Accountabilities
- Participate in IPT Project and associate delivery team meetings, providing quality/compliance leadership, guidance and advice
- Manage deviations and OOS investigations and facilitate/attend Deviation Review Board meetings as required
- Manage and facilitate the deviation meeting process, manage deviations to closure, including significant and complex deviations, to ensure that information recorded is comprehensive and remedial actions are appropriate and executed in a timely manner
- Facilitate change panel meetings, manage change controls to completion, including significant and complex changes, to ensure changes are appropriate and comply with regulatory requirements
- Liaison with Technical departments for quality assurance and compliance related issues
- Manage Product Technical Complaints and associated investigations
- Review and approve Technical Document Change Requests
- Conduct self‑inspections, provide reports in a timely manner, assess responses and provide quality advice to maintain regulatory compliance and continuous improvement
- Provide training in QMS principles as required
- Participate in updating of QA documents as relevant to Technical Development
- Provide QA compliance review and approval of relevant product documents
- Attend and manage Quality Risk Assessments (QRAs) as required
- Educate technical staff in GxP and quality system requirements
- Establish and maintain local and global product‑related Quality Agreements
Position Qualifications and Experience Requirements
Education
A degree in a relevant biological science, with at least 3 years’ experience in at least one of the following areas:
- Manufacturing under GMP
- Regulatory Affairs
- Quality Assurance
- Relevant Process Development
Essential Skills, Knowledge and Attributes
- In‑depth understanding of GMP requirements in the pharmaceutical industry and previous Production, Quality or R&D experience within the pharmaceutical industry
- Sound knowledge of processes for Clinical Trial GMP manufacture
- Understanding of the product development process and environment is desirable
- Good interpersonal, negotiation and influencing skills
- Ability to relate to and communicate with people of different technical skill backgrounds and at different levels from management to operations within CSL
- Good analytical and problem‑solving skills
- Ability to work well independently and to self‑motivate
- Well‑developed organisational and time management skills
- PC skills (Microsoft Office)
- Strong oral and written communication skills
- Team orientated
- Strong customer focus
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.
