AD or Sr Manager, Clinical Quality and ComplianceAscentage Pharma – Sydney NSWFull time1d ago , from Illawarra Mercury Job BoardAscentage Pharma (NASDAQ: AAPG, HKEX: ****) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers and other diseases.
We focus on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death in treating solid tumors and hematologic malignancies.
The company has built a solid pipeline with innovative drug candidates, including novel, highly potent selective Bcl-2 (Lisaftoclax), and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs).
We launched Olverembatinib and Lisaftoclax for treating CML and CLL/SLL in the market.
The company is conducting more than 40 clinical trials, including 7 global registrational phase III studies, in US, Australia, Europe, China and other regions.
( Opportunity: Sr Manager/AD (depending on experience), Clinical Quality Assurance and ComplianceJob Description Summary: This position as QA lead in the Australian office will head up and execute quality assurance strategy and compliance activities to support the clinical development of Ascentage's pipeline in Australia.
This position is open to senior manager/AD levels depending on the candidates' depth of knowledge, skills, and relevant experience in the field.




Tasks and responsibilitiesLead and execute overall quality assurance strategies to support clinical development in Ascentage Australian office.Define and execute general quality assurance activities in collaboration with Clinical Operation, and other functional teams within the company including deviation management, CAPA management.Participate review, comment and revision of Ascentage SOPs/WIs or other quality management related documents with global stakeholders within Ascentage family.Provide SOP clarification, GxP (GCP, GMP) guidance or other quality advice to support clinical development in Australian office.Develop and implement risk management strategy to support clinical operation; follow and perform trend analyses to identify potential risks in clinical operation, propose, develop risk mitigation plan with management, and participate in the implementing the plan.Develop and implement vendor management strategy including qualification assessment, regular vendor review, maintaining qualified vendor list.Lead and conduct on-site study site audits, develop and maintain audit tools, checklists, and plans, and author or review audit reports and other audit-related documentation; ensures timely communication of quality and/or compliance issues, including critical audit findings, potential misconduct, or points of significant deviation to stakeholders and management.Proactively monitor and assess emerging regulatory requirements, guidance,



and industry standards to identify compliance impacts and risks.Partner with cross-functional stakeholders to ensure regulatory changes are effectively communicated, implemented, and embedded within policies, procedures, and business processes to maintain ongoing compliance.Qualifications:Bachelor's degree or higher in a scientific or healthcare discipline preferred.5 years or above of progressive experience in clinical research or clinical operations within the biotech, pharmaceutical sector or CRO industry.3 year or above of Quality Compliance or Quality Assurance experience.Exhibits a strong understanding of methodologies and approaches.Knowledge and application of relevant TGA Regulations, GCP and ICH guidelines in clinical trials required.Regulatory authority inspection experience preferred.Strong written and verbal communication skills.Applicant must have full working rights in Australia to be considered.Culture - At Ascentage Pharma, we strive to create a culture based on personal and professional growth and opportunity, focusing on these principles: Establish a cooperative, energized, and fun work environment where people are empowered and supported in achieving their career goals.
Working at Ascentage allows you to balance your priorities.
Create a diverse and multi-disciplinary workforce where all levels of within the organization are empowered to lead best welcomes innovation and supports your career goals.
Hire dedicated, talented, and entrepreneurial people who are passionate about achieving excellence in all they do every day, have a commitment to science and the patients we serve.
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📌 Ad Or Sr Manager, Clinical Quality And Compliance (New South Wales)
🏢 Ascentage Pharma
📍 New South Wales