Quality Assurance Specialist

About Ascentage Pharma

Ascentage Pharma is a global biopharmaceutical company specializing in innovative treatments for cancers and other diseases. They develop therapies that target protein-protein interactions to restore apoptosis and treat solid tumors and hematologic malignancies. Their portfolio includes potent selective Bcl-2 inhibitors like Lisaftoclax and dual Bcl-2/Bcl-xL inhibitors, alongside candidates targeting IAP and MDM2-p53 pathways and next-generation TKIs. They market products such as Olverembatinib and Lisaftoclax for CML and CLL/SLL and conduct over 40 clinical trials worldwide.

Role Overview

As the Quality Assurance lead based in the Australian office, you will spearhead and implement quality assurance strategies and ensure compliance to support clinical development efforts. This senior manager or associate director role depends on your experience and expertise in clinical quality assurance.

Key Responsibilities

• Lead and execute quality assurance strategies aligned with clinical development initiatives at the Australian office.
• Collaborate with Clinical Operations and other teams on general QA tasks including deviation and CAPA management.
• Review, provide feedback, and revise SOPs, work instructions, and other quality management documentation alongside global stakeholders.
• Offer SOP clarifications and GxP guidance (GCP, GMP) to support clinical activities in Australia.
• Develop and put in place risk management strategies, conducting trend analyses to identify potential clinical operational risks and proposing mitigation plans.
• Implement vendor management strategies such as qualification assessments, ongoing reviews, and maintenance of qualified vendor lists.
• Lead site audits including preparation of audit tools, checklists, and plans; author and review audit reports; and ensure timely communication of critical findings or deviations.
• Monitor emerging regulatory requirements and industry standards, collaborating with stakeholders to embed necessary changes into policies and processes to ensure compliance.

Qualifications and Experience

• Bachelor’s degree or higher in a scientific or healthcare discipline preferred.
• Minimum of 5 years progressive experience in clinical research or operations within biotech, pharmaceuticals, or CRO sectors.
• At least 3 years of experience in Quality Compliance or Quality Assurance roles.
• Strong understanding of QA methodologies and approaches.
• In-depth knowledge and practical application of TGA Regulations, GCP, and ICH guidelines for clinical trials.
• Experience with regulatory authority inspections is advantageous.
• Excellent verbal and written communication skills.
• Must have full legal authorization to work in Australia.

Company Culture

• Foster a collaborative, energized, and supportive work environment empowering career growth and work-life balance.
• Promote diversity and inclusivity with empowered leadership at all levels encouraging innovation.
• Hire passionate and dedicated individuals committed to scientific excellence and patient-focused outcomes.