Associate Director Quality Assurance

About the job

Ascentage Pharma – Who we are:

Ascentage Pharma (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. Ascentage Pharma is proud of its collaborative and supportive culture, unified by a shared desire to develop therapeutics that will have a positive impact on patients’ lives. Ascentage Pharma is a dynamic and fast-paced organization that has been responsive to the needs of individual employees throughout its history. The company is defined by a shared understanding that it succeeds in advancing its mission only as each experience’s success in their role. Following our recent IPO on NASDAQ, we are expanding our U.S. leadership team to support financial compliance, reporting rigor, and scalable growth in a complex, multinational environment.

role.

Associate Director, Quality Assurance

Reporting to Vice President of Regulatory Affairs

Location: Remote (preference for candidates in the DMV area)

Primary Duties and Responsibilities:

Lead and provide overall quality assurance strategies for Ascentage clinical development. Define and execute overall quality assurance activities in collaboration with Clinical Operation, pharmacovigilance and CMC. Have thorough knowledge of GCP, EU Directives, ICH, and are familiar with current and emerging US and global guidelines and regulations and apply in the company’s clinical studies for the development of quality risk mitigation strategies. Perform risk assessments to identify audit targets, conduct internal and vendor audits, develop and maintain audit tools, checklists and plans, and author or review audit reports and other audit-related documentation. Ensures timely communication of QA issues including critical audit findings, potential misconduct or issues of significant deviation to stakeholders and management. Define and implement the health authority inspection strategies in support of the submissions and GCP compliance.

Knowledge/Skills/Abilities Required

• BS in Sciences required; advanced degree highly preferred.
• Must have 8+ years of pharmaceutical or biotech industry experience.
• Must have 5+ years of hands-on quality assurance lead experience.
• 3+ years of clinical trial monitoring and/or pharmacovigilance experience.
• Experience in leading internal and vendor audit is essential.
• Experience in leading FDA and other health authorities’ inspection are highly preferred.

Why Join Us- Our Value Proposition

This is a rare opportunity to shape the clinical vision of a public biotech at a pivotal growth moment—and see your work make a tangible impact for patients. If you want to do something that matters—this work matters. Patients drive our passion to pioneer novel cancer therapies. Creating and delivering life-changing medicines requires focus, dedication, and heart. We hire exceptional people, trust them to do their best work, and support them with the resources and flexibility to thrive.

What We Offer

• Exciting, supportive, and intellectually challenging global work environment.
• Competitive benefits, including medical, dental, vision, disability, and life insurance, parental leave, and a matching 401(k) program (immediate vesting).
• Generous PTO and holidays encourage balance and recharge.
• A culture of engagement, diversity, inclusion, and empowerment.
• Flexibility to work onsite, remotely, or in a hybrid model.

Compensation and Benefits

At Ascentage, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity, and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity.