Associate Director Quality Assurance North America and South America
hace 1 día
Bakersfield
Ascentage Pharma – Who we are: Ascentage Pharma 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. Associate Director, Quality Assurance (QA), GCP Clinical Site, Laboratory & Vendor Oversight North America and South America Ascentage Pharma is seeking an experienced and highly motivated Associate Director, Quality Assurance (QA), GCP to provide strategic and operational quality oversight for Phase I-III global clinical development programs. This role will be responsible for GCP quality oversight of clinical investigator sites, central and specialty laboratories, CROs, and other GxP vendors supporting clinical studies across North and South America regions. Position Overview The Associate Director will serve as a key Quality partner to Clinical Operations, Medical Affairs, Biometrics, Pharmacovigilance, Regulatory Affairs, and external service providers to ensure compliance with ICH-GCP, applicable global regulations, and Ascentage quality standards. The role will also lead and support inspection readiness activities for high-enrolling, strategic, and high-risk clinical sites and vendors, ensuring continuous state of inspection readiness across the clinical portfolio. Key Responsibilities Clinical Site Quality Oversight • Develop and execute risk-based GCP quality oversight programs for Phase I-III clinical trials., • Conduct investigator site audits, for-cause audits, and process audits across global clinical programs., • Provide proactive oversight of high-enrolling, critical, and strategically important clinical sites., • Evaluate site compliance with protocol requirements, GCP regulations, informed consent processes, data integrity, patient safety, investigational product accountability, and essential documentation., • Collaborate with Clinical Operations and study teams to identify quality trends and emerging compliance risks., • Support root cause investigations, CAPA development, effectiveness verification, and risk mitigation activities. Laboratory Quality Oversight • Plan and conduct audits of central laboratories, specialty laboratories, bioanalytical laboratories, and sample management facilities., • Assess laboratory compliance with applicable GCP, GLP, GCLP, and regulatory requirements., • Ensure laboratory processes support data reliability, traceability, chain of custody, sample integrity, and patient safety., • Evaluate laboratory quality systems and support remediation activities when required. Vendor & CRO Oversight • Lead qualification, routine surveillance, and for-cause audits of CROs, central service providers, technology vendors, imaging vendors, logistics providers, and other outsourced partners., • Assess vendor quality systems and operational performance against applicable regulations and contractual obligations., • Partner with Vendor Management and Clinical Operations to establish risk-based oversight strategies., • Review vendor quality metrics, deviations, CAPAs, inspection histories, and performance indicators., • Support vendor governance meetings and quality business reviews. Inspection Readiness & Regulatory Support • Lead inspection readiness activities for high-enrolling, critical, and high-risk clinical sites across global studies., • Support preparation for FDA, EMA, MHRA, PMDA, NMPA, and other global health authority inspections., • Conduct mock inspections, inspection simulations, and quality gap assessments., • Participate in inspection war rooms and provide expert QA support during regulatory inspections., • Review inspection responses, commitments, remediation plans, and CAPA implementation activities., • Partner with study teams to maintain a continuous state of inspection readiness throughout the clinical trial lifecycle. Quality Systems & Compliance • Support implementation and continuous improvement of global GCP quality systems., • Review and trend audit findings, quality events, protocol deviations, vendor issues, and compliance metrics., • Contribute to development and revision of SOPs, work instructions, guidance documents, and training materials., • Promote Quality-by-Design and risk-based quality management principles across clinical development programs., • Identify systemic quality risks and recommend sustainable corrective and preventive actions. Leadership & Strategic Contributions • Serve as a trusted QA advisor to clinical development leadership and cross-functional teams., • Influence quality strategy and risk management decisions for global clinical programs., • Mentor junior QA professionals and contribute to organizational capability development., • Represent Quality Assurance on study teams, governance committees, and vendor oversight forums., • Support regulatory intelligence and implementation of evolving global GCP requirements. Education, Experience and Skills Education • Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biology, Chemistry, or related discipline required., • Advanced degree (MS, PharmD, PhD, MPH, or equivalent) preferred., • Professional certifications such as CQA, RQAP-GCP, or equivalent desirable. Experience • Minimum 10+ years of pharmaceutical, biotechnology, CRO, or regulatory agency experience., • Minimum 7+ years of progressive GCP Quality Assurance experience supporting global clinical trials., • Experience auditing investigator sites, CROs, laboratories, and clinical vendors., • Strong experience supporting Phase I, II, and III oncology clinical studies preferred., • Demonstrated experience supporting global regulatory inspections and sponsor inspection readiness programs., • Experience supporting studies conducted in Eastern Europe, Middle East, Asia-Pacific, and other international regions strongly preferred., • Experience with risk-based quality management and quality oversight methodologies. Knowledge & Skills • Extensive knowledge of ICH E6(R2)/(R3), FDA, EMA, MHRA, and global GCP regulations., • Strong understanding of clinical trial conduct, oversight, monitoring, data integrity, and patient safety requirements., • Deep expertise in clinical site auditing, vendor auditing, and laboratory auditing., • Strong understanding of inspection management, inspection readiness, and CAPA effectiveness., • Excellent analytical, risk assessment, investigation, and problem-solving skills., • Demonstrated ability to influence stakeholders without direct authority., • Strong written and verbal communication skills., • Ability to work effectively within global, multicultural, and matrix organizations., • Willingness to travel internationally (approximately 25-40%). Core Competencies • Strategic Quality Leadership, • GCP Expertise, • Inspection Readiness, • Clinical Site Oversight, • Vendor Quality Management, • Laboratory Oversight, • Risk-Based Quality Management, • Regulatory Inspection Support, • Cross-Functional Collaboration, • CAPA and Root Cause Analysis, • Data Integrity and Patient Safety Focus, • Continuous Improvement Mindset Success Measures - Within the first 12 months, the Associate Director will: • Establish effective risk-based oversight of assigned clinical sites, laboratories, and vendors., • Ensure inspection readiness of high-enrolling and strategically important clinical sites., • Successfully execute GCP audit programs across global Phase I-III studies., • Drive timely closure and effectiveness verification of audit CAPAs., • Enhance proactive quality risk identification and mitigation across clinical development programs., • Contribute to successful regulatory inspections with minimal or no significant GCP observations., • Strengthen Ascentage's global culture of quality, compliance, and continuous inspection readiness. Work Location & Schedule • Location Preference: This role is based in the US, and will have responsibility for South America region. Willingness to travel internationally (approximately 25-40%). About Ascentage Pharma Ascentage Pharma (NASDAQ: AAPG and HKEX: 6855) is a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and age-related diseases. In January of 2025 Ascentage went public on NASDAQ. In July 2025 we announced that our proprietary novel Bcl-2 selective inhibitor Lisaftoclax has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma. In May of 2026 at ASCO Ascentage Pharma announced that is currently in nine registration trials, four of which are global studies intended for FDA and EMA filings.
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