Senior Manager, Clinical Product Supply Quality Assurance

Provide strategic QA oversight for assigned clinical development programs, including quality strategy, risk management, issue escalation, and executive-level communication of program status. Serve as the senior QA representative on CMC and interdisciplinary product development teams, enabling the successful progression of investigational products into clinical trials in accordance with program timelines and global regulatory expectations. Establish and defend risk-based quality positions for complex technical, manufacturing, analytical, supply, and compliance matters, providing clear recommendations to senior R&D leadership and cross-functional governance bodies. Lead the identification, assessment, and mitigation of quality and supply risks across the product lifecycle, including risks associated with drug substance, drug product, analytical testing, manufacturing, packaging, release, distribution, and clinical supply continuity. Provide QA leadership for internal and external integration activities, including in-licensing, collaborations, acquisitions, and onboarding of third-party manufacturers, laboratories, and service providers. Lead or oversee quality assessments supporting due diligence activities. Evaluate the reasonableness, completeness, quality, compliance, and sustainability of proposed plans, assumptions, controls, timelines, remediation commitments, and risk mitigations. Translate due diligence findings into actionable recommendations, including identification of material quality risks, potential value leakage, integration dependencies, required remediation, and decision points for executive leadership. Collaborate with partners to ensure appropriate quality agreements are established and maintained with third-party manufacturers, testing laboratories, service providers, development partners, and internal sites. Lead complex, global, cross-functional process improvement initiatives that strengthen clinical supply quality, operational effectiveness, compliance, inspection readiness, and organizational consistency. Provide oversight and direction for complex investigations, exception reports, deviations, and product quality actions, including high-impact issues affecting multiple functions, sites, products, or clinical programs. Provide QA oversight for clinical supply product actions, including recalls or other market and patient-impacting actions, ensuring timely, coordinated, and compliant execution. Support regulatory inspection and internal audit readiness and represent Quality during inspections, audits, partner assessments, and other regulatory or governance