This hybrid role could be based at any of these AbbVie's locations North Chicago, IL Worcester, MA, Irvine, CA and San Francisco, CA
Position Purpose
The Senior Manager, Clinical Product Supply Quality Assurance provides strategic quality leadership and oversight for AbbVie’s clinical development pipeline. This role is accountable for ensuring the timely delivery of high-quality, compliant clinical supplies from drug substance and drug product through finished product while enabling development milestones and protecting patient safety.
As a senior quality partner to Research and Development, the role shapes program strategy, anticipates and mitigates supply and compliance risks, and influences decisions across Quality, CMC stakeholders, and external partnerships. The position also provides quality leadership for integration activities, collaborations, and due diligence assessments, ensuring that proposed strategies, commitments, controls, and risks are identified and mitigated per AbbVie’s quality standards and business objectives.
The successful candidate is a strategic and credible quality leader who operates effectively while working cross functionally and globally. This individual is expected to anticipate risks, elevate critical issues appropriately, and make recommendations that ensure quality, patient safety, regulatory compliance while maintaining development timelines.
The role requires executive presence, strong influencing skills, and the ability to convert complex technical and quality information into clear decisions and actionable outcomes for the CMC team and leadership.
Key Responsibilities
- Provide strategic QA oversight for assigned clinical development programs, including quality strategy, risk management, issue escalation, and executive-level communication of program status and critical decisions.
- 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 interactions.
- Build alignment across R&D, Quality, CMC stakeholders, and external stakeholders, influencing decisions at the team level.