Senior Manager, Clinical Product Supply Quality (all genders) (full-time, regular)

Overview

• 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.
• Bachelor’s degree in life sciences, chemistry, biology, engineering, pharmaceutical sciences, or a related discipline; equivalent experience may be considered. Master’s degree is preferred but is not required based on commensurate experience.
• 8+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or other healthcare related field; less experience considered with advanced degree
• Demonstrated experience in pharmaceutical development, clinical product supply, quality assurance, GMP manufacturing, analytical testing, or related healthcare environments.
• Broad understanding of pharmaceutical manufacturing and testing processes, including chemical and biological products, investigational products, drug substance, drug product, and finished product.
• Experience supporting due diligence, in-licensing, collaborations, mergers and acquisitions, technology transfers, or post-tran

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at  www.abbvie.com . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X  and  YouTube.

Welcome to AbbVie! As part of an international company with 57,000 employees worldwide and around 3,500 employees in Germany, you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care? Do you want to contribute to improving patients' quality of life through your expertise? In a challenging work environment that offers opportunities of developing and increasing your own skills? Youve come to the right place!

Together, we break through – as Senior Manager, Clinical Product Supply Quality (all genders)

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