Job DescriptionThis 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.
Qualifications- 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-transaction integration.
- In-depth knowledge of applicable global GMP requirements and regulatory expectations, including those of the United States and European Union.
- Quality experience leading complex, cross-functional development programs and external partnerships. Project Management Professional certification or equivalent formal project leadership experience.
- Demonstrated ability to assess complex risks, challenge assumptions constructively, and determine whether proposed quality strategies, controls, timelines, and remediation plans include robust quality and patient safety plans.
- Strong experience with issue management, investigations, exception reports, OOS/OOT, quality agreements, inspection readiness, audits, and product actions/recalls.
- Proven ability to lead through influence, build consensus, and communicate effectively with senior leadership, cross-functional leaders, external partners, and global stakeholders.
- Strong strategic thinking, judgment, problem-solving, project management, and organizational skills, with the ability to manage multiple priorities in a dynamic environment.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
