Senior Manager, Clinical Product Supply Quality Assurance
AbbVie
August 19, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Operations
Position Purpose
Senior Manager, Clinical Product Quality Assurance provides strategic quality leadership and oversight for AbbVie’s clinical development pipeline, ensuring timely delivery of high-quality, compliant clinical supplies (drug substance/drug product through finished product) while enabling development milestones and protecting patient safety.
Key Responsibilities
- Provide strategic QA oversight for assigned clinical development programs (quality strategy, risk management, issue escalation, executive-level program status/critical decisions).
- Serve as senior QA representative on CMC and interdisciplinary product development teams to progress investigational products into clinical trials per timelines and global regulatory expectations.
- Establish/defend risk-based quality positions for complex technical, manufacturing, analytical, supply, and compliance matters.
- Lead identification, assessment, and mitigation of quality and supply risks across the product lifecycle (DS/DP, analytical testing, manufacturing, packaging, release, distribution, clinical supply continuity).
- Provide QA leadership for integration activities (in-licensing, collaborations, acquisitions, onboarding third parties).
- Lead/oversee quality assessments supporting due diligence; translate findings into actionable recommendations for executives.
- Ensure appropriate quality agreements with partners/third parties.
- Lead process improvement initiatives; oversee investigations/deviations/exception reports/product quality actions.
- Provide QA oversight for clinical supply actions (e.g., recalls) and support inspection/audit readiness.
Qualifications
- BS in life sciences/chemistry/biology/engineering/pharmaceutical sciences or related (MS preferred).
- 8+ years industry experience in QA, production/testing of APIs/drug products, drug development, or healthcare.
- Experience in pharmaceutical development/clinical product supply/QA/GMP/analytical testing.
- Broad knowledge of pharmaceutical manufacturing/testing (DS/DP/finished product, chemical/biological).
- Due diligence/in-licensing/collaborations/M&A/technology transfers/post-transaction integration experience.
- In-depth global GMP/regulatory knowledge (US/EU).
- Ability to assess complex risks; strong issue management/investigations/OOS-OOT/quality agreements.
- Lead through influence; strong communication with senior leadership and global stakeholders.
Benefits (as stated)
- Paid time off; medical/dental/vision; 401(k) eligibility; eligibility for long-term incentive programs.
Senior Manager, Clinical Product Quality Assurance provides strategic quality leadership and oversight for AbbVie’s clinical development pipeline, ensuring timely delivery of high-quality, compliant clinical supplies (drug substance/drug product through finished product) while enabling development milestones and protecting patient safety.
Key Responsibilities
- Provide strategic QA oversight for assigned clinical development programs (quality strategy, risk management, issue escalation, executive-level program status/critical decisions).
- Serve as senior QA representative on CMC and interdisciplinary product development teams to progress investigational products into clinical trials per timelines and global regulatory expectations.
- Establish/defend risk-based quality positions for complex technical, manufacturing, analytical, supply, and compliance matters.
- Lead identification, assessment, and mitigation of quality and supply risks across the product lifecycle (DS/DP, analytical testing, manufacturing, packaging, release, distribution, clinical supply continuity).
- Provide QA leadership for integration activities (in-licensing, collaborations, acquisitions, onboarding third parties).
- Lead/oversee quality assessments supporting due diligence; translate findings into actionable recommendations for executives.
- Ensure appropriate quality agreements with partners/third parties.
- Lead process improvement initiatives; oversee investigations/deviations/exception reports/product quality actions.
- Provide QA oversight for clinical supply actions (e.g., recalls) and support inspection/audit readiness.
Qualifications
- BS in life sciences/chemistry/biology/engineering/pharmaceutical sciences or related (MS preferred).
- 8+ years industry experience in QA, production/testing of APIs/drug products, drug development, or healthcare.
- Experience in pharmaceutical development/clinical product supply/QA/GMP/analytical testing.
- Broad knowledge of pharmaceutical manufacturing/testing (DS/DP/finished product, chemical/biological).
- Due diligence/in-licensing/collaborations/M&A/technology transfers/post-transaction integration experience.
- In-depth global GMP/regulatory knowledge (US/EU).
- Ability to assess complex risks; strong issue management/investigations/OOS-OOT/quality agreements.
- Lead through influence; strong communication with senior leadership and global stakeholders.
Benefits (as stated)
- Paid time off; medical/dental/vision; 401(k) eligibility; eligibility for long-term incentive programs.