Product Quality Senior Manager (Science)
AbbVie
August 29, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Operations
Responsibilities:
- Maintain primary quality lead with management oversight to achieve on-time quality deliverables, customer value, and profitable results; drive quality and compliance for product transfers and organization optimization.
- Develop and implement global Product Quality Assurance strategy for pharmaceuticals, biologics, devices, and combination products at AbbVie and third-party manufacturing (TPM) facilities.
- Perform final quality release of manufactured product lots prepared by Third Party Manufacturers.
- Recommend key decisions on product quality, compliance, and regulatory conformance; elevate medium/high risk events; ensure Quality and Technical Agreements align with legal contracts and commitments are fulfilled.
- Establish and maintain relationships with Third Party Manufacturers, AbbVie plants, affiliates, and functional groups; communicate roles/responsibilities and provide guidance on quality concerns.
- Communicate/negotiates with external quality organizations to maintain consistent quality expectations, minimize compliance risks, and balance operating cost.
- Interface with Quality Assurance audit teams to develop audit/due diligence/inspection readiness plans; review observations/responses; maintain corrective action timetables; lead pre-approval inspection readiness for TPMs.
- Support new product launches; coordinate compliant trend investigations for non-medical/medical (adverse events); manage exception documents and CAPAs.
- Conduct management reviews with TPMs; review Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) for accuracy, completeness, timeliness, and trends.
Qualifications:
- Bachelor’s degree in Life Science, Engineering, or other technical discipline; technical/analytical background for problem resolution.
- 8+ years total experience; 3+ years in Quality Assurance Operations Management and/or 5+ years in Operations, R&D, Regulatory, or Consulting; direct pharmaceutical manufacturing plant experience preferred.
- Expertise in biological/pharmaceutical technologies (e.g., sterile, liquid/solids, devices, tablets/caplets, suspensions, granulations, capsules/gel caps, extended release, coating solutions, APIs).
- Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background.
- FDA and other regulatory inspections/interaction experience required.
- Familiarity with third-party external manufacturing requirements.
- Strong urgency, analytical/problem-solving, interpersonal skills; ability to manage multiple complex tasks and lead.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).
- Eligible for long-term incentive programs.
Application instructions:
- Not specified in the provided text.
- Maintain primary quality lead with management oversight to achieve on-time quality deliverables, customer value, and profitable results; drive quality and compliance for product transfers and organization optimization.
- Develop and implement global Product Quality Assurance strategy for pharmaceuticals, biologics, devices, and combination products at AbbVie and third-party manufacturing (TPM) facilities.
- Perform final quality release of manufactured product lots prepared by Third Party Manufacturers.
- Recommend key decisions on product quality, compliance, and regulatory conformance; elevate medium/high risk events; ensure Quality and Technical Agreements align with legal contracts and commitments are fulfilled.
- Establish and maintain relationships with Third Party Manufacturers, AbbVie plants, affiliates, and functional groups; communicate roles/responsibilities and provide guidance on quality concerns.
- Communicate/negotiates with external quality organizations to maintain consistent quality expectations, minimize compliance risks, and balance operating cost.
- Interface with Quality Assurance audit teams to develop audit/due diligence/inspection readiness plans; review observations/responses; maintain corrective action timetables; lead pre-approval inspection readiness for TPMs.
- Support new product launches; coordinate compliant trend investigations for non-medical/medical (adverse events); manage exception documents and CAPAs.
- Conduct management reviews with TPMs; review Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) for accuracy, completeness, timeliness, and trends.
Qualifications:
- Bachelor’s degree in Life Science, Engineering, or other technical discipline; technical/analytical background for problem resolution.
- 8+ years total experience; 3+ years in Quality Assurance Operations Management and/or 5+ years in Operations, R&D, Regulatory, or Consulting; direct pharmaceutical manufacturing plant experience preferred.
- Expertise in biological/pharmaceutical technologies (e.g., sterile, liquid/solids, devices, tablets/caplets, suspensions, granulations, capsules/gel caps, extended release, coating solutions, APIs).
- Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background.
- FDA and other regulatory inspections/interaction experience required.
- Familiarity with third-party external manufacturing requirements.
- Strong urgency, analytical/problem-solving, interpersonal skills; ability to manage multiple complex tasks and lead.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) (eligible employees).
- Eligible for long-term incentive programs.
Application instructions:
- Not specified in the provided text.