Product Quality Senior Manager (Science)
AbbVie
August 07, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Operations
Job Description
Responsible for quality of assigned products (small molecule pharmaceuticals/biologics, combination products, and medical devices) to meet business objectives, including on-time delivery, while ensuring compliance with local/divisional/corporate policies and external agency regulations worldwide. Develops regulatory strategies with Regulatory Affairs.
Responsibilities
- Maintain primary quality lead with oversight to achieve on-time quality deliverables, customer value, and profitable results; drive quality/compliance for product transfers and organization optimization.
- Develop and implement global Product Quality Assurance strategy for pharmaceuticals, biologics, devices, and combination products at AbbVie plants and third-party manufacturing (TPM) facilities.
- Perform final quality release of manufactured product lots from Third Party Manufacturers.
- Recommend decisions on product quality/compliance and regulatory conformance; elevate medium/high risk events; ensure alignment of Quality/Technical Agreements with contracts.
- Establish and maintain relationships with TPMs, AbbVie plants, affiliates, and functional groups; guide quality concerns.
- Communicate/negotiates with external quality organizations to balance quality expectations and operating cost; prioritize initiatives considering timelines/resources.
- Partner with QA audit team on audit/due diligence/inspection readiness; review observations/responses; lead pre-approval inspection readiness.
- Support new product launches, compliant trend investigations (medical/non-medical), exceptions, and CAPA.
- Conduct management reviews with TPMs; review Annual Product Reviews (domestic) and Annual Product Quality Reports (EU).
Qualifications
- Bachelor’s degree in Life Science, Engineering, or technical discipline; technical/analytical background for problem resolution.
- 8+ years combined experience; at least 3 years in Quality Assurance Operations Management; 5+ years in Operations, R&D, Regulatory, or Consulting (direct pharmaceutical manufacturing plant experience preferred).
- Expertise in biological/pharmaceutical technologies (e.g., sterile/biological/liquid/solids/devices, capsules, extended release, coatings, API).
- Strong QA/control, manufacturing, laboratory, technical support, regulatory, and/or validation background.
- Experience with FDA and other regulatory agency inspections/interactions.
- Familiarity with third-party external manufacturing requirements.
- Urgency, analytical/problem-solving, interpersonal, and ability to manage multiple complex tasks.
Responsible for quality of assigned products (small molecule pharmaceuticals/biologics, combination products, and medical devices) to meet business objectives, including on-time delivery, while ensuring compliance with local/divisional/corporate policies and external agency regulations worldwide. Develops regulatory strategies with Regulatory Affairs.
Responsibilities
- Maintain primary quality lead with oversight to achieve on-time quality deliverables, customer value, and profitable results; drive quality/compliance for product transfers and organization optimization.
- Develop and implement global Product Quality Assurance strategy for pharmaceuticals, biologics, devices, and combination products at AbbVie plants and third-party manufacturing (TPM) facilities.
- Perform final quality release of manufactured product lots from Third Party Manufacturers.
- Recommend decisions on product quality/compliance and regulatory conformance; elevate medium/high risk events; ensure alignment of Quality/Technical Agreements with contracts.
- Establish and maintain relationships with TPMs, AbbVie plants, affiliates, and functional groups; guide quality concerns.
- Communicate/negotiates with external quality organizations to balance quality expectations and operating cost; prioritize initiatives considering timelines/resources.
- Partner with QA audit team on audit/due diligence/inspection readiness; review observations/responses; lead pre-approval inspection readiness.
- Support new product launches, compliant trend investigations (medical/non-medical), exceptions, and CAPA.
- Conduct management reviews with TPMs; review Annual Product Reviews (domestic) and Annual Product Quality Reports (EU).
Qualifications
- Bachelor’s degree in Life Science, Engineering, or technical discipline; technical/analytical background for problem resolution.
- 8+ years combined experience; at least 3 years in Quality Assurance Operations Management; 5+ years in Operations, R&D, Regulatory, or Consulting (direct pharmaceutical manufacturing plant experience preferred).
- Expertise in biological/pharmaceutical technologies (e.g., sterile/biological/liquid/solids/devices, capsules, extended release, coatings, API).
- Strong QA/control, manufacturing, laboratory, technical support, regulatory, and/or validation background.
- Experience with FDA and other regulatory agency inspections/interactions.
- Familiarity with third-party external manufacturing requirements.
- Urgency, analytical/problem-solving, interpersonal, and ability to manage multiple complex tasks.