Design Quality, Late-Stage Development Manager
AbbVie
June 24, 2026
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Clinical Research and Development
Job Description
Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure on-time delivery while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Develops Regulatory, Quality and Product Development strategies for NPI products with Regulatory Affairs, marketing, Product Development, and cross-functional stakeholders.
Responsibilities:
- Serve as primary quality lead to achieve on-time quality deliverables, customer value, and profitable results; drive quality and compliance aspects of product transfers and organization optimization.
- Assure integration/support of device, drug, and as appropriate biologics regulations; ensure compliance with company policies/procedures.
- Lead/mentor design control activities: guide product teams through design, ensure robust product vs. customer requirements, participate in design reviews, and ensure interfaces to drug development where applicable.
- Ensure traceability/linkages and design change control documentation; assess change impact on safety/efficacy and justify impact on cumulative changes.
- Identify process gaps; lead cross-functional solution development/implementation.
- Guide combination product project development globally to proactively address quality issues; advise business partners on medical device/combination product regulations.
- Support regulatory inspections and internal audits; represent QA as SME.
- Participate in global Product Quality Assurance strategy and implement for AbbVie plants and contract manufacturing/supplier facilities.
- Bring products through Design Control for on-time launches, including third-party manufacturers and launch support.
- Recommend on product quality/compliance/regulatory conformance decisions; elevate medium/high-risk events.
- Align Quality/Technical Agreements with legal contracts and ensure commitments are fulfilled.
- Maintain supplier/manufacturer/site relationships to identify projects/issues and guide quality concerns; communicate/negotiates with external quality organizations.
- Interface with audit team on audit/due diligence/inspection readiness plans, review observations/responses, manage corrective action timetables; lead pre-approval inspection readiness for contract manufacturers.
Qualifications:
- Bachelor’s degree in relevant Engineering, Life Science, or technical discipline, or equivalent experience.
- 7+ years total combined experience; at least 5 years Operations Quality Assurance and 3 years Operations, R&D, or Consulting.
- Comprehensive knowledge of combination products, medical devices, manufacturing processes; root cause investigations, CAPA, and statistics/data analytics (plus).
- Understanding of regulations/standards for combination products and medical devices; demonstrated quality leadership.
- Technical understanding of product development and/or practical design control experience.
- Risk management methodologies knowledge.
- Strong analytical/problem-solving skills; ability to challenge scientific arguments.
- Ability to work independently in global teams and at all organizational levels.
Responsible for quality of assigned New Product Introduction (NPI) combination products and medical devices to ensure on-time delivery while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Develops Regulatory, Quality and Product Development strategies for NPI products with Regulatory Affairs, marketing, Product Development, and cross-functional stakeholders.
Responsibilities:
- Serve as primary quality lead to achieve on-time quality deliverables, customer value, and profitable results; drive quality and compliance aspects of product transfers and organization optimization.
- Assure integration/support of device, drug, and as appropriate biologics regulations; ensure compliance with company policies/procedures.
- Lead/mentor design control activities: guide product teams through design, ensure robust product vs. customer requirements, participate in design reviews, and ensure interfaces to drug development where applicable.
- Ensure traceability/linkages and design change control documentation; assess change impact on safety/efficacy and justify impact on cumulative changes.
- Identify process gaps; lead cross-functional solution development/implementation.
- Guide combination product project development globally to proactively address quality issues; advise business partners on medical device/combination product regulations.
- Support regulatory inspections and internal audits; represent QA as SME.
- Participate in global Product Quality Assurance strategy and implement for AbbVie plants and contract manufacturing/supplier facilities.
- Bring products through Design Control for on-time launches, including third-party manufacturers and launch support.
- Recommend on product quality/compliance/regulatory conformance decisions; elevate medium/high-risk events.
- Align Quality/Technical Agreements with legal contracts and ensure commitments are fulfilled.
- Maintain supplier/manufacturer/site relationships to identify projects/issues and guide quality concerns; communicate/negotiates with external quality organizations.
- Interface with audit team on audit/due diligence/inspection readiness plans, review observations/responses, manage corrective action timetables; lead pre-approval inspection readiness for contract manufacturers.
Qualifications:
- Bachelor’s degree in relevant Engineering, Life Science, or technical discipline, or equivalent experience.
- 7+ years total combined experience; at least 5 years Operations Quality Assurance and 3 years Operations, R&D, or Consulting.
- Comprehensive knowledge of combination products, medical devices, manufacturing processes; root cause investigations, CAPA, and statistics/data analytics (plus).
- Understanding of regulations/standards for combination products and medical devices; demonstrated quality leadership.
- Technical understanding of product development and/or practical design control experience.
- Risk management methodologies knowledge.
- Strong analytical/problem-solving skills; ability to challenge scientific arguments.
- Ability to work independently in global teams and at all organizational levels.