Associate Director, Design Quality – Design Lifecycle Management
AbbVie
June 25, 2026
Remote friendly (North Chicago, IL)
United States
$141,500 - $268,500 USD yearly
Operations
Responsibilities:
- Lead and develop a team of quality professionals/SMEs responsible for design controls and quality management during design transfer of new products and lifecycle projects for on-market products.
- Oversee execution and fulfillment of quality requirements for lifecycle management of on-market products, including change control, assurance of supply projects, and geographic expansions.
- Facilitate Change Control, including design change impact assessments and approval of relevant changes.
- Develop design control strategies with cross-functional teams to verify, validate, and implement on-market design changes.
- Develop, implement, and continuously improve global quality assurance strategies with Regulatory Affairs, Marketing, Operations, Product Development, and other cross-functional teams.
- Make strategic decisions on product quality, compliance, and regulatory matters; escalate significant risks as needed.
- Collect, validate, and analyze quality metrics; present compliance status and actionable insights during management reviews.
- Partner with cross-functional teams and third-party manufacturers to maintain quality standards and minimize compliance risk.
- Drive continuous improvement by identifying gaps in Design History Files, risk management, processes, and policies; track actions to closure.
- Foster proactive quality, cross-functional collaboration, and ongoing process improvement.
Qualifications:
- Bachelor’s Degree in relevant Life Science or other technical field (graduate degree desired); technical/analytical background for problem resolution.
- 10+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting; required regulatory inspection experience with direct interaction with inspectors (5+ years direct plant experience preferred).
- Knowledge of biological/pharmaceutical technologies (e.g., sterile, liquid/ointments, devices, tablets/caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release, coating solutions, APIs).
- Strong analytical/problem-solving skills, urgency, interpersonal skills, ability to manage multiple complex tasks; leadership and teamwork.
- Strong background in quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation.
- Experience working with third-party external manufacturing requirements.
Benefits (as stated): Paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.
- Lead and develop a team of quality professionals/SMEs responsible for design controls and quality management during design transfer of new products and lifecycle projects for on-market products.
- Oversee execution and fulfillment of quality requirements for lifecycle management of on-market products, including change control, assurance of supply projects, and geographic expansions.
- Facilitate Change Control, including design change impact assessments and approval of relevant changes.
- Develop design control strategies with cross-functional teams to verify, validate, and implement on-market design changes.
- Develop, implement, and continuously improve global quality assurance strategies with Regulatory Affairs, Marketing, Operations, Product Development, and other cross-functional teams.
- Make strategic decisions on product quality, compliance, and regulatory matters; escalate significant risks as needed.
- Collect, validate, and analyze quality metrics; present compliance status and actionable insights during management reviews.
- Partner with cross-functional teams and third-party manufacturers to maintain quality standards and minimize compliance risk.
- Drive continuous improvement by identifying gaps in Design History Files, risk management, processes, and policies; track actions to closure.
- Foster proactive quality, cross-functional collaboration, and ongoing process improvement.
Qualifications:
- Bachelor’s Degree in relevant Life Science or other technical field (graduate degree desired); technical/analytical background for problem resolution.
- 10+ years in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting; required regulatory inspection experience with direct interaction with inspectors (5+ years direct plant experience preferred).
- Knowledge of biological/pharmaceutical technologies (e.g., sterile, liquid/ointments, devices, tablets/caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release, coating solutions, APIs).
- Strong analytical/problem-solving skills, urgency, interpersonal skills, ability to manage multiple complex tasks; leadership and teamwork.
- Strong background in quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation.
- Experience working with third-party external manufacturing requirements.
Benefits (as stated): Paid time off; medical/dental/vision insurance; 401(k); eligible for long-term incentive programs.