Associate Director, Design Quality – Design Lifecycle Management

About the role

The Associate Director of Design Quality â Design Lifecycle Management oversees the Design Lifecycle Management team responsible for combination products and medical devices. This leadership role manages the seamless design transfer of new product designs into manufacturing, directs design change management for products already on the market, and executes assurance of supply projects. The team also drives initiatives supporting geographic expansion and other lifecycle management activities. The role ensures all assigned products, including on-body delivery systems, pre-filled syringes, auto-injectors, infusion pumps, tubing, pump accessories, and aesthetics medical devices such as breast implants, fillers, and body contouring devices, meet business objectives and comply with local, divisional, corporate, and global regulatory standards.

Responsibilities

• Lead, mentor, and develop a team of quality professionals and subject matter experts (SMEs) responsible for design controls and quality management during design transfer of new products and ongoing lifecycle projects for on-market products.
• Oversee execution and fulfillment of quality requirements for lifecycle management of on-market products, including change control for on-market devices, execution of assurance of supply projects and geographic expansions.
• Facilitate effective Change Control activities, including design change impact assessments and approval of relevant changes.
• Develop design control strategies along with the cross-functional team to verify, validate, and implement on-market design changes.
• Develop, implement, and continually improve global quality assurance strategies in partnership with Regulatory Affairs, Marketing, Operations, Product Development, and other cross-functional teams.
• Make key strategic decisions regarding product quality, compliance, and regulatory matters, escalating significant risks to AbbVie leadership as needed.
• Collect, validate, and analyze quality metrics, present compliance status and actionable insights for local and global initiatives during management reviews.
• Partner with cross-functional team and third-party manufacturers to maintain consistent quality standards and minimize compliance risks.
• Support and drive continuous improvement by identifying gaps or improvement opportunities within Design History Files, risk management, processes, and policies and tracking actions to closure.
• Foster a culture of proactive quality, cross-functional collaboration, and ongoing process improvement.

Requirements

• Bachelor's Degree in relevant Life Science or other technical field required. Graduate degree desired.
• Total combined years of experience: Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred.
• Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
• Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem-solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members, and individuals.
• Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.

Qualifications

• Experience working the requirements for third party external manufacturing.

Skills

• Leadership and mentoring skills.
• Strategic thinking and decision-making abilities.
• Change management and project management expertise.
• Collaborative and cross-functional teamwork.
• Quality assurance and compliance oversight.
• Technical and regulatory knowledge.

Benefits

AbbVie offers a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and a 401(k) plan to eligible employees. This role is eligible to participate in AbbVie's long-term incentive programs.

Pay

$141,500 - $268,500 USD

Schedule

Hybrid