Job DescriptionThe Associate Director of Design Quality - 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.
Qualifications- Bachelor's Degree in relevant Life Science or other technical required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
- 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.
- A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
- Experience working the requirements for third party external manufacturing.
Additional InformationApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
