Allergan Aesthetics, an AbbVie Company · 3 hours ago
Design Quality - Late Stage Development Manager
North Chicago, IL
Full-time
Onsite
Mid, Senior Level
$106K/yr - $202K/yr
7+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions. They are seeking a Design Quality - Late Stage Development Manager to ensure the quality of new product introduction combination products and medical devices while ensuring compliance with regulations and corporate policies.
BeautyManufacturingPharmaceuticalWellness
Responsibilities
Serves as the primary quality lead for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization
Assure proper integration and support of device regulations, drug regulations and as appropriate, biologics regulations. Responsible for compliance with company policies and procedures
Perform design control activities: Mentor/lead product team members through the design process providing guidance to assure optimal approach. Work closely with research organization to ensure potential product issues are identified and addressed in the design. Assure robust product vs. customer requirements. Participate in design reviews. Ensure interfaces to drug development where appropriate
Ensure design control documentation (Traceability/Linkages) & design change control requirements are met. Assess the impact of a change on the safety, efficacy of the combination product/device. Analyze and justify the impact on cumulative changes
Identify gaps in existing processes as well as the need for new processes. Lead cross-functional teams for solution development and implementation
Guide project development as a team member in global and local product development teams for Combination Products to proactively and appropriately address quality-related issues. Advise internal business partners with regard to medical device/combination product regulations
Support the preparation of regulatory inspections and internal audits and represent QA in inspections and audits as SME
Participates in the development of global Product Quality Assurance strategy to support device and combination products produced at AbbVie plants as well as contract manufacturing and supplier facilities. Implements agreed strategy
Participates on New Product teams to bring combination products and medical devices through the Design Control process to deliver on-time product launches. Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and international plants for further packaging and/or testing
Makes recommendations for key decisions on product quality, compliance and regulatory conformance issues for sterile and unsterile devices and elevates medium and high-risk events to AbbVie management
Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not
Maintains relationships and open communication with suppliers, contract manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns
Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities
Interfaces with AbbVie's audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to contract manufacturers to ensure regulatory approvals are obtained, with no delays to market entries
Qualification
Required
Bachelor's Degree in relevant Engineering, Life Science or other technical discipline or equivalent job experience required
7+ years of total combined experience. At least 5 years in Operations Quality Assurance, 3 years in Operations, Research and Development or Consulting
Knowledge and a comprehensive understanding of combination products, medical devices and manufacturing processes. Experience with root cause investigations, CAPA, statistics and data analytics is a plus
Understanding of regulations and standards affecting combination products and medical devices required. Must have leadership skills and have been seen to take a position on Quality issues and standards and must be capable of clearly and logically justifying such positions
Sound technical understanding of product development (e.g. approaches for definition of requirements and specification setting for verification and validation) and/or practical experience in design control
Well-versed in risk management methodologies and their application
Able to take the initiative to identify and implement new approaches to resolve problems, able to challenge scientific arguments - strong analytical approach to identify problem areas and effective solutions
Work independently and in a global team environment, and with all levels of personnel within the organization
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, members and individuals
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Company
Allergan Aesthetics, an AbbVie Company
At Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products.
1001-5000 employees
H1B Sponsorship
Allergan Aesthetics, an AbbVie Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2023 (1)
2022 (16)
2021 (14)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Nicole Mowad-Nassar
Senior Vice President, AbbVie and President, Global Allergan Aesthetics
Recent News
2025-12-04
Company data provided by crunchbase