Allergan Aesthetics, an AbbVie Company · 1 day ago
Senior Project Manager, QA
North Chicago, IL
Full-time
Onsite
Senior Level, Lead/Staff
$121K/yr - $230K/yr
8+ years expAbbVie is a company dedicated to discovering and delivering innovative medicines and solutions for serious health issues. The Senior Project Manager, QA is responsible for ensuring the quality of assigned products, leading quality assurance strategies, and managing relationships with third-party manufacturers to meet business objectives and regulatory compliance.
BeautyManufacturingPharmaceuticalWellness
Responsibilities
Maintains the primary quality lead with management oversight for project Quality 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, risk management, and compliance aspects of product transfers and organization optimization
Leads the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy
Makes key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products 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
Establishes and maintains relationships and open communication with Third Party 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. Primary quality contact with Supply Chain and R&D for new products to be manufactured at TPMs. Acts as a resource for TPMs to evalua
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 Quality Assurance 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 the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries
Manages 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. Drives implementation of the Product Transfer Process from R&D to AbbVie sites
Supports the management of exception documents and Corrective and Preventive Actions. Coordinates input from technical groups (R&D, S&T, Site Tech Ops) to determine root cause and implement appropriate actions
Develops product quality transfer process monitoring metrics. Manages small teams of quality professionals as required and maintains departmental spend within budget
Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph. Eur. Documents. Work with AbbVie Affiliates and Regulatory to prepare submissions and participate on emergency response team for all incoming submission deficiencies and questions
Qualification
Required
Bachelor's Degree in relevant Life Science, Engineering, or other technical discipline required
Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues
Minimum 8+ years of total combined years of experience
At least 3 years in Quality Assurance Operations Management
5+ years in any of the following areas; Operations, Research and Development, Regulatory or Consulting
Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required
Experience with FDA and other regulatory agency interactions and inspections is required
Familiarity with the requirements for third party external manufacturing
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
Preferred
Direct Manufacturing Plant experience in a Pharmaceutical setting is preferred
Knowledge and a comprehensive understanding/expertise 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)
Benefits
Paid time off (vacation, holidays, sick)
Medical/dental/vision insurance
401(k)
Short-term incentive programs
Long-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