Aseptic Product Quality Manager

About Abb Vie

Abb Vie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, and neuroscience—and products and services in our Allergan Aesthetics portfolio. For more information, visit  Follow us on Linked In, Facebook, Instagram, X, and You Tube.

• The Aseptic Product Quality Manager serves as a quality SME for aseptic manufacturing within the External Product Quality Assurance Eye Care Global Team.
• Supports aseptic events within the Eye Care Quality Assurance Third‑Party Manufacturer (TPM) team by providing hands‑on assessments and investigation support.
• Drives implementation of aseptic best practices at TPMs based on Abb Vie standards and technological advancements.
• Promotes continuous improvements that proactively identify, quantify, prioritize, and mitigate aseptic risks.
• Establishes collaborative relationships with Abb Vie internal sites, the aseptic global team, and cross‑functional teams.
• Acts as the primary quality lead, overseeing project activities and team members (internal and external) to achieve on‑time quality deliverables and profitable results.
• Provides support for final quality release of manufactured product lots for products or product lines prepared by third‑party manufacturers.
• Recommends key decisions on product quality, compliance, and regulatory conformance for sterile, biological, liquid, solids, and device products; escalates medium and high‑risk events to Abb Vie management.
• Ensures alignment of Quality and Technical Agreements with legal contracts and facilitates resolution when commitments are not met.
• Maintains communication with TPMs, Abb Vie plants, affiliates, and other functional groups to identify potential projects, issues, and quality needs.
• Negotiates with external quality organizations to maintain consistent quality levels and expectations while balancing operating costs.
• Prioritizes programs and problem‑solving initiatives considering impact on timelines and resources.
• Interfaces with the QA audit team to develop audit plans, due diligence plans, and inspection readiness plans; reviews audit observations and corrective action timetables.
• Supports quality audits, initial site approvals, and due diligence activities; leads and manages pre‑approval inspection readiness for third‑party manufacturers.
• Contributes to QA elements needed for new product launches, including TPMs that provide products directly to distribution centers or Abb Vie plants for packaging/testing.
• Coordinates follow‑up on compliant trend investigations for non‑medical and medical adverse events and supports the management of exception documents and corrective/preventive actions.
• Completes management reviews with assigned TPMs to identify and address quality, operational, and organizational issues.
• Obtains and reviews summaries of Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) to ensure accuracy, completeness, and trend identification.
• Role can be worked from any Abb Vie site globally.

• Bachelor’s Degree in a relevant Life Science or technical discipline, or equivalent job experience.
• 7+ years of total combined experience, including at least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management and 3 years in Operations, R&D, or Consulting.
• Comprehensive knowledge of aseptic manufacturing and biological/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).
• Ability to operate in a high‑urgency environment with strong analytical and problem‑solving skills, positive interpersonal skills, and the capacity to manage multiple complex tasks concurrently.
• Demonstrated leadership, team‑member, and individual contributor skills.

• The compensation range described below is the range of possible base pay…