Associate Director, Product Quality

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Responsible for quality of assigned Biological, and/or Gene Therapy products to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by Abb Vie plants or by third‑party manufacturers, in Licensing relationships, or Co‑Marketing relationships.

Acts as the primary quality representative for the global supply chain pertaining to external manufacturing business relationships and builds and maintains relationships with TPM Operations, Supplier Quality Management, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International Abb Vie Plants and Affiliates, Regulatory Affairs, R&D, and PDS&T to ensure alignment.

• Support Quality for product transfer activities and direct cross‑functional team members to achieve on‑time quality deliverables, high customer value, and profitable results. Ensures delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to Abb Vie domestic and International plants for further packaging and/or testing.
• Supports control strategy QA oversight for selected Biological, Neurotoxin and Gene Therapy products with continuous improvement and efficiencies in mind. Will collaborate with strategic partners to ensure right first time goals are achieved.
• Primary Quality contact between third party manufacturers, R&D and Abb Vie Operations in support of commercial operations, New Product Introductions and product transfers. Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph. Eur. Documents. Lead QA contact with Abb Vie Affiliates and Regulatory to prepare submissions.
• Makes key decisions on product quality, compliance and regulatory conformance issues for sterile biological products and elevates medium and high risk events to Abb Vie management. Leads the collection, verification and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local / global project implementation.
• Leads product quality team to support development of the legal supply agreements, contractors or letters of intent to ensure that the appropriate quality, compliance and regulatory aspects are met for the products and services covered and manage the organisation’s actions within the legal boundaries of these documents. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled.
• Establishes and maintains relationships and open communication with Third Party Manufacturers, Abb Vie 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. Supports the management of exception documents and CAPA.
• 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…