Senior Manager, Product Quality Neurotoxin

Senior Manager, Product Quality Neurotoxin

AbbVie

Cork, Ireland

We are now recruiting a Senior Manager, Product Quality Neurotoxin for our diverse Team. 

Reporting to the Product Quality Director, you will be responsible for quality of assigned products and near commercial Neurotoxin Pipeline 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 under your remit include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. You will act as the primary quality representative for the global supply chain pertaining to manufacturing business relationships and build and maintain relationships with IME Operations, Supplier Quality Management, Commercial QA, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on strategic initiatives.

Are you intrigued? Do you want to learn more?

A snapshot of your key responsibilities would be:

• Direct cross-functional team member to achieve on-time quality deliverables, high customer value, and high quality product to meet patient demands. Ensures delivery of quality elements needed to facilitate lifecycle management that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing.
• Product Quality contact for Post Marketing Quality Assurance with end-to-end understanding and management of customer complaints across the various nodes within AbbVie. Routine complaint trending and analysis.
• Product Quality Assurance contact for Global Change control system, including Quality Assessment of changes, and oversight of all global changes. Chair of the gCRB.
• Develops Global Product Quality Assurance strategies and implements agreed strategies to support relevant products produced at AbbVie plants.
• Reviews, approves and opens necessary Quality System Management records in a timely manner to maintain a high level of product compliance. Supports the management of exception documents and CAPA where relevant.
• Makes key decisions on product quality, compliance and regulatory conformance issues 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 same agreements are being fulfilled.
• Core team member or lead of strategic programs; including Brand Teams, New Product
• Introductions, Product Transfers, Global Strategic Initiatives.
• Influences the decision making process to ensure quality requirements are included when improvement initiatives take place.

Qualifications

Education & Experience 

• Bachelor’s Degree in relevant Life Science or other Technical area required.
• Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues.
• Minimum of 5+ 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 pharmaceuticals.