Director, Product Quality

AbbVie

Dublin, Ireland

Purpose

Responsible for overall quality of AbbVie products which may include small molecule pharmaceuticals and/or biologics, combination 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. Scope of responsibility can also include business processes required to support new product introduction, product monitoring or post-market quality systems. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.

Responsibilities

Lead a team of Quality professionals who are responsible for assigned products and/or business processes required for on-market product support (e.g. quality monitoring, supplier quality and/or post-marketing quality assurance);
Core team member or lead of strategic programs; including Brand Teams, Product Transfers, Global Strategic Sourcing, Post-Market commitments, Due Diligence, Site Selection, and Approvals and Continuous Improvement;
Develop and implement a global Product Quality Assurance strategy to support pharmaceutical, biologics, and combination products manufactured at AbbVie plants or third party manufacturing (TPM) facilities. Ensures alignment of Quality and Technical Agreements with the legal contracts that the commitments of the quality and technical agreements are being fulfilled;
Support development of the legal supply agreements, contracts and letters of intent to ensure the appropriate quality, compliance, and regulatory aspects are met for the products and services covered and manage the organizations actions with the legal boundaries of these documents. Approves negotiated quality and technical agreement as a representative of AbbVie;
Ensures business objectives are met as regards to on time delivery of product and to budget while assuring compliance to local and divisional land corporate policies where appropriate. Liaise with Research and Development, supply chain, medical safety evaluation and Commercial functions to ensure all market place issues are recognized by operations management;
Key decision maker on product quality and regulatory conformance issues; reviews and approves plant Quality Assurance performance reports and financial plans. Directs the Quality Assurance initiatives for global sourcing projects;
Reviews and approves budgets. Interfaces with internal audit teams to develop audit plans, reviews audit observations and responses and maintains a corrective action timetable;
Monitors manufacturing operations for conformance with established procedures and requirements of corporate and governmental good manufacturing practices;
Develops and executes global strategies related to product complaints management and stability assessment for all products globally.

Qualifications

Graduate Degree Life Science or other technical discipline required;
15+ years of total combined relevant experience. At least 2 years Plant experience; at least 5 years in Operations, Research and Development or Technical experience. Plant operational leadership experience preferred;
Expert knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies;
Capable of understanding and overcoming differing cultural and language obstacles to providing solutions that satisfy both functional and local objectives;
Capable of analyzing data facts and informed opinion to direct the developments of effective action plans as well as the ability to problem solve;
Credible working relationship with plants.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job