Director of Quality Operations

This innovative speciality biotech organisation is a leading science-based biopharmaceutical company based in the U.S that discovers, invents, develops, manufactures, and commercialises medicines for the treatment of serious medical conditions. This organisation commercialises medicines for eye diseases and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, asthma, and atopic dermatitis. Employing north of 4,000 staff globally with annual R&D spend of $1 billion, this organisation is consistently being voted one of the top innovative biotech organisations globally year on year.

The Position:

You will be responsible for the development and execution of the strategy and plan for the Industrial Operations and Product Supply (IOPS) quality function. You will also be responsible for providing direction to the functional area to ensure high-quality, safe and effective products that are compliant with global regulatory expectations. Additionally, you will direct the quality efforts of the applicable functional area in support of the compliance and business objectives and will ensure that adequate talent and other resources are available to meet the challenges of the organisation.

  • Implement a value-added quality system based on sound science and the application of the appropriate quality, regulatory and legal requirements.
  • Monitor the performance of the quality system using the appropriate metrics and demonstrate a commitment to continuous improvement.
  • Embed quality tools and risk management processes within the quality system.
  • Stay abreast of changing requirements/expectations and proactively address them with the quality system.
  • Use quality and risk management tools to make timely, science-based decisions to protect patient safety.
  • Implement appropriate solutions that address complex technical, legal and global regulatory standards.
  • Demonstrate confidence during difficult decision-making and influence internal and external business partners to ensure acceptable quality outcomes.
  • Lead as quality and compliance decision maker to ensure the safety and effectiveness of the products.
  • Represent as the face of IOPS quality and compliance to internal and external stakeholders, including regulatory agencies and corporate partners.
  • Translate the vision and business strategies of the Quality organisation into executable actions plans.
  • Ensure the Quality Strategy is transparent and the organisation is engaged in its execution.
  • Allocate resources based on the quality system priorities and corresponding business needs.

The Person

  • BS or higher in Engineering, Chemistry, Biology or related science/technical field; MS in science/technical field / QP Qualification would be an advantage.
  • Minimum of 15 years’ experience in a pharmaceutical/biotechnology manufacturing environment (biotech preferred) with 5+ years prior experience in a managerial capacity.
  • Prior experience with facility start-up, technology transfer, validation, Pre-Approval Inspections, and product launch activities is desired. Thorough knowledge of cGMPs and cGLPs; current knowledge and/or experience with QA systems such as change control, investigations (manufacturing / laboratory), deviations, CAPA, document management systems, etc.
  • Comprehensive knowledge and experience in CMC actions for investigational and marketed product submissions (IND, BLA, CBE, PSA) for FDA and equivalent (i.e. MAA, IMP, CTA/variations) submissions for Europe/Rest of World.

To learn more, apply online or contact Shane Browne on +353 1 632 1865.

Salary: On Application Location: Limerick