Director of Quality Operations

This innovative biotech organisation is known for its scientific and operational excellence. A leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercialises medicines for the treatment of serious medical conditions. With products marketed covering medicines for eye diseases, colorectal cancer, and a rare inflammatory condition, and product candidates in development for other areas of high unmet medical need, including oncology, rheumatoid arthritis, and atopic dermatitis, this organisation is widely regarded as one of the most innovative biotech organisations globally.

The Position:

  • 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 with the quality system.
  • Stay abreast of changing requirements/expectations and proactively address 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 action 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.
  • Establish high standards for performance management and accountability to achieve quality and organisational objectives.
  • Attract, retain and proactively develop a pipeline of key talent through coaching, training, experience development and internal/external recruitment.
  • Identify business-critical positions and establish robust succession planning strategies.

The Candidate:

  • 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.

To learn more apply on line or call Shane Browne on +353 1 6321865

Salary: On Application Location: Limerick