VP of Quality & Regulatory Affairs

Your Role

The Vice President of Quality Assurance will be responsible for the design, build, and implementation of the strategic framework of the Irvine Quality organization with a focus on driving effective and efficient business results, operational consistency, and cross-functional alignment. This position will lead the development and optimization of key processes, functional collaboration, transformational initiatives, and operational excellence through the Quality Unit. Under a matrix reporting structure, this role will report to the Global Quality Leader of the Drug Product Cluster and the Site Head of the Irvine Facility. This position is a crucial member of the site management team.

Essential Functions and responsibilities

• Ensure Siegfried's Quality Management System complies with all the regulatory expectations related to FDA, EU, ISO, and other agencies impacted by the business.
• Provide leadership in developing and maintaining the Quality System such that it will stand up to audits from regulatory agencies and customers, meeting Siegfried corporate system requirements.
• Work to simplify the operation and processes of the Quality function for efficiency and effectiveness.
• Drive corporate values, vision, goals, and objectives through collaboration with senior leaders building cross-functional networks to influence operational capabilities.
• Drive unification of global initiatives across the site and relevant functions to leverage synergies, improve interdependencies and promote operational excellence.
• Provide leadership and oversight in performance measurement, metrics, KPIs, and compliance across the business operations.
• Develop and maintain organizational design that drives high-performance capabilities and builds innovative solutions.
• Drive the definition and articulation of business objectives providing oversight and execution of strategic initiatives.
• Change management – Champion innovation with the design and execution of changes in operating models as the Quality Unit scale up and develop strategies that impact the work of the Quality team.
• Collaborate with stakeholders to ensure oversight of the corporate operating model, driving cost quality and resource decisions in line with growth and capability goals.
• Build and lead high-performance and collaborative teams by fostering effective coaching and mentoring to ensure strategies attract, develop and retain key talent.

Required Knowledge, Skills, and Abilities

• Extensive knowledge of Quality Operation and Regulatory Affairs
• Strong Understanding of the drug product process
• Collaborative team player and clear communicator who can influence effectively internally and externally.
• Creative and innovative leader with strong change management experience.
• Excellence organizational skills with project and capacity planning experience

Required Education and Experience

• Minimum 15 years of experience in a progressive Senior Quality Management role in the Biotech, Biopharma, or Pharmaceutical industries or ten years of relevant global quality operations.
• Bachelor’s degree, Master preferred.

Benefits

• Medical, Dental, Vision
• Voluntary Accident, Hospital, Pet
• 401K
• Generous Time Off Structure including PTO, Holidays, Sick & Personal