VP of Quality & Regulatory Affairs

Siegfried•Irvine, CA

3d•$215,000 - $245,000•Onsite

About The Position

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.

Requirements

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
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.

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.
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.