VP of Quality & Regulatory Affairs

Role Overview

"Expect to grow", personally and professionally:
At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long‑term opportunities to grow and make an impact.

The Vice President of Quality Assurance will be responsible for the design, build, and implementation of the strategic framework of the Irvine Quality organization, focusing on driving effective and efficient business results, operational consistency, and cross‑functional alignment. This position leads the development and optimization of key processes, functional collaboration, transformational initiatives, and operational excellence through the Quality Unit, reporting to the Global Quality Leader of the Drug Product Cluster and the Site Head of the Irvine Facility.

• Lead the design, build and implementation of the strategic framework of the Irvine Quality organization.
• Drive the development and optimization of key processes, functional collaboration, transformational initiatives, and operational excellence through the Quality Unit.
• Ensure Siegfried’s Quality Management System complies with regulatory expectations related to FDA, EU, ISO, and other agencies.
• Provide leadership in developing and maintaining the Quality System to stand up to audits from regulatory agencies and customers, meeting 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 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 scales up, impacting 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 attract, develop, and retain key talent.

• Extensive knowledge of Quality Operations and Regulatory Affairs.
• Strong understanding of the drug product process.
• Collaborative team player and clear communicator able to influence effectively internally and externally.
• Creative and innovative leader with strong change management experience.
• Excellent organizational skills with project and capacity planning experience.

Minimum 15 years of progressive Senior Quality Management experience in the biotech, biopharma, or pharmaceutical industries, or ten years of relevant global quality operations. Bachelor’s degree required;
Master’s preferred.

Target Salary Range: $,000 + annual bonus based on individual and site performance metrics. Compensation packages are based on factors unique to each candidate, including skill set, experience, qualifications and other job‑related reasons.

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