VP of Quality & Regulatory Affairs

About the Role

As the Vice President of Quality Assurance, you will design, build, and implement the strategic framework of the Irvine Quality organization, focusing on driving effective and efficient business results, operational consistency, and cross-functional alignment. This role 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 under a matrix structure, you will be a crucial member of the site management team.

Responsibilities

• Ensure Siegfried's Quality Management System complies with all regulatory expectations related to FDA, EU, ISO, and other relevant agencies.
• Provide leadership in developing and maintaining the Quality System to withstand audits from regulatory agencies and customers, meeting Siegfried corporate system requirements.
• 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.
• Unify 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 an organizational design that drives high-performance capabilities and builds innovative solutions.
• Define and articulate business objectives, providing oversight and execution of strategic initiatives.
• Champion innovation and change management in operating models as the Quality Unit scales, developing strategies that impact the Quality team.
• Collaborate with stakeholders to ensure oversight of the corporate operating model, driving cost, quality, and resource decisions aligned with growth and capability goals.
• Build and lead high-performance, collaborative teams by fostering effective coaching and mentoring to attract, develop, and retain key talent.

Requirements

• Extensive knowledge of Quality Operations 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.
• Excellent organizational skills with project and capacity planning experience.

Qualifications

• 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 experience.
• Bachelor’s degree required; Master’s degree preferred.

Pay

Target salary range: $215,000–$245,000 plus an annual bonus based on individual and site performance metrics. Individual compensation packages are based on factors such as skill set, experience, and qualifications.

Benefits

• Medical, Dental, and Vision insurance.
• Life insurance and voluntary accident, hospital, and pet insurance.
• 401K retirement plan.
• Generous time off structure, including PTO, holidays, sick leave, and personal days.

About Siegfried

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents, employing over 4,200 highly skilled professionals. As a fully integrated CDMO, Siegfried develops and manufactures APIs and finished dosage forms under one roof, making it a trusted partner in the pharmaceutical industry.