Executive Director, Quality Site Head Stein

Role Purpose

The Quality Site Head is a key member of the site leadership team and is responsible for leading, developing, and continuously improving all quality‑related activities across the site. As the organization expands its Drug Product (DP) manufacturing capabilities and scales operations, this role will provide strategic and operational quality leadership to ensure the highest standards of product quality, patient safety, regulatory compliance, and business performance.

The Quality Site Head will drive the site’s quality culture, strengthen organizational capabilities, and ensure alignment with global quality strategies while supporting the successful growth of a world‑class Contract Development and Manufacturing Organization (CDMO). This role will play a critical part in preparing the site for future expansion, regulatory inspections, customer audits, and increasing manufacturing complexity.

• Quality Leadership & Site Governance – Serve as the senior quality leader for the site and a trusted advisor to the Site Head and leadership team. Define and execute the site’s quality strategy in alignment with global quality objectives and business priorities. Lead all quality functions, including quality assurance, quality control, compliance, validation, and quality systems. Foster a proactive quality culture that promotes accountability, continuous improvement, and patient‑centric decision‑making.
  
  Build and develop a high‑performing quality organization capable of supporting significant site growth and increasing operational complexity.
• Drug Product Quality Leadership – Lead and strengthen all quality activities related to drug product manufacturing, packaging, testing, release, and lifecycle management. Ensure compliance with current GxP requirements and FDA, EMA, Swiss medic, and other applicable global regulatory standards. Provide expert guidance on quality aspects of aseptic processing, sterile manufacturing, biologics, and advanced drug product technologies, as applicable. Partner closely with manufacturing, MSAT, engineering, supply chain, and technical services to ensure robust quality oversight throughout the product lifecycle.
  
  Spend time on the shop floor in Gemba’s acting as a coach.
• Organizational Growth & Capability Development – Develop the quality organization to support the site’s growth from approximately 500 to 1,000 employees. Assess organizational capabilities and identify competency gaps across quality functions. Implement talent development, succession planning, coaching, and training programs to build future leadership capabilities. Attract, retain, and develop top‑quality talent while fostering a culture of engagement, collaboration, and innovation. Work shoulder to shoulder with the site head championing quality culture.
• Regulatory Compliance, Audits & Inspections – Ensure inspection readiness at all times and maintain a robust quality management system. Lead and oversee regulatory inspections, customer audits, and corporate quality assessments. Act as the primary quality representative during interactions with regulatory authorities and key customers. Ensure timely and effective investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
• Quality Systems & Continuous Improvement – Drive continuous improvement initiatives across all quality processes and systems. Promote the use of modern quality methodologies and digital quality tools, including Six Sigma, Lean principles, FMEA, SPC, and advanced analytics. Ensure effective management of deviations, change controls, complaints, CAPAs, risk assessments, and product quality reviews. Establish and monitor meaningful quality performance indicators to drive operational excellence and business performance.
• Risk Management & Decision Making – Apply science‑ and risk‑based approaches to quality oversight and decision‑making. Anticipate and proactively mitigate quality and compliance risks associated with site growth, new technologies, and customer programs. Ensure effective escalation and resolution of critical quality issues while balancing patient safety,…