Senior Director, Site Quality

Senior Director, Site Quality (PR/591508) Wisconsin, USA

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We’re partnering with a growing biologics manufacturing organization to hire a Senior Director, Quality to lead and scale the site Quality organization at a large, complex manufacturing campus.

This is a high‑impact leadership role for someone who wants to grow something meaningful — building, developing, and elevating a large Quality team today, with a clear path to expanded scope and senior leadership opportunities across the broader organization over time.

What you’ll be responsible for:

• Lead the site Quality organization and serve as a core member of the site leadership team
• Drive a strong quality and patient‑first culture across manufacturing and support functions
• Own and continuously improve the site Quality Management System (QMS)
• Provide leadership and oversight to Quality leaders and teams supporting biologics manufacturing
• Ensure products are manufactured, tested, released, and supplied in full cGMP compliance
• Partner closely with Operations, Process Development, Program Management, and the Site Head
• Oversee investigation, deviation, and CAPA execution for critical quality events
• Establish and track quality metrics, escalation processes, and remediation plans
• Act as senior quality contact for customer interactions and regulatory inspections
• Interpret and defend regulatory positions with global health authorities as needed
• Build a strong talent pipeline through hiring, development, and succession planning
• Manage quality budgets and resource planning aligned with business needs
• Bachelor’s or Master’s degree in a scientific or related discipline
• 10+ years of biologics manufacturing experience in a regulated environment
• Proven experience leading large, multi‑layered Quality organizations
• Strong background in global cGMP regulations (FDA, EMA, and other Tier 1 agencies)
• Experience with drug substance manufacturing; drug product experience a plus
• Demonstrated ability to partner with senior leadership and manage complex customer discussions
• Track record of driving measurable improvements in quality systems, performance, and talent

Why this role:

• Senior site‑level leadership role with broad scope and visibility
• Opportunity to build, grow, and mature a large Quality organization
• Clear runway for career progression into more senior enterprise‑level Quality leadership
• Direct impact on patient outcomes and long‑term site success