Senior Director, Site Quality
Senior Director, Site Quality
Location: Wisconsin (100% onsite)
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
Background requirements:
- 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
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