Senior Site Quality Director, Biologics

Catalent Pharma Solutions; United States; On-site; USD 200,000 - 260,000; Full time

Benefits offered by this job

401K match

Paid Time Off accrual

Medical, dental and vision benefits

Job summary

Catalent Biologics is seeking a Senior Director, Site Head of Quality to lead the Quality organization onsite at Madison. You will champion the Patient First culture, drive the QMS, and ensure GMP conformance across the site, reporting to the Site General Manager with accountability for 100-200 HC quality leaders.

You will oversee budget, metrics, CAPA, deviations, and regulatory readiness, while building a robust talent pipeline and strong customer relationships.

Qualifications

• Bachelor's or Master's Degree in science, pharmacy or related discipline is required.
• Extensive experience (10+ yrs) in biologics is a requirement.
• Experience with drug substance manufacturing is required.
• Knowledge of global cGMP regulations including FDA, EMA, ANVISA.

Responsibilities

• Lead the site Quality organization and ensure conformance with QMS.
• Drive CAPA, deviations, and quality improvements across the site.
• Develop budgets and cost models aligned with testing, release, and QMS needs.
• Maintain customer relationships and ensure readiness for regulatory reviews.

Skills

Leadership

Regulatory knowledge

Quality management

Biologics experience

Education

Bachelor's degree in science

Master's degree

Job description

Catalent Biologics is seeking a Senior Director, Site Head of Quality to lead the Quality organization onsite at Madison. You will champion the Patient First culture, drive the QMS, and ensure GMP conformance across the site, reporting to the Site General Manager with accountability for 100-200 HC quality leaders.

You will oversee budget, metrics, CAPA, deviations, and regulatory readiness, while building a robust talent pipeline and strong customer relationships.