Senior Director, Site Head of Quality

Catalent•Madison, WI

13h•Onsite

About The Position

The Senior Director of Quality is a member of the site leadership team and leads in a manner that promotes a Patient First culture throughout the organization. The role is directly responsible for the Site Quality Directors and managers under their responsibility and drives consistent “One Catalent” quality standards across the organization. It ensures that the systems needed to produce products in conformance with good manufacturing practices and standards are implemented and followed. The Senior Director also establishes and maintains positive customer relationships and provides direction to customers and the organization to address critical performance issues. The position partners with functional leaders and the Site General Manager to establish a robust Patient First and Quality culture, champions Catalent’s Quality Management System, and ensures strong technical and leadership capability across the Quality organization. It oversees staffing, performance, and succession planning for site Quality teams of 100–200 headcount; establishes activity-based cost models and budgets; maintains metrics and escalation processes; drives remediation and quality improvements; and provides direction and oversight for critical deviations and CAPA plans. This is a 100% onsite role. Catalent describes its Biologics business as a small, fast-growing business backed by a private company, with opportunities for career development as it grows. The work supports products intended to treat a range of conditions, including COVID-19, cancer, autoimmune and blood disorders, HIV, diabetes, heart and lung diseases, and Alzheimer’s.

Requirements

Bachelor’s or master’s degree in science, pharmacy, or a related discipline.
At least 10 years of experience in biologics.
Experience with drug substance manufacturing.
Demonstrated business acumen and ability to manage difficult discussions with clients.
Demonstrated success leading Quality organizations, preferably in a matrix-style organization.
Knowledge of global cGMP regulations, including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.
Proven experience driving substantial improvements in quality performance across initiatives such as talent development and recruitment, process improvements, and elimination of exceptions and SOP standardization.
Ability to provide reliable, defensible interpretations of regulatory guidance to customers and defend those positions to regulatory agencies.

Nice To Haves

Experience with drug product manufacturing.
Demonstrable leadership experience at Catalent, including participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW, may be considered in place of external experience.

Responsibilities

Partner with functional leaders, including Process Development, Operations, and Program Management, and the Site General Manager to develop and maintain a Patient First and Quality culture.
Champion Catalent’s Quality Management System and ensure strong technical and leadership capability throughout the Quality organization.
Ensure site Quality teams of 100–200 headcount are staffed with high-caliber leaders and professionals; promote effective performance and build succession pipelines for key leadership roles.
Define activity-based cost models and establish and execute a budget aligned with business needs for testing, release, and the Quality Management System.
Ensure appropriate metrics and reporting and escalation processes are in place and used to improve operational execution and drive corrective actions.
Drive actions and remediation needed to meet site quality performance and standards.
Direct and oversee execution and outcomes for critical deviations, including review and approval of critical deviations and effective CAPA plans.
Establish and maintain positive customer relationships and provide direction to customers and the organization on critical performance issues.
Perform other duties as assigned.