Senior Director, Quality

Catalent•Harmans, MD

8d•$250,000 - $350,000•Onsite

About The Position

Catalent’s Baltimore facility is a leading center for biologics development and manufacturing, offering state-of-the-art capabilities in clinical and commercial supply. The site supports a wide range of services, including process development, drug substance manufacturing, and aseptic fill/finish for biologics and advanced therapies. With a strong focus on innovation and quality, the Baltimore location plays a key role in delivering life-changing treatments to patients worldwide. Team members here work in a collaborative environment that values expertise, precision, and continuous improvement, making it an exciting place to contribute to cutting-edge biopharmaceutical solutions. Reporting directly to the VP of Quality - Biologics and with strong working relationship with the VP General Manager Maryland and the Site Leadership Team (SLT), this key leadership positions is accountable for ensuring the successful delivery of quality and regulatory strategy and operational performance for the Maryland campus. The position is responsible for establishing and staffing the Quality Unit to ensure the organizational structure, talent, bench strength, and staffing is effective in delivering the expected outcomes, in the right way, for SQDC and strategic growth plans. Working with and leveraging the entire Global Catalent network, the position executes growth strategies, leading quality-related aspects of the transition into commercial manufacturing and delivers on the expected quality culture for the manufacturing sites. Ultimate responsibility for the quality, compliance and operational performance of the site(s) rests with the Sr. Director of Quality. This includes, but is not limited to, working through regulatory inspections and responses and leading others through critical deviations and outcomes including working with customers on the disposition of product and/or other regulatory actions. Finally, the Sr. Director of Quality is responsible for ensuring the business aspects, including the budgeting and sourcing to ensure the on-time release and costs of the Quality Unit, are in-line with the business requirements.

Requirements

Bachelor's or Master's Degree in Science, Pharmacy, or related discipline.
7+ years’ experience in Biologics, Vaccines, Gene Therapy or large-scale pharmaceutical environment
Experience with sterile drug product manufacturing and drug substance manufacturing.
Knowledge of global current Good Manufacturing Practice regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.
Demonstrated business acumen and ability to manage challenging client discussions.
Ability to operate effectively in an environment with high levels of ambiguity.
Visionary leadership with the ability to identify new trends in quality and regulatory landscapes.
Proven experience in driving quality performance improvements, talent development, process improvements, and standardization.
Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‑sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience.

Nice To Haves

Master of Business Administration or PhD is an advantage.
Experience in managing a multi-site quality function in Biologics, Vaccines, or Gene Therapy is preferred (minimum of 100+ quality employees overseen)
Continuous improvement mindset is critical.

Responsibilities

Partner effectively with other functional leaders (Product Development, Operations, etc.) and Site General Manager to develop and maintain a meaningful and robust Quality and Patient First and Quality culture across all aspects of the business.
Champion, through clear and visible advocacy, Catalent's Quality Management System (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization.
Responsibility for ensuring the site Quality leadership teams (150-200 HC) is staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels across the sites, and creating a strong succession pipeline for key leadership roles.
Define activity-based cost models and establish and execute a budget that is in-line with the requirements of the business to deliver on the testing, release and QMS commensurate with the needs of the business to operate effectively and efficiently.
Ensure appropriate metrics and reporting/escalation processes are in place and being utilized to drive and improve required operational execution and performance levels and drive appropriate corrective actions planning when needed.
Drive actions and remediation as required to meet the quality performance and standards set for the site.
Drive execution and outcomes on critical deviations provide clear direction and oversight including the review and approval of the deviations as well as effective CAPA plans
Deliver on the annual goals and objectives established with and approved through the business unit.
Demonstrate strong business and fiduciary responsibility in the management of their budgets, and broader business decision-making, acting as both functional and business leaders.
Development of strong customer relationships, partnering with other Catalent leaders to establish outstanding performance and customer impact that acts as a true competitive differentiator.
Evaluate existing processes and identifies improvement to enhance efficiency, consistency, and competitiveness within the market.
Other duties as assigned.