Senior Director, Quality

Catalent; Harmans (MD); On-site; USD 250,000 - 350,000; Full time

Benefits offered by this job

Medical benefits day one

Tuition reimbursement

Performance bonuses

Job summary

Catalent's Baltimore facility in Harmans, MD seeks a Senior Director of Quality to lead the Quality Unit and drive regulatory strategy across the Maryland campus. This on-site role partners with Product Development, Operations, and Site leadership to ensure quality, compliance, and patient safety while aligning with SQDC and growth plans.

The position oversees 150–200 QA staff, budgets, CAPA, deviations, and regulatory interactions with FDA/EMAs, delivering measurable quality improvements and an

Qualifications

• Bachelor's or Master's 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.

Responsibilities

• Lead the Quality Unit (150–200 staff) to deliver on quality, regulatory strategy and operational performance across the Maryland campus.
• Develop and maintain a meaningful Quality culture across the site in collaboration with Site General Manager and other leaders.
• Define activity-based cost models and manage the budget to support testing, release and QMS needs.
• Ensure metrics, reporting and CAPA processes drive improvement and adherence to quality standards.
• Lead regulatory inspections and responses, oversee deviations and corrective actions, and maintain strong customer relationships.

Skills

Leadership

Strategic thinking

Regulatory knowledge

Budget management

Communication

Education

Bachelor's or Master's Degree in Science, Pharmacy, or related discipline

Job description

Senior Director of Quality

Position Summary

• 100% on-site in Harmans, MD

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.

The Role

• 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.

The Candidate

• 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.

Preferred Skills & Background

• 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.

Pay

The anticipated salary range for this position in Maryland is $250,000-350,000 plus an annual bonus target. The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.

Why You Should Join Catalent

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.