Senior Director, Site Head of Quality

Catalent Pharma Solutions; United States; Vor Ort; USD 200.000 - 260.000; Vollzeit

Benefits dieser Stelle

401K match

Paid Time Off accrual

Medical, dental and vision benefits

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Leadership

Regulatory knowledge

Quality management

Biologics experience

Ausbildung

Bachelor's degree in science

Master's degree

Jobbeschreibung

Senior Director, Site Head of Quality

Position Summary: 100% onsite. Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s.

The Senior Director of Quality is a member of the site leadership team and is expected to lead in a manner that promotes and drives a Patient First culture throughout the organization. The Senior Director of Quality is directly responsible for the Site Quality Directors/managers under their responsibility and drives "One Catalent" quality standards across the organization, ensuring that the systems necessary to produce products in conformance with good manufacturing practices and standards are implemented and followed. The Senior Director of Quality is also responsible for establishing and maintaining positive customer relationships and providing direction to the customer and organization to address critical performance issues.

Role

Partner effectively with other functional leaders (Process Development, Operations, Program Management etc.) and Site General Manager to develop and maintain a meaningful and robust 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 teams (100-200 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 operational execution and drive appropriate corrective actions.

Drive actions and remediation as required to meet the quality performance and standards sets for the site. Drive execution and outcomes on critical deviations providing clear direction and oversight including the review and approval of critical deviations as well as effective CAPA plans. Other duties as assigned.

Candidate

• 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.
• Experience with drug product manufacturing is preferred.
• Demonstrated business acumen and ability to manage through difficult discussions with clients.
• Demonstrated experience of successfully leading Quality organizations, preferable in a matrix-style organization.
• Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.
• Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization.
• Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies.
• 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.

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
• Dynamic, fast-paced work environment
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Catalent offers rewarding opportunities to further your career!

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.

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.