Senior Director, Quality Assurance & Compliance

Regulatory Jobs; Kansas City (MO); Sur place; USD 150 000 - 210 000; Plein temps

Avantages offerts par ce poste

Generous 401K match

Paid Time Off accrual

Medical/dental/vision benefits

Résumé du poste

Catalent’s Kansas City facility is a Center-of-Excellence for Biologics Analytical Services, and the Director of Quality leads the CSS organization with a strong focus on global quality strategy, regulatory compliance and site performance. This senior role requires extensive QA/RA experience, cross-functional leadership, and a proven history of improving GMP systems.

Responsibilities include policy development, audit readiness, investigations, and ensuring robust validation and documentation

Qualifications

• BS Degree (or regional equivalent) in a Science, Engineering or Pharmaceutical discipline required.
• 10+ years of experience in a chemical, pharmaceutical, food or relevant industry with 5+ years in QA/RA.
• Experience in managing people and developing personnel.
• Direct experience with Validation principles (process, equipment, systems, analytical methods, cleaning, transportation).
• Working knowledge of US and international cGMP regulations and regulatory agencies.
• Proven record of implementing and maintaining quality systems and driving improvements.
• Leadership experience at Catalent (programs such as NGGL, GOLD, LEAD Now, GM Excellence, GROW) may be considered in place of external experience.

Responsabilités

• Global Leadership: develop and implement quality strategy, policies and harmonization across business units.
• Site Leadership: lead site Quality Objectives, Plans and management reviews with the Site Leadership Team.
• Department Leadership: oversee QA/RA functions and performance management actions.
• Lead internal investigations on cGMP issues, trends and customer complaints.
• Review and approve GMP documentation and validation reports for cGMP compliance.
• Drive process integration and procedural harmonization across CSS sites.
• Coordinate customer and regulatory audits and Catalent responses.
• Perform other duties as assigned.

Connaissances

Leadership

People management

Regulatory knowledge

Quality mindset

Problem solving

Formation

BS Degree in Science/Engineering/Pharma

Description du poste

Catalent’s Kansas City facility is a Center-of-Excellence for Biologics Analytical Services, and the Director of Quality leads the CSS organization with a strong focus on global quality strategy, regulatory compliance and site performance. This senior role requires extensive QA/RA experience, cross-functional leadership, and a proven history of improving GMP systems.

Responsibilities include policy development, audit readiness, investigations, and ensuring robust validation and documentation