Catalent
Pharmaceutical
Director,Quality
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optimal for Director candidates.
“Director, Quality at Catalent. Skills: Quality Management, Regulatory Affairs, Clinical Supply Packaging. Provide direction and guidance to Quality Disposition. Provide direction and guidance to Materials Sampling Quality”
Industry & Context.
Problem-solving; Decision-making; Root cause analysis
What They're Looking For.
Must Have
BS or BA in Chemistry, Biological Sciences, or other related scientific discipline or equivalent experience, 10+ years of Scientific or Pharmaceutical Quality Assurance experience, Clear understanding of cGMPs including clinical trials, Communicates clearly with internal and external clients, both verbal and written, Demonstrates flexibility in organizing work and priorities, Good organizational skills relating to management of associates’ daily activities, Good problem-solving skills and decision-making skills, Good change management skills and strategic thinking
Nice to Have
Preferring clinical supply services, in addition to commercial packaging, Demonstrable leadership experience at Catalent may be considered in place of external experience
What You'll Do.
Provide direction and guidance to Quality Disposition
Provide direction and guidance to Materials Sampling Quality
Provide direction and guidance to Regulatory and Compliance
Provide direction and guidance to Validation Quality Assurance
Manage professional development for direct reports
Conduct performance appraisals for direct reports
Provide employee counselling for direct reports
Assign work for direct reports
Review workload for direct reports
Supervise staff by establishing goals
Delegate tasks commensurate with skill level
Recommend courses of action on management/human resources’ matters
Promote quality initiatives of processes and programs
Implement quality initiatives of processes and programs
Maintain quality initiatives of processes and programs
Assess compliance with regulations
Assess compliance with Global and Site SOPs
Assess compliance with client requirements
Provide consultation to Operational CDS and Quality organization
Provide interpretation of regulations/guidelines related to GXPs
Write Quality unit SOPs and Forms
Approve Quality unit SOPs and Forms
Approve Operational CDS SOPs and Forms
Support harmonization of worldwide Quality operating procedures
Provide leadership for Data Integrity documentation review
Provide leadership for Computer System Validation documentation review
Assist with Client Audits
Assist with Regulatory Agency inspections
Provide direction in identification of quality improvement programs
Provide direction in implementation of quality improvement programs
Provide leadership for investigation of Deviations
Provide leadership for root cause analysis of Deviations
Provide leadership for CAPAs association with Deviations
Provide leadership for investigation of Non-conformances
Provide leadership for root cause analysis of Non-conformances
Provide leadership for CAPAs association with Non-conformances
Provide leadership for investigation of Complaints
Provide leadership for root cause analysis of Complaints
Provide leadership for CAPAs association with Complaints
Provide leadership for investigation of Client Audits
Provide leadership for root cause analysis of Client
Provide leadership for CAPAs association with Client Audits
Provide leadership for investigation of Internal Audit Reports
Provide leadership for root cause analysis of Internal
Provide leadership for CAPAs association with Internal Audit
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Internal clients; External clients; Operational CDS; Quality organization; Client Audit; Regulatory Agency inspections
Communication Scope
Verbal communication; Written communication
Full Job Description
**Director, Quality** **Position Summary:** * 100% on-site Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. Come and be part of a team that delivers industry-leading quality and innovation. The Quality function is to build, monitor, and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations. Components of the quality system establish the requirements for and measure how Catalent complies with all applicable regulations and guidance world-wide, including but not limited to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and Australian agencies and other international and/or local health authorities. The Director of Quality is responsible for providing leadership and Quality Management support within each of the Clinical Specialty Services divisions. This individual will have responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, and Customer relations. **The Role:** * Provides direction and guidance to the Quality Disposition, Materials Sampling Quality Assurance, Regulatory and Compliance Quality Assurance, and Validation Quality Assurance. * Management responsibilities include professional development, performance appraisals, and employee counselling for direct reports. Assigns work and reviews workload for all direct reports. Supervises staff by establishing goals that will increase knowledge and skill levels, and by delegating tasks commensurate with skill level. * Recommends courses of action on all management/human res
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