Catalent Pharma Solutions
Biologics
Manager-QualityAssuranceOperations,ClientQuality
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“Manager - Quality Assurance Operations, Client Quality at Catalent Pharma Solutions. Skills: Quality Assurance Operations, Client Quality, process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, cGMP manufacturing, quality control, team leadership. Lead team members to improve and reinforce performance of others. Take responsibility for direct reports’ performance by setting clear goals and expectations, tr”
What You'll Achieve.
ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements; safeguards all systems, processes, and actions to ensure regulatory compliance; providing high quality drug products for our clients and their patients; meet site performance targets and Client expectations; KPI performance improvements
Industry & Context.
identification, and implementation of improvement opportunities for established processes, procedures, and training; responding to audit observations; developing corrective and preventive actions
100% on-site
What They're Looking For.
Must Have
Doctorate Degree in STEM discipline with minimum of 4 years related experience, Master's Degree in STEM discipline with minimum of 7 years related experience, Bachelor's Degree in STEM discipline with minimum of 9 years related experience, Leadership experience minimum of 4 years
What You'll Do.
Lead team members to improve and reinforce performance of others
Take responsibility for direct reports’ performance by setting clear goals and expectations
tracking progress against the goals
ensuring constructive feedback
and addressing performance-related concerns and issues promptly
and support direct reports in developing knowledge
and abilities in the interest of performance improvement and employee’s career development
Accountable for compliant execution of the Quality Management Systems in CGMP manufacturing and quality control including developing and reporting performance metrics
and implementation of improvement opportunities for established processes
and training to maintain robust processes and high functioning teams
Responsible for interfacing with the clients and managing internal communication to sustain and enhance the Client quality relationships
Ensures operations are executed in compliance with the Quality Management System
Ensure adequate Quality resources are provided to support GMP operations
including successful transfer of processes from development and execution of cGMP manufacturing to meet site performance targets and Client expectations
Supports change control review
Support Client and regulatory audits
including responding to audit observations and developing corrective and preventive actions
Develops and maintains employee training plans
Manages team of quality professionals by recruiting and hiring employees
developing personnel growth opportunities
supporting employee motivation and providing strategic alignment with Quality Department and site initiatives
Drives continuous improvement through leading cross function teams
to address process improvement
new regulations/expectations
training improvements and KPI performance improvements
Effectively communicates Quality vision and expectations across site
including periodic site wide GMP training in addition to focused trainings
Maintains safe and healthy work environment by establishing and enforcing organization standards
adhering to legal regulations
Other duties as assigned
How You'll Work.
Team & Collaboration
cross-functional coordination; interfacing with the clients; managing internal communication; leading cross function teams
Communication Scope
Effectively communicates Quality vision and expectations across site
Process & Methodology
process technology transfer, master batch record review and approval, change control review, implementation, and approval, developing corrective and preventive actions
Full Job Description
**Manager - Quality Assurance Operations, Client Quality** **Position Summary:** * **Work Schedule:** M-F 8am-5pm * 100% on-site Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic treatments get to patients. The business includes our proprietary GPEx cell line engineering platform, our new state-of-the-art biomanufacturing facility in Madison, WI, and our market leading biologics analytical services in Kansas City, MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology portfolio, world class manufacturing capability, and other integrated services across the Catalent network, Catalent Biologics is positioned to drive significant growth for Catalent. **Catalent Pharma Solutions in Madison, WI is hiring a Manager - Quality Assurance Operations, Client Quality.** The Quality Assurance department is responsible for all aspects of the quality assurance functions at Catalent, Madison. The department’s primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems requirements. This includes systems implementation and maintenance, documentation management, site-wide systems training, internal and external auditing, project review for accuracy and compliance, and material disposition. Quality Assurance safeguards all systems, processes, and actions to ensure regulatory compliance, which is essential in providing high quality drug products for our clients and their patients. The Quality Assurance Operations group has oversight of the manufacturing areas, including process technology transfer, master batch record review and approval, on-the-floor support, product disposition, and shipping. **The Role:** * Lead team members to improve and reinforce performance of others. * Take responsibility for
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