Manager - Quality Assurance Operations, Client Quality

Catalent Pharma Solutions • Madison, WI

1d • Onsite

About The Position

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.

Requirements

• Doctorate Degree in STEM discipline with minimum of 4 years related experience, OR Master's Degree in STEM discipline with minimum of 7 years related experience, OR Bachelor's Degree in STEM discipline with minimum of 9 years related experience
• Leadership experience minimum of 4 years

Responsibilities

• 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
• Work with, coach, and support direct reports in developing knowledge, skills, 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 operations; including developing and reporting performance metrics, identification, and implementation of improvement opportunities for established processes, procedures, 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, implementation, and approval
• 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, system improvement, new regulations/expectations, new business needs, 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.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees