Manager, Quality and CompliancePosition Summary:- Work Schedule: M-F 8am-5pm
- 100% on-site
Catalent Pharma Solutions in Madison, WI is hiring a Manager, Quality and Compliance. 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 & Compliance group has oversight of internal and client audits as well as regulatory agency inspections, compliance and regulatory support initiatives, supplier quality management, and process validation activities.
The Role:- Manages the Quality Assurance resources assigned to supporting internal and customer audits, regulatory support functions, customer quality agreements, supplier quality management, and process validation activities (i.e., PPQ, CPV, APR).
- Establishes functional and overall training expectations for Quality Assurance personnel engaged in the Quality & Compliance functions.
- Understands the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
- Develops and implements strategies to facilitate compliance and foster internal and client relationships; applies advanced theoretical knowledge and contributes to the development of new principles and concepts.
- Serves as regulatory liaison with applicable Health Authorities, as assigned, and facilitates regulatory inspections.
- Recommend and supports site improvement initiatives and drives inspection readiness.
- Functions as a strong liaison to customers and other functional departments, providing meaningful quality and regulatory support and ensuring productive cross-functional communication.
- Monitors and communicates industry compliance trends and regulatory expectations.
- Leads 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.
- Works with coaches, and supports direct reports in developing knowledge, skills, and abilities in the interest of performance improvement and employee's career development.
- Other duties as assigned
The Candidate:- 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
Why you should join Catalent:- 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!
