Manager, Quality and Compliance

Catalent Pharma Solutions•Madison, WI

1d•Onsite

About The Position

Manager, Quality and Compliance 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 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

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

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

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!
Catalent offers rewarding opportunities to further your career!
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.
Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us.
Join us in making a difference.
personal initiative.
dynamic pace.
meaningful work.