Manager, Quality and Compliance

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 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! * 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. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to View email address on click.appcast.io. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to View email address on click.appcast.io for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.