Senior Director, Quality

Senior Director, Quality Position Summary 100% onsite Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer’s. The Senior Director of Quality is a member of the site leadership team and is expected to lead in a manner that promotes and drives a Patient First culture throughout the organization. The Senior Director of Quality is directly responsible for the Site Quality Directors/managers under their responsibility and drives “One Catalent” quality standards across the organization, ensuring that the systems necessary to produce products in conformance with good manufacturing practices and standards are implemented and followed. The Senior Director of Quality is also responsible for establishing and maintaining positive customer relationships and providing direction to the customer and organization to address critical performance issues. The Role Partner effectively with other functional leaders (Process Development, Operations, Program Management etc.) and Site General Manager to develop and maintain a meaningful and robust Patient First and Quality culture across all aspects of the business. Champion, through clear and visible advocacy, Catalent’s Quality Management System (QMS), and ensure strong technical and leadership capability at all levels of the Quality organization. Responsibility for ensuring the site Quality teams (100-200 HC) is staffed with high caliber Quality leaders and professionals, driving strong and effective performance culture at all levels across the sites, and creating a strong succession pipeline for key leadership roles. Define activity-based cost models and establish and execute a budget that is in-line with the requirements of the business to deliver on the testing, release, and QMS commensurate with the needs of the business to operate effectively and efficiently. Ensure appropriate metrics and reporting/escalation processes are in place and being utilized to drive and improve operational execution and drive appropriate corrective actions. Drive actions and remediation as required to meet the quality performance and standards sets for the site. Drive execution and outcomes on critical deviations providing clear direction and oversight including the review and approval of critical deviations as well as effective CAPA plans. Other duties as assigned. The Candidate Bachelor’s or Master’s Degree in science, pharmacy or related discipline is required. Extensive experience (10+ yrs) in biologics is a requirement. Experience with drug substance manufacturing is required. Experience with drug product manufacturing is preferred. Demonstrated business acumen and ability to manage through difficult discussions with clients. Demonstrated experience of successfully leading Quality organizations, preferable in a matrix-style organization. Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies. Proven experience in driving substantial improvements of quality performance across a broad range of initiatives including development and recruitment of talent, process improvements, elimination of exceptions/SOP standardization. Provides reliable / defendable interpretations of regulatory guidance for the customer and is capable of defending these positions to regulatory agencies. Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience. Why You Should Join Catalent Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Dynamic, fast-paced work environment Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment 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. 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