Senior Director Quality, BioPharma Manufacturing

Senior Director, Quality-100% onsite in Madison, WIThis is an exciting executive leadership position responsible for overseeing strategic Quality operations within a best-in-class Global Contract Manufacturing Organization (CMO). You will be 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.* Defining, developing and overseeing company Quality functions and roadmaps including Quality Strategy & Implementation, Compliance and Risk Management Strategy, Client & Regulatory Agencies Relationships Management, and Resources & Quality Innovation Management.* Responsibility for ensuring the site Quality teams (100-200HC) 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.* Overseeing and managing the Quality organization's budget, ensuring all budgets meet company targets.* Communicating, deploying and executing the company's Quality roadmap across the organization.* Ensuring the adherence to the company Compliance Risk Management program which manages risks associated with deviations from regulatory requirements.* Providing input on issues, opportunities, risks, and risk management to clients.* Supporting Regulatory submissions and inspections across sites, advising on best regulatory path to accelerate approval.* Leading, developing, and executing quality and regulatory initiatives in compliance with company procedures and ethics.* Supporting Innovation strategies in line with quality processes, including reporting of Performance of a Lean culture.* Ensuring necessary resources are available to support the execution of quality, regulatory, and compliance objectives.Desired Skills & Experience:* BS, or Master's Degree in Biology, Biochemistry, Chemistry, Molecular Biology, or related Scientific/Engineering field 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.* Exceptional strategic team leadership and functional Quality organizational leadership experience.* Knowledge of global cGMP regulations including FDA, EMA, ANVISA, and other Tier 1 regulatory agencies.* Experience leading multiple Quality operations, organizational strategies, roadmaps and functions for large organizations.* Expertise leading Compliance initiatives within a large-scale organization.* In depth understanding of life science operations and business practices, throughout product life cycles, for the development of large molecule drugs and therapeutics.