What are the responsibilities and job description for the Senior Director Quality, BioPharma Manufacturing position at Laguna Source?
Senior Director, Quality-100% onsite in Madison, WI
This 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.