Technical Manager/Sr. Manager, QA Systems
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Manager/Sr Manager of Quality Systems is responsible for ensuring BioMarin’s Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Training and Laboratory Investigations, are consistently administered and followed. This role will lead governance meetings, Material Review Board, CAPA Review Board and continuous improvement initiatives for Quality Systems.
Participate in inspection readiness, regulatory inspection support and self- inspection activities.
Lead internal audit activities.
Develop and refine quality system metrics.
Provide training, qualification activities and guidance for BioMain’s quality systems.
Provide metrics and trending to various quality meetings.
Works cross functionally with management within and outside Technical Operations to train and ensure consistency of use of the quality systems.
Participate in quality system improvement and process mapping initiatives.
Author and own site Quality Technical Agreements.
BS/MS/PhD preferably in the life sciences
6+ years experience in pharmaceutical or related industry.
Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.
Ability to speak and present data and defend approaches in front of audiences.
Ability to comprehend technical information related to analytical methods, processes and regulatory expectations.
Familiarity with FDA, European and international regulatory requirements.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.