Sr. Supplier Quality Associate
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.
- Provide support and oversight for new and actively managed Supplier Change Notifications (SCNs) and supplier investigations.
- Participate, with potential to facilitate, in cross-functional Supplier Quality meetings.
- Support development of Supplier related policies, and continuously evaluate and improve practices and systems to coordinate with validation, documentation, and regulatory systems. Strive toward constant improvement of systems in order to maintain compliance cGMP requirements for work performed.
- Assist in development, implementation, and enforcement of departmental policies and procedures.
- Participate in inspection preparation, train employees in focus areas and participate in regulatory inspections.
- Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin and for Supplier related approaches utilized at BioMarin.
- Other duties as assigned.
- 5+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems, specifically Change Control.
- Strong ability to comprehend technical information related to raw material, process and regulatory expectations
- Proficiency with standard software applications, including MS Excel, Adobe Acrobat
- Understanding and familiarity with FDA, European, PMDA guidelines
- Exceptional organizational, spelling, grammar and typing skills.
- Effective leadership and communication skills.
- Experience with TrackWise preferred.
- Experience working with international project teams preferred.
- BA or BS in a technical discipline (physical or biological sciences).
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.