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.
This position reports to the Sr. Manager of Global Supplier Quality and will maintain Quality oversight of one or more areas of the Supplier Quality system.
- Plan, organize, and manage the functions of one or more areas of the Global Supplier Quality system, with respect to implementation and execution of policies and practices.
- Provide Quality Assurance review and/or approval for Supplier related activities impacting GxP operations at BioMarin, including and not limited to Changes, Deviations and Technical Agreements.
- Compile Supplier Performance metrics; including metrics for supplier changes, deviations, and other measures of supplier performance.
- Lead cross-functional Supplier Quality meetings.
- Develop 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.
- Provide support of Raw Material Specification review/approval.
- Represent Global Quality Assurance in multi-departmental meetings & project teams.
- Assist in development, implementation, and enforcement of departmental policies and practices.
- Participate in inspection preparation, train employees in inspection requirements 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.
- Support CMC regulatory filings for all drug products.
- Other duties as assigned.
- 8+ years experience in a GMP regulated environment, with exhibited knowledge and proficiency working within quality systems (specifically Change Control) preferred.
- 4+ years experience in a management or supervisory position, with direct experience overseeing Supplier Changes preferred.
- Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to regulatory expectations.
- Experience with cross functional project management.
- Experience in participation in regulatory inspections, with experience in presenting or defending departmental functions in audits or regulatory inspections preferred.
- Experience with TrackWise preferred.
- Experience working with international project teams preferred.
This position requires ability to utilize a computer to perform tasks, including report generation.
Ability to perform gown activities and enter the manufacturing plant and QC laboratories is required.
Ability to navigate the non-gowned areas of the facility, including utility yard and mezzanine is required.