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. 

SUMMARY

This position reports to the Quality Assurance Operations Manager and is responsible for quality oversight of end to end processes relating to make, assess, and release for products manufactured at the BioMarin Novato site.

The ideal candidate will have strong organization, communication, and leadership skills and a background in biopharmaceutical manufacturing and quality systems.

RESPONSIBILITIES

Provide quality oversight of operations including; review and approval of documentation and change requests, batch record review, deviation/CAPA management, product changeover, and lot release.

Manage lot release activities and the communication of lot release schedules.

Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.

Provide status reports, including relevant metrics, to department and site management; actively contributing to department and site goals and objectives.

Represent BioMarin Quality Assurance including face to face visits, site audits, and Quality Review Meetings.

Support Quality Operations in internal/external audits and regulatory inspections.

EXPERIENCE

7+ years of experience in a GMP regulated environment.

Proven comprehension of technical information and regulatory expectations.

Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).

Exhibited proficiency working within quality systems.

Ability to lead cross-functional initiatives to completion.

Ability to successfully communicate with representatives from all levels within the organization.

Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.

Experience with TrackWise, Veeva Vault, Oracle systems a plus.

EDUCATION

BA or BS in a technical discipline (physical or biological sciences preferred).

EQUIPMENT

This position does not utilize any specific equipment.