Associate, Global Supplier Quality

Location:  Novato, California Category: Quality Employment Category: Fulltime-Temporary

Description

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. 
 
 

Duties


ROLE


 


We are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.


 


A high-level of initiative, energy, and motivation are key role requirements, as well as organizational skills and the ability to motivate others.


 


This position supports the Global Supplier Quality processes for implementing, maintaining, and monitoring Raw Material Supplier Quality Agreements.


 


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 individuals 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.

Skills


KEY RESPONSIBILITIES


 



    • Initiate, revise, and execute raw material quality agreements to ensure all identified BioMarin raw materials have quality requirement controls in place with the associated raw material suppliers.

    • Drive the process for executing effective quality agreements with internal stakeholders and raw material suppliers.

    • Maintain supplier change control registration systems.

    • Maintain a quality agreement tracking system.

    • Manage TrackWise and Veeva change control workflows for review, approval, and upload of raw material quality agreements.

    • Monitor and ensure document implementation timelines are met.

    • Monitor backlog in associated trackers.

    • Represent Global Supplier Quality in multi-departmental meetings & project teams.

    • Work cross-functionally with leaders inside and outside Technical Operations to align priorities and health of raw material quality agreements.

    • Ensure all individual training and group-specific guidelines are kept current.

    • Support Supplier Deviation activities as needed.

    • Other duties as assigned.


 


 

Education


EDUCTATION


 



    • Bachelor’s Degree or work experience that supports quality operations, supplier management, and/or contract review.


 


EXPERIENCE


 



    • Minimum 4 years of experience in a Quality, Compliance, Manufacturing, and/or Regulatory setting.

    • Strong attention to detail, organization and communication skills.

    • Ability to maintain organization of a large volume of data in a systematic manner

  • Proficiency with TrackWise, Veeva, and Office365 preferred.

 
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.