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Associate, Global Supplier Quality

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
Aug 28, 2021

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Job Details

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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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