Associate, Global Supplier Quality
Company: BioMarin Pharmaceutical Inc.
Posted on: November 22, 2021
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. DutiesROLE 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
- 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
- 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
- Ensure all individual training and group-specific guidelines
are kept current.
- Support Supplier Deviation activities as needed.
- Other duties as assigned.EducationEDUCTATION
- 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
- Ability to maintain organization of a large volume of data in a
- 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.
Keywords: BioMarin Pharmaceutical Inc., Novato , Associate, Global Supplier Quality, Other , Novato, California
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