Sr. Specialist, WWRD Quality

Location
San Rafael, California
Posted
Jun 10, 2022
Ref
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Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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 Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

The Sr. Specialist, WWRD Quality, is a role focused on quickly building subject matter expertise within the WWRD Quality organization in one or more of the key Quality Management System areas such as Controlled Document Management or eTrial Master File (TMF) Quality Management. Typically, this role will provide hands-on expertise in supporting the execution of procedures and processes, maintenance of study records, and ensure quality standards are robust and meet global regulatory requirements, company standards and quality goals. This role may also have the opportunity to participate in functional initiatives, represent the department on cross-functional initiatives, and take on the Quality Program Representative role. 

A track record of proficiency in the following is expected:

- agile and proactive problem solving

- driving for results in self and the team

- communicating and collaborating clearly and effectively

- knowledge and experience working with Quality Management Systems

- understanding of data systems and clinical study essential documents

Education/Experience: Bachelors’ Degree (BA/BS), from an accredited college or university or commensurate work experience.

  • Experience working in the biotech/pharmaceutical industry specifically in the area of quality assurance area is preferred
  • Strong working knowledge of regulatory regulations and guidelines include FDA, ICH, and EMA.  (Both GCP and GLP experience preferred)

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.