Associate Director, Development Sciences Quality

Location:  San Rafael, California Category: Quality

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 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 Development Sciences Quality (DSQ) group is focused on partnering with Development Sciences functional groups, project teams and study teams to proactively promote, facilitate and verify the implementation of, and adherence to, good quality practices across the drug development lifecycle in order to be inspection ready at all times. DSQ achieves this by implementing, maintaining and continuously improving a quality management system which includes robust quality operations oversight, controlled document management, eTMF and records management, inspection readiness and response support and training development and delivery.

The Associate Director position is a leadership role for highly experienced employees who are masterful facilitators, quality management leaders, and change managers. As a highly experienced and well-respected leader, the Associate Director plays a pivotal role in setting the strategy and direction of the functional area and is a key leader of cross-functional quality initiatives. The Associate Director will oversee DSQ activities and personnel in the Quality Operations area.

Core Deliverables

  • Lead process improvement of the QE/SOP Deviation/CAPA process
  • Coordinate DSQ Independent Quality Review processes for documents and procedures that include critical clinical & regulatory documents (e.g., investigator brochure, ICFs, CSRs, etc.) and SOP driven deliverables
  • Oversee the DSQ trend analysis and risk management programs
  • Monitor DSQ metrics and reporting to DSMMR (Compliance Governance)

Management of DSQ personnel to support DSQ deliverables to study teams and functional areas.

  • BA/BS in life sciences or technical area; advanced degree preferred. Experience in lieu of education may be considered.
  • 10+ years of relevant pharmaceutical industry experience
  • 3+ years of people management experience

Relevant certification, such as Registered Quality Assurance Professional, Certified Quality Auditor, CCRA or CCRC, Certified Clinical Research Professional, or Regulatory Affairs Certification a plus

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