Manager, Development Sciences Quality
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 Manager is a critical execution position in the DSQ group. The Manager holds responsibility within the DSQ organization in the areas of: Quality Operations, Controlled Document Management, or Trial Master File (TMF) Quality and Records Management. The Manager demonstrates a significant amount of subject matter expertise and independence as s/he focuses on more complex studies and quality risks and issues. Responsibilities may include reporting and communicating SOP deviation and CAPA performance metrics, verifying adequacy of DevSci Inspection and Audit responses, essential document review and risk management. At this stage, the Manager may be offered opportunities to take on leadership roles in key internal initiatives, take on a study team representation role, and manage junior staff.
At the Manager level, an individual should demonstrate advanced abilities across multiple core competencies: Communication, Problem Solving, Planning, Teamwork, and Proactivity. Technical skills in Quality Management and Regulations and Good Practices should be advanced.
- BA/BS in life sciences or technical area; experience in lieu of education may be considered
- 6+ years of relevant pharmaceutical industry experience
- 1 or more 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
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.