Senior Assessment Manager, R&D Compliance
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.
By providing a foundation for all operations company wide, BioMarin’s General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients’ lives.
ROLE CAN BE BASED IN SAN RAFAEL, CA OR REMOTE
This position is responsible for supporting the R&D Compliance (GCP, GLP and GVP) audit program at BioMarin. It requires planning and executing of domestic and international audits to assess compliance with international regulations/guidelines (e.g., FDA, EMA, MHRA, Asia Pacific and Latin America); business agreements; corporate policies; and standard operating procedures (SOPs).
Working knowledge of global GCP, GCLP, GLP and GVP regulations, and ICH guidelines is required. In order for the candidate to be successful in this position, the candidate must possess dynamic interpersonal and teamwork skills.
· Act independently and lead internal and external audits (domestic and international) to evaluate audit-ee quality management systems, and assess compliance with regulatory standards and data integrity. Audits may include but are not limited to: non-clinical, clinical and post-marketing vendors/partners, and internal processes/systems.
o Assure audit reports are written and distributed
o Communicate audit results and observations to audit-ee and internal management
o Review and approval of corrective action and preventive action (CAPA) plans
· Provide assistance or guidance to the responsible parties in developing and completing audit CAPA plans.
· Communicate critical information regarding significant quality or patient safety risk to Senior/Executive Management and Key Stakeholder.
· Report significant and/or serious ongoing quality deficiencies to R&D Compliance Management.
· Participate in the development and/or enhancement of corporate GxP Compliance processes and procedures.
· This position will require domestic and international travel around 40% of the time.
BA/BS in life sciences, health sciences, or other technical area.
· 12+ years’ experience in the Pharmaceutical, Biotechnology or Medical Device industry; in GCP/GLP/GVP Quality Assurance auditing/Regulatory Compliance or equivalent.
· Current knowledge of global GCP, GCLP, GLP and GVP regulations including FDA, EMA, and MHRA, and ICH and OECD guidelines.
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.