Sr GMP Compliance AuditorLocation Dublin, Ireland Apply
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.
LOCATION: Dublin / Cork / Home Working
BioMarin is a global, high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, self-motivation and organization are essential role requirements. This position will play a key role in executing BioMarin’s GMP Compliance Program. The overall purpose of this program is to ensure continuous compliance with applicable global GMP/GDP regulations and BioMarin quality requirements through periodic assessments of internal operations; domestic and international third parties (i.e. suppliers, contract manufacturers, contract laboratories, commercial distribution partners and key service providers) responsible for providing materials and services for the manufacture of GMP regulated clinical material and commercial finished products. The primary responsibility of the position is the planning and execution of audits to assess ongoing compliance with government regulations and corporate standards of BioMarin suppliers and internal sites. All employees are required to follow defined processes and policies; behave in a professional manner with integrity and strive for right first time performance.
This role will support the global BioMarin supplier quality management program participating in audits of various types of contractors and suppliers.
Domestic and International travel required (50%)
BS in life sciences or engineering preferred, but other technical/scientific areas or equivalent education/experience combinations will be considered.
Key interactions for this position include peer stakeholders in stakeholder departments such as QA, Purchasing and Manufacturing as well as senior management regarding compliance assessments.
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.