Sr. Assessment Manager/Principal Assessment Manager, GMP Compliance Audit
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.
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 regulations and BioMarin quality requirements through periodic assessments of internal and external operations for the manufacture, testing and storage of GMP regulated clinical and commercial products.
This role will support the BioMarin global GMP Compliance Program:
- Prepare and lead complex GMP audits across multiple, internal sites and third parties both domestic and international.
- Domestic and International travel required (~50%) to perform audits and related activities
- Serve as a cGMP consultant/subject matter expert, providing researched and fact-supported information and opinions, often on complex issues that lack standard precedence.
- Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.
- Escalate issues of critical noncompliance
- Lead remediation efforts in a collaborative manner.
- Assess responses for adequacy
- Participate in due diligence activities and process improvement initiatives, as requested
- Work closely with supervisor to manage current issues and anticipate upcoming auditing needs outside of assigned programs
- Other duties as assigned
This position is responsible for executing all facets of compliance audits. Also responsible for evaluating and improving GMP compliance levels and inspection readiness of BioMarin sites.
Acts independently to determine methods and procedures on new or special assignments. Works on complex problems and significant issues where analysis of situations and data requires an in-depth evaluation of variable factors. Exercises independent judgment in reviewing, developing and negotiating appropriate audit responses. Creates formal networks with key contacts outside own area of expertise, involving coordination among groups.
Bachelor’s with a life science focus. Advanced degree in scientific discipline is a plus.
- Extensive knowledge of GMP regulations with 10+ years of experience within a regulated healthcare industry. Experience with other GXP’s is a plus.
- Ideal candidate will have broad experience in clinical and/or commercial operations.
- Working knowledge of FDA Regulations, local country regulations, application of Good Manufacturing Practices.
- Strong verbal, written and oral communication skills. Able to present business indicators to Senior Management
- Able to work independently and be flexible to changing priorities.
- Strong computer skills including word processing, spreadsheets, and presentations.
Work EnvironmentThis position will be based at the San Rafael Corporate (SRC) campus. When not traveling, it is expected to be in the office to interact at meetings and with stakeholders. Routine travel between the San Rafael and Novato campuses is required to engage with stakeholders, provide training/support and participate in meetings.
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.