Sr. Audit Manager GxP Compliance Audit

Profile

Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more. And the more people we reach, the more our impact can grow. We transform lives through genetic discovery. Our Culture Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard u2013 so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients. By providing a foundation for all operations company wide, BioMarinu2019s 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 patientsu2019 lives. Summary: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.u00A0 This position will play a key role in executing BioMarinu2019s GxP Compliance Audit Program.u00A0 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 of GMP regulated clinical material and commercial finished products.u00A0 All employees are required to follow defined processes and policies; behave in a professional manner with integrity.u00A0Responsibilities:This role will support the global BioMarin GMP Compliance Program executing, reviewing and approving audit responses.u00A0 u00A0Essential Functions: Prepare and lead complex GMP audits across multiple internal sites and third parties both domestic and international.u00A0 Lead vendor audit scheduling and prioritization. Lead pre-audit meetings with internal stakeholders to determine current audit status and review pre-audit documentation. Define the audit agenda, focusing on high risk areas. Execution of audits, including traveling to sites along with associated administrative tasks. Domestic and International travel required (>50%). Preparation of audit reports in Trackwise system. Distribution of audit reports to appropriate auditees and appropriate internal stakeholders. Serve as a cGMP consultant/subject matter expert, providing researched and fact-supported information and opinions often on complex issues that lack precedence. Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. Lead de-brief meetings with internal and external stakeholders to communicate audit outcomes. Escalate issues of critical noncompliance and collaborate/lead remediation efforts. Manage audit responses, including assessing whether response meets regulatory authority, local authority, and BioMarin requirements. Partner with GxP Strategy to obtain regulatory intelligence business risk area guidance as needed. Track and manage corrective and preventative actions (CAPAs) to completion and review for effectiveness as necessary. Serve as subject matter expert for GMP audits, providing researched fact-supported information and expectations on complex issues that often lack precedence. Communicate regularly with commercial and other partners to build relationships and identify audit needs. Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation. u00A0Secondary Responsibilities: Participate in due diligence activities and process improvement initiatives, as requested Work closely with Director to manage current issues and anticipate upcoming auditing needs outside of assigned programs Other duties as assignedScope: u00A0This position is responsible for supporting the GxP Compliance Audit Program. 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.u00A0 Works on complex problems and significant issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercises independent judgment in reviewing, developing and negotiating appropriate audit responses.u00A0 Creates formal networks with key contacts outside own area of expertise, involving coordination among groups.u00A0Education:Bacheloru2019s Degree with a life science focus. Advanced Degree (Masters) in a scientific discipline a plus.u00A0Experience/Abilities: Extensive knowledge of GMP regulations with 10 years of experience within a regulated healthcare industry. Ideal candidate will have broad experience in clinical and commercial operations with regulatory experience. Working knowledge of FDA Regulations, EU GMP, local country regulations, application of Good Manufacturing Practices. Strong verbal, written and oral communication skills. u00A0Able 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. PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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