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Senior Audit Manager, GxP Compliance

Location United States, Remote

Workstyle Remote Only

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 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 GxP Compliance Audit 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 of GMP regulated clinical material and commercial finished products.  All employees are required to follow defined processes and policies; behave in a professional manner with integrity. 

This role will support the global BioMarin GMP Compliance Program executing, reviewing and approving audit responses. 

Essential Functions

  • Prepare and lead complex GMP audits across multiple internal sites and third parties both domestic and international. 
  • 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.

Secondary Responsibilities

  • Participate in due diligence activities and process improvement initiatives, as requested
  • Work closely with Associate Director to manage current issues and anticipate upcoming auditing needs outside of assigned programs
  • Other duties as assigned

Scope:

This 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.  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.  Creates formal networks with key contacts outside own area of expertise, involving coordination among groups.

Education/Experience:

  • Bachelor’s degree with a life science focus.  Advanced degree in a scientific principle is a plus.
  • 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.  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. 

This position will be based remotely. Travel to San Rafael, California (Headquarters) is expected twice per year at minimum to engage in meetings with Team Members, Senior Leadership and Stakeholders as necessary.

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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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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