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Director – R&D Compliance Audit

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.

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.

Associate Director – R&D Compliance Audit

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.  The Associate Director is a key leadership position that is responsible for overseeing all R&D Compliance Audit activities, including the planning and execution of audits to assess ongoing compliance with government regulations and corporate standards. This role is also responsible for the management of R&D Audit employees, including staff development, recruitment, and team leadership.

Responsibilities

Essential Functions

  • Collaborate with leaders of GxP Audit to set strategy and business objectives and contribute to vision, policies, processes, and strategic and operational decisions
  • Assist with Compliance operational and corporate projects
  • Create a cohesive, balanced, and high-functioning team focused on driving continuous improvement for the organization
  • Manage recruiting, hiring, and evaluations in collaboration with HR and GxP Audit Functional Head for managed staff
  • Identify skillset /expertise gaps and create the potential for cross-pollination across the Audit Group
  • Determine appropriate assignment of audits to team members based on level of complexity and risk in association with auditor experience
  • Provide feedback to the Audit Program Management team on annual audit plan and schedule throughout the year to guide the audit selection, resourcing and execution
  • Act as escalation point, supporting the team on the identification and resolution of issues, including critical noncompliance, risk management, and inspection related risks.

Scope

The Associate Director will have significant influence on functional area strategy and operations.

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

BA/BS degree (advanced degree preferred) in life sciences or a related technical or scientific discipline

Experience/Abilities

  • Extensive knowledge of GLP, GCP and GVP regulations with 10+ years of experience within a regulated healthcare industry.
  • 3 or more years of people management experience
  • 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

Work Environment

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.

The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. Frequent domestic and international travel required (>50%).

Note:  This description is not intended to be all inclusive or a limitation of the duties of the position.  It is intended to describe the general nature of the job as assumed or assigned.

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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