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Sr. Assessment Manager/Principal Assessment Manager, GCP Compliance Audit

Location United States
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 Clinical Compliance (GCP) Program.  The overall purpose of this program is to ensure continuous compliance with applicable global regulations and BioMarin clinical requirements through periodic assessments of internal and external operations related to clinical activities.

Responsibilities

 This role will support the BioMarin global GxP Compliance Program:

Essential Functions

  • Prepare and lead complex GCP audits across multiple, internal sites and third parties both domestic and international. 
  • Domestic and International travel required (~50%) to perform audits and related activities
  • Assure the integrity and quality of clinical data through the independent management, leading, participation and follow-up of routine and directed; internal and external; domestic and international GCP audits. Audits include, but are not limited to: vendors, study reports and internal systems.
  • 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

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 executing all facets of GCP audits. Also responsible for evaluating and improving GCP 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.

Education

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

Experience/Abilities

  • Extensive knowledge of GCP 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 conducting GCP audits including vendors such as CROs, clinical and bioanalytical laboratories, central imaging /central reading, home healthcare agencies, translation companies, central IRBs and biospecimen storage facilities.
  • Working knowledge of FDA Regulations, local country regulations, application of Good Clinical Practice.
  • 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 Environment

This position is remote.  Preference for candidate to be based in Northeast, given locations of audit sites.

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.

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