Sr. Manager – GCLP Compliance Auditor

Location
San Rafael, California
Posted
May 15, 2022
Ref
o7Qnjfwn
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
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.

Sr. Manager – GCLP Compliance Auditor

Summary

Sr. Manager – GCLP Compliance Auditor 

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.  This position will play a key role in executing BioMarin’s GLP and GCP 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 GCLP regulated clinical material and commercial finished products.  All employees are required to follow defined processes and policies; behave in a professional manner with integrity.

Responsibilities

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

  • Prepare and lead complex audits across GLP and GCP operations
    • At internal BioMarin sites and third parties - both domestic and international
    • GCLP audits of non-clinical and clinical study reports
    • Central and Specialty Laboratories (CLIA and CAP)
  • Lead pre-audit meetings with internal stakeholders to determine current audit status and review pre-audit documentation.
  • Execution of audits, including traveling to sites along with associated administrative tasks. Domestic and International travel required (>50%).
  • Preparation and distribution of audit reports
  • 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.
  • Track and manage corrective and preventative actions (CAPAs) to completion and review for effectiveness as necessary.
  • Assist in the review and identification of potential systemic gaps and coordinate with the appropriate stakeholder to ensure timely remediation.

Scope

This position is responsible for supporting the GxP Compliance Audit Program. Also responsible for evaluating and improving GLP 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

Bachelor’s Degree with a life science focus. Advanced Degree (Masters) in a scientific discipline a plus.

Experience and Abilities

  • Extensive knowledge of GLP regulations with 10+ years of experience within a regulated healthcare industry.
  • Professional certification such as RQAP-GLP (Registered Quality Assurance Professional-GLP) or ASQ-CQA (American Society of Quality – Certified Quality Auditor)
  • Working knowledge of FDA Regulations, EU GLP and local country regulations
  • 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.