Sr. Manager, GxP Compliance

Location:  Novato, California Category: Compliance

Description

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.

Senior Manager, GxP Compliance

The Senior Manager of GxP Compliance Strategy will support the management of Health Authorities Regulatory Inspections including but not limited to, participation in the on-going inspection readiness activities, pre-inspection preparation, execution of the inspection and post inspection follow-up activities. In addition, support Distribution Compliance activities in the United States acting as quality role for post distribution activities.

This position requires cultural awareness, relationship building, ability to influence at all levels of the organization, sound judgment and the ability to make difficult decisions, often at short notice. In addition, to the ability to multi-task while delivering high quality work, and the capability to work effectivity in a rapidly changing environment. The role will interact closely with all levels of management and staff as well as third parties contract manufacturing and laboratories providers.

Responsibilities:

  • Within in BioMarin, assist with inspection readiness effort including but not limited to participation in the on-going readiness team meetings, providing general and custom inspection awareness training, assist functional area with walk-though as needed, tracking of inspection commitments, and provide inspection trends as requested. For third party GxP pre-approval inspections, support the sites in their preparation activities to ensure successful outcome.
  • Collaborate cross-functionally and interact with all facet of the organization on pre-inspection readiness activities, including inspection notification communications, targeted country training, preparing of inspection requests, inspector’s intelligence and trends, review of previous inspection commitments to ensure that inspection commitment intend are met; management of inspection logistics and participate in mock inspections.
  • Lead and / or support the various BioMarin GxP inspections backroom teams and participation in the front room to ensure smooth execution of the inspection, including fulfillment of inspection requests in a timely manner and management of daily logistics to ensure that the inspectors needs are met. In addition, facilitate daily wrap-up meetings and prepare for next day requests. Support BioMarin third party inspection by acting as a liaison between CMO, CLOs and BioMarin SMEs.
  • Ensure inspection commitments are communicated, escalated as required, track to completion and ensure that the intended CAPAs are effective and in compliance with internal policies as well as with all applicable regulatory requirements.
  • Provide Inspection support for BioMarin regional offices
  • Compile inspection program metrics as required and report out to the various committees
  • Prepare and deliver regulatory inspection risk summaries to senior management.
  • Ensure that company and department goals and objective are met.
  • Promote compliance culture by participating in GxP Compliance Assessment for moderate to complex technical situations diverse in scope with broad impact across the organization and multiple products against international GxP Regulations and BioMarin internal policies and procedures.
  • Work closely with multiple stakeholders to ensure maintenance of the supply chain compliance to the Good Distribution Practices (GDP) within the US territory, including participation in product investigations, returns and recalls.   

 

EDUCATION

Bachelor’s Degree in Life Science or other technical/scientific area and 10-15 years of industry experience.

EXPERIENCE

  • Ten (10) or more years of experience in a biologic or drug GxP environment.
  • Audit or Inspection experience highly desirable.
  • Program and/or Project management skills.
  • Ability to lead multiple projects at a time and to shift between various projects as required.
  • Experience with using and running reports from GxP database systems such as Veeva, Track Wise, Compliance Wire, Microsoft Office suite programs (Word, Excel, PowerPoint, Access and Project) Oracle EBS and LiveLink. 
  • Demonstrated interpersonal (influencing and negotiating skills), leadership, planning, problem solving, team building & management, and organization skills.
  • Excellent communication skills, both written and orally, across all levels of management and across different geographies and cultural backgrounds.
  • Experience in use of Quality Tools such as benchmarking, gap analysis, pareto analysis, fish- bone diagrams, and process mapping for fact base decisions making is desirable.
  • Supervisory / Management experience is preferred
  • Up to 20% travel required

CONTACTS

External:  Providers of Contract Services, Regulatory Inspectors

Internal: BioMarin Pharmacovigilance; Medical Information Services; Non-medical Complaints; GMP, GCP and GLP Compliance; Regulatory Affairs and Operations, Clinical Development, Technical Operations and Biometrics.

Supplier Quality Compliance; Quality Assurance; Quality Control; Materials Management; Supply Chain; and Document Control. Legal, US and International Commercial Operations, and IT.  Product Development, Supply Chain, CMO group.


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.