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Associate Director Training, GxP Compliance

Location San Rafael, California
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.

SUMMARY:

This position will have two primary responsibilities: creation of a centralized training program for the GxP Compliance organization using a variety of training methods, and managing the external training and education program where training is provided by GxP Compliance to other business units. Scope includes the associated business processes and use of the Learning Management System (LMS). Centralizing and coordinating the training elements (such as defining curricula, training tasks, competencies, etc.) within GxP Compliance is an important focus for this role.  The candidate is responsible for developing, communicating and deploying the training and education strategy for the GxP Compliance Organization.  This individual will also serve as the GxP Compliance representative in any corporate training program forums. 

RESPONSIBILITIES:

  • Manage GxP Compliance training (business process and LMS oversight) to ensure that the system is effective and efficient.
  • Ensure staff are assigned appropriate curricula and have a combination of training, education and experience to execute assigned responsibilities.
  • Collaborate with internal disciplines in creating meaningful individual development plans (IDPs), monitor and drive their execution to support cross training development in other areas and a flexible work force.
  • Create job specific matrices to facilitate staff growth and cross training. Develop and launch training modules for staff.
  • Define and support roles and responsibilities for Compliance Training in collaboration with other training groups. Implement and maintain procedures and policies for the training program.
  • Support the revisions to GxP Compliance Standard Operating Procedures and creation of applicable training requirements.
  • Partnering with internal and external departments’ training representatives in creation and execution of Lunch & Learn education series. Establish formal requirements, content and schedule for the program.  Ensure documentation of course content and attendance.
  • Support training programs/modules for inspection readiness. Create, monitor, manage and maintain meaningful training metrics.
  • Measure and improve customer satisfaction levels.
  • Manage GxP Compliance intranet webpage content.
  • Follow defined processes and policies; behave in a professional manner with integrity and strive for right first-time performance.
  • Perform other tasks as assigned
  • Up to 5% travel

EDUCATION:
  • Bachelors or Masters Degree in related field

EXPERIENCE:
  • Minimum of 10+ years related experience or equivalent training and experience. Experience may be in other regulated industries.
  • Recognized as a strong leader with a proven track record of effectively managing, influencing and developing people including those who are not direct reports.
  • Experience should include responsibility for leading a training program, training design and familiarity with learning management systems (LMS).
  • Demonstrated ability to lead and deliver results in a matrix environment, and solve complex issues that cross multiple stakeholders.
  • Experience with project management and program implementations desired.
  • Exceptional written and verbal communications skills with ability to present to all levels and audiences.
  • Able to take a consultative approach to understand requirements and resolve issues. 


WORK ENVIRONMENT / PHYSICAL DEMANDS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration.  The noise level in the work environment is usually moderate.

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.

This position may require travel, including but not limited to, airplane and automobile.



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.

~BIO

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San Rafael

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