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Associate Director, Technical Operations Training

Location Novato, 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.

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

The Associate Director, Technical Operations Training is responsible for the oversight and governance of the training systems and processes for BioMarin’s Technical Operations department, including direct oversight of the Quality department training program. This role is the Business Process Owner for the training system, which is primarily focused on GxP, technical and relevant business training needs.

The incumbent will lead the development and execution of the training strategy for the Quality department, and partner with the various TOPS training organizations to develop and implement the Technical Operations training strategy, including the annual GxP training plan. The incumbent will ensure that the training system is adequate to comply with local and global health authority regulations while also supporting a diversified workforce. In addition, the incumbent will directly oversee personnel supporting the Quality training program, as well as other global functions.

RESPONSIBILITIES

  • Designated Business Process Owner for the Technical Operations Training Systems. Includes the leadership of a cross functional group of training professionals to define and align standard training business practices.
  • Performs training needs assessments and develops actions plans for addressing training needs within the organization.
  • Delivers key global training programs especially focused on key GxP and quality systems topics.
  • Develops and implements core training curricula for GxP requirements including the annual GxP training plan.
  • Owns and coordinates updates of all global training policies and procedures within the Technical Operations organization.
  • Ensures training effectiveness through the establishment and implementation of a training effectiveness program which includes a risk based approach to assessments and the definition of clear and meaningful training metrics.
  • Accountable for the training support for the global departments within the Technical Operations organizations without dedicated training support. 
  • Leads and drives aligned implementation of key projects to ensure ongoing compliance with training regulations and industry standards.
  • Represent TOPS as the process owner for training database and representation of training business practices within the training database.
  • Works cross functionally with leaders inside and outside of Technical Operations to agree on strategies and define actions regarding training system and implementation of the training program.
  • Build and lead successful cross functional teams required to drive continuous improvement within our training systems and programs.

SCOPE

The work of the Associate Director, Technical Operations Training will directly impact product revenue through the development of a flexible workforce through the implementation of a compliant and efficient training GxP and technical training program.

The Associate Director, Technical Operations Training is a member of the Quality Business Operations leadership team and has direct reports. It also leads a cross functional group of training peers to ensure organizational alignment to training policies. 

EDUCATION

BS/MS/B.Sc/M.Sc./PhD preferably in the life sciences. 

EXPERIENCE

  • 12+ years of experience in pharmaceutical or related industry
  • 6+ years of previous people management preferred.
  • Formal education and/or work experience in the training, teaching or adult learning field.
  • Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in a manufacturing processes.  Knowledge of devices, combination products and device development desirable.
  • Demonstrated knowledge of learning management systems.
  • International/global experience preferred
  • Proven leadership, organizational and management skills to coordinate cross functional decision making with executive leadership.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors.
  • Ability to comprehend technical information related to analytical methods, processes, and regulatory expectations.
  • Experience with participation in regulatory inspections presenting or defending subject matter area in audits or regulatory inspections.
  • Understanding and familiarity with FDA, European and international regulatory requirements, guidelines. In particular understanding of GxP training regulations and industry best practice.

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. #LI-SM1

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Novato

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