Sr. Technical Manager Global TrainingLocation Novato, California
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.
The Sr. Technical Manager of Global Training is responsible for the implementation of the global training program in Technical Operations. This individual is responsible for the identification of the training needs of the assigned departments, ensuring the existence and execution of required training plans and conducting relevant training (e.g. GMP training). The focus areas are compliance and technical training, with additional support for business process trainings as needed.
The incumbent will partner with the various TOPS organizations including Process Sciences, Supply Chain, and Quality Assurance to deliver and develop department level training and implement the global training strategy including the annual training plan. The incumbent will assist in the administration of the electronic training database.
- Primary training support for assigned Technical Operations organizations.
- Delivers key global training programs especially focused on key GxP and quality systems topics.
- Performs training needs assessments and develops actions plans for addressing training needs within the assigned organizations.
- Develops and implements core training curricula for GxP requirements including the annual GxP training plan for the assigned organizations.
- Measures training effectiveness through the reporting of key metricas and the establishment of any department specific training effectiveness measures.
- Leads training risk assessments and compliance gap remediations within the assigned organizations.
- Partners with department leadership to determine training needs and ensure adequate training support.
- Performs data entry and updates in training database for the areas of responsibility as required.
The work of the Sr. Technical Manager, Global 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 Sr. Technical Manager, Global Training is a member of the Associate Director of Global Training’s leadership team and does not have direct reports. The role will need to interact at a Senior Leadership level (director and above) across all TOPs organizations.
BS/MS/B.Sc/M.Sc./PhD preferably in the life sciences.
- 8-10+ years of experience in pharmaceutical or related industry
- 2-4+ 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.
- 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.
This position will interact with all other departments throughout the Technical Operations organization. This position may also partner with Regulatory Affairs, Compliance, WWRD, and other departments as required. This position requires routine contact with Senior and executive management across the organization.
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.