Sr. Manager, QC Technical TrainingLocation Cork, Ireland
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 QC Training is responsible for the implementation of the technical aspects of the QC Training program. This individual is responsible for the identification of the training needs of Quality Control with focus in compliance and technical training. The Technical Manager will give emphasis on the scientific and technical knowledge needed to effectively perform analytical methods.
The incumbent will support the Quality Control organization to deliver and develop department level training and individual training which aligns with the global training strategy and training plan. The incumbent may assist in the administration of the Learning Management System.
- Provides primary technical training support for assigned Quality Control groups.
- Provides key scientific knowledge focused on QC technical areas needed to improve the understanding of methods performed.
- Performs training assessments and develops action plans to address training needs.
- Work in collaboration with Training Administrators to develop and implement core scientific training curricula.
- Leads and/or addresses training risk assessments and compliance gaps within the assigned department.
- Partners with department leadership to determine training needs and ensure adequate training support.
- Delivers training on analytical methods including but not limited to the following:
Compendial methods, UV-Vis, FTIR, SDS, Capillary Electrophoresis, HPLC/UPLC (chromatography and integration), plate-based assays and other analytical methods
- Performs timely and accurate review of training test records
- Supports GMP activities including regulatory agency audits
- Other duties as assigned
The work of the Sr. Technical Manager, Quality Control Training will directly impact product revenue through the development of a flexible and scientifically skilled workforce via the implementation of the technical aspects of the QC training program.
The Sr. Technical Manager, Quality Control Training is a member of the Global QC team. The role will need to interact at all levels within the Quality Control organization.
BS degree in life sciences; MS/PhD preferred
- 5+ years of experience in pharmaceutical or related industry
- Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes. Knowledge of devices, combination products and device development is 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
- In depth knowledge of HPLC is essential. Knowledge in Empower is an advantage
- 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 practices
- Experience in design and facilitation of adult learning (training within the Pharmaceutical Industry preferred)
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.