Manager of Documentation

Description

Tosoh Bioscience, Inc., based in South San Francisco, CA is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists.

Summary

This position is responsible for managing, monitoring, and supporting Document Control, Change Control, and Training personnel based in the Grove City, Ohio office. This position supervises personnel and minimal travel may be required.

Major Duties and Responsibilities

• Document Control Management:
• Develop, implement, and maintain document control policies, procedures, and systems in accordance with GXP regulations.
• Utilize SmartSolve System to manage a centralized electronic document management system (EDMS) for GXP documentation and employee training.
• Ensure proper classification, indexing, version control, and archiving of GXP-related documents.
• Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, ISO, MDSAP)
• Oversee the complete document lifecycle, including creation, review, approval, distribution, training, retrieval, and obsolescence to ensure full compliance.
• Implement and maintain robust quality control measures for GXP documents.
• Conduct regular audits of GXP documents and processes to identify and address discrepancies or noncompliance issues.
• Provide guidance and training to staff on using SmartSolve for document control and compliance purposes.
• Collaborate closely with various departments (Quality, Regulatory, Clinical Affairs, Service, and Marketing, Management, and Technical Operations) to ensure GXP document accuracy and relevance.
• Work in partnership with subject matter experts to collect and update GXP-related information
• Identify opportunities for process improvements in GXP document control practices.
• Implement technological solutions and enhancements, leveraging SmartSolve, to streamline GXP document management and compliance
• Identify and mitigate risks associated with GXP document control processes.
• Develop contingency plans for document retrieval and recovery in case of system failures or emergencies.

Education

• Bachelor of Science or Medical Technology or equivalent combined work experience.

Skills and Qualifications

Bachelor’s degree or higher in a relevant field (e.g., biology, chemistry, pharmaceutical sciences).

• Substantial experience (10 years) in document control or quality assurance within the medical device biotechnology or pharmaceutical industry, with a strong focus on GXP regulations.
• Proficiency in utilizing electronic systems for document management, training, and compliance.
• Thorough knowledge of GXP regulatory requirements and quality standards
• Exceptional organizational, communication, and problem-solving skills
• Attention to detail and a commitment to maintaining accuracy and compliance.
• Ability to work in a fast-paced and nimble environment with a rapidly growing organization
• Strong leadership skills and the ability to collaborate and work effectively with cross-functional teams
• Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Excellent communication skills with an ability to present to a variety of stakeholders and tailor message accordingly.
• Commitment to growing you professionally and providing access to resources to further your development.
• Knowledge of Tosoh instrumentation a plus.
• Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.

Physical Requirements

• The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Must be able to travel by auto and air, including international. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working Conditions

• This position requires visits to customer sites which are medical facilities. These facilities may have certain requirements which TOSOH representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings.
• Must agree to provide required immunization records or agree to acquire required immunizations to gain access to customer sites, as required by, customers. You may be required to register at vendor credentialing companies.

Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans

Qualifications