Quality Systems Applications Manager – Canon USA – Rockville, MD

Company Overview:
Canon BioMedical, Inc. is a subsidiary of Canon U.S.A., Inc.

Canon U.S.A., Inc., is a leading provider of consumer, business-to-business, and industrial digital imaging solutions to the United States and to Latin America and the Caribbean (excluding Mexico) markets. With approximately $31 billion in global revenue, its parent company, Canon Inc. (NYSE: CAJ), ranks third overall in U.S. patents granted in 2014† and is one of Fortune Magazine’s World’s Most Admired Companies in 2015. In 2014, Canon U.S.A. has received the PCMag.com Readers’ Choice Award for Service and Reliability in the digital camera and printer categories for the 11th consecutive year. Canon U.S.A. is committed to the highest level of customer satisfaction and loyalty, providing 100 percent U.S.-based consumer service and support for all of the products it distributes. Canon U.S.A. is dedicated to its Kyosei philosophy of social and environmental responsibility. In 2014, the Canon Americas Headquarters secured LEED® Gold certification, a recognition for the design, construction, operations and maintenance of high-performance green buildings. To keep apprised of the latest news from Canon U.S.A., sign up for the Company’s RSS news feed by visiting www.usa.canon.com/rss and follow us on Twitter @CanonUSA. For media inquiries, please contact pr@cusa.canon.com.

Canon BioMedical, Inc. is dedicated to extending innovative Canon core technologies into the burgeoning life sciences field — and to the introduction and marketing of vital, new-platform products in the critical area of molecular diagnostics.

† Based on weekly patent counts issued by United States Patent and Trademark Office.

Canon is proud to be an equal opportunity employer. Minority/Female/Individuals with Disabilities/Protected Veterans. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. To read more about employment discrimination protections under federal law, please visit this site: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf

Position Overview:
Canon BioMedical, Inc. is currently seeking a Manager, Quality Systems Application to be responsible for the policies and IT quality oversight of the development, approval and implementation of Computer Systems Validation (CSV) and qualification activities (Quality System Applications, embedded software and Enterprise Systems). Develops and supports custom applications and interfaces for Canon Bio Medical’s needs. The Manager ensures regulatory compliance validation requirements, internal company standards and industry current practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements. The Manager is responsible for team building, capacity planning, project management and systems architecture. The Manager may be responsible for business analysis and 3rd tier support depending on business needs.

Maintain on-going dialog and relationship with Quality and Regulatory teams to identify information technology needs and requirements.

The Manager is responsible for the policies and IT quality oversight of the development, approval, and execution of Computer Systems Validation (CSV) and qualification activities (Quality System Applications, embedded software and Enterprise Systems)

Responsible for compliance to regulations and company procedures pertaining to validation and qualification process and procedures activities.

As the leader of a small collaborative team, this hands-on manager will need to wear many “hats”, including team building, capacity planning, project management, systems architecture, and potentially some business analysis and 3rd tier support, depending on needs and depth of experience they are able to provide.

The Manager leads/guides and supports implementation of process/product improvement projects.

This person will lead a strategic portion of the IT department in a fast-paced environment within a highly innovative, growth-oriented company. It is an exciting role for someone ready to take on big challenges and embrace modern technologies to help drive a business forward.

Education Required:
Bachelor’s degree (or equivalent) in computer science, engineering or related Field

Experience Required:
Knowledge of FDA (e.g. 21CFR820, 21CFR11), ISO, GAMP5, and other applicable cGxP regulations and industry best practices.

Experience in requirements gathering, is required

Demonstrated software validation experience is a plus

7+ years of experience in a regulated industry (Medical Device, Pharmaceutical, etc.) required.

Minimum 5-10 years of Quality IT experience with progressively increasing responsibilities culminating with the management of IT applications and team lead/management.

Ability to mentor and coach all technical roles and analysts

Strong analytical and logical problem solving skills

Ability to define problems, collect data, establish facts, and draw valid conclusions

Owns very high standards of quality

Strong interpersonal communication and relational skills, actively listens to others

Skillfully settles differences by using a win-win approach in order to maintain relationships

Displays attributes that make people glad to follow

Takes charge when the situation demands it

Ability to allocate and balance resource commitments against prioritized business needs

Ability to challenge business requests for proper justification

Ability to forecast future improvements for the systems landscape, with solid architectural vision

Ability to gather requirements and design solutions with stakeholders & end users

Ability to apply regulation and guidance requirements relevant to CSV in a regulated environment

Ability to manage projects with multiple stakeholders, resources, external vendors, etc.

Ability to work alongside team members in a “hands-on” fashion in order to ensure success, which may include tasks like troubleshooting, analyzing requirements, designing solutions, project documentation, presentations, etc.

Excellent communication skills and English proficiency are required

Excellent critical thinking, logic, and troubleshooting skills are required

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