Sr. Manager, Quality Control (Microbiology)

Overview

The Sr. Manager, Quality Control (Microbiology) is responsible for the effective management of the Quality Control Microbiology team to assure on time analysis of manufactured product and environmental monitoring samples.  Responsible to assure all testing is performed in compliance with applicable regulations, company specifications, procedures, and policies at Fujifilm Diosynth Biotechnologies.

 

The Sr. Manager, Quality Control (Microbiology) is the site SME for Microbiology, with oversight of microbial and environmental control in the manufacturing facility. The roles plays a key partnership with manufacturing operations through trend identification, best practice establishment and continual improvement of operations.

 

The Sr. Manager, Quality Control (Microbiology) is key to creating an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross-functionally to deliver exceptional results and ensure long-term business success. This role is essential to the success of the wider QC function, working in collaboration with peers to deliver the wider QC strategic plan.

External US

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Main areas of responsibility include, but are not limited to:

• Creates a safe working environment within QC through a culture of behavioral safety and adherence to site EHS policies and procedures.
• Ensures team are actively engaged in the on-time delivery of routine operations and annual objectives.
• Maintains the QC Laboratories in a state of audit readiness, presents on QC topics and leads tours for client and regulatory inspections.
• Manages the team for excellence in laboratory investigations, on time completion of CAPA and Change Control.
• Assures appropriate team training requirements are established and compliance to assigned curricula.
• Oversight of microbial and environmental control in the manufacturing facility.
• Champion for Continuous Improvement providing the resources and developing the team to evaluate and improve upon current state.
• Invested in the development and actively manages performance of individuals.
• Adherence to QC expense and capital budget

ORGANIZATIONAL STRUCTURE:

This position reports to the Head of Quality Control. The role has 10-15 direct reports including supervisor and individual contributors.

SCOPE MEASURES:

The Sr. Manager, Quality Control (Microbiology) may supervise 10 or more exempt or non-exempt staff. They contribute to the development of the capital and expense budget and have approval authorities as defined in the company's authorization matrix. They are responsible for managing the department activities in a manner that meets or exceeds the company objectives regarding revenue, profit plan, supply, and compliance.

BACKGROUND REQUIREMENTS:

Minimum Education Requirements

BSc, in Microbiology or related technical field

 

Desired Experience

10+ years related experience (6 years required with relevant MS or PhD degree) in GMP laboratory environment including 5 years supervisory experience

Knowledge and experience of Bioburden, endotoxin and EM testing

Experience working in a lean manufacturing or six sigma environments

Experience with LIMS and other data management systems

 

Specific Skills and Competencies

• Demonstrated leadership, technical aptitude, and problem-solving skills
• Must be flexible and able to manage and prioritize multiple tasks and assignments.
• The individual must have excellent verbal and written communication skills and comfortably and clearly articulate issues with peers and colleagues at all levels in the organization.
• Demonstrated capability in a cross-functional team environment, working cooperatively with others in effective ways that attain goals while encouraging teamwork and synergies throughout the organization
• Capable of high through-put and high quality, RFT work
• Proficient technical writing skills
• Able to make informed and timely decisions independently
• Capable of recognizing process gaps and implementing improvements
• Demonstrated leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
• Strong team skills, including the ability to coach/develop work teams, provide training, motivate/empower others, and resolve
• Must be goal-oriented and able to manage risks

 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that