Manager, Deviations Management

2 weeks ago

Holly Springs, United States FUJIFILM Corporation Full time

Overview:

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more importantand we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in peoples lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America. The new site will offer end-to-end solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Check out the FDB Holly Springs Site

External US:

About This Role

The Manager, Deviations Management, is responsible for leading the Resilience team in the classification, investigation, root cause determination, effective Corrective and Preventive Actions creation and on time closure of major and critical investigations.

What Youll Do

During the project phase

Leads, manages, and builds investigations team
Ensures team is trained on the appropriate investigational and root cause tools to ensure readiness for GMP operations.
Transfers the deviation management process from our sister site while building out the investigations team
Administers company policies that directly impact employees.
Completes required administrative tasks (i.e., timecard approvals, time off approvals, expense reports etc.)
Performs other duties, as assigned.

In operations

Manages, leads, develops and mentors team of investigators while overseeing, organizing, and coordinating the tasks of Investigation team
Ensures on-time closure of investigations while also maintaining high quality investigation standards
Serves as the primary manufacturing contact for customers regarding investigation management, specific investigations, and investigation status
Manages and drives continuous improvement by holding investigating team accountable to create effective Corrective and Preventative Actions (CAPA)
Works cross functionally with other managers from the Manufacturing Support team to ensure a team of auxiliary investigators are identified, trained, and maintain competency as investigators in order ensure on-time closure while ensure quality investigations
Maintains resilience and mfg. support compliance metrics and KPIs including on time CAPA closures and effectiveness checks
Acts as investigations lead during regulatory inspections and audits
Fosters an inclusive, people-first culture by creating meaningful development plans with direct reports and conducting 1:1s / skip level 1:1s on a defined cadence
Completes required administrative tasks (i.e., timecard approvals, time off approvals, expense reports etc.)
Performs other duties as assigned

Who You Are

You have the ability to collaborate with manufacturing and other functional areas. You demonstrate strong organizational skills, in addition to project management capabilities. You actively chamption continuous improvement practices and ideas. You have an advanced understanding of good manufacturing practies, inspection requirements, safety and manufacturing operations. You have the ability to coach, by leading and developing individual contributors.

Basic Requirements

High School diploma or GED with 10 years life sciences, pharmaceuticals or regulated industries OR
Bachelors Degree with 6 years life sciences, pharmaceuticals or regulated industries OR
Masters Degree with 4 years of life sciences, pharmaceuticals or regulated industries
Prior experience managing, leading, and developing people
Experience with regulatory inspections, investigations and change management
Prior knowledge and experience various root cause analysis tools
2-3 years of experience leading investigations or an investigations team

Preferred Requirements

6-10 years experience in pharmaceutical / biological manufacturing operations
Previous experience leading others in a pharmaceutical/biological manufacturing facility
Experience working in a changing, project driven organization

Lean certification or similar certifications

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

  • Ability to discern audible cues

WORKING ENVIRONMENT

PHYSICAL DEMANDS

  • Ability to stand for prolonged periods of time - 30 Minutes
  • Ability to sit for prolonged periods of times
  • Ability to conduct work that includes moving objects up to 10 pounds

FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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