Manager, Deviations Management (DPFG)

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 important—and 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 people’s 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 solutions to 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 You’ll 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• Bachelor’s Degree with 6 years life sciences, pharmaceuticals or regulated industries OR• Master’s 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