Sr Program Quality Manager
Sr Program Quality Manager
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Overview
The Sr. Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Diosynth Biotechnologies Holly Springs (FDBN) provides services in alignment with our contracted commitment to clients and our company vision/mission (strategy and compliance). This role is the primary client liaison representing FDBN Quality. The Sr. Program Quality Manager handles an average load of 13 programs and receives coaching & guidance from the Senior Director Global Program Quality.
Company Overview
Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO
The work we do at FUJIFILM Diosynth Biotechnologies 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 missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies 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 newlargescale 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 endtoend cell culture CDMO provider in North America.
The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.
Job Description
What Youll Do
Acts as Primary Quality liaison and project team member between the client and FDBN
Leads the planning and of programs in alignment with Quality Agreements (vision mission strategygoalsobjectives)
After the Sales Team completes the initial draft Scope of Work (SOW) engages impacted functional areas for inputs to ensure the quality agreement elements are complete and realistic
Ensures that the quality agreement is organized based on segments of work and regulatory requirements including FDA EU and other regulatory agencies
Coordinates and monitors completion of the contract elements of the Quality Agreement
Understands the approach and details of the SOW and communicates to the Project PM any work requested beyond the quality agreement/contract that is covered by change orders
Acts as Subject Matter Expert (SME) and provides strategic support for client audits in partnership with the PQS team members
Participates in crossfunctional Program Kickoffs (Internal & Client)
Educates the impacted organization about the key elements/deliverables of the Quality Agreement
Represents Quality on the project team & steering committee membership as needed
Organizes leads and facilitates Quality project teams (internal and external) and determines meeting cadence for each program
Provides a standard agenda and meeting summaries such as discussion points decisions actionrisk log. Implements a project team meeting cadence which enables appropriate internal discussions and client engagement/communication
Assigns and tracks specific functional accountabilities
Actively conducts risk management within and across programs. Escalates unresolved issuesrisksdecisions to functional leaders and/or tier process as appropriate to ensure that SLT knows the impact and potential intervention needed for resolution of potential Quality issues
Tracks and reports programs quality performance through periodic Management Review
Provides timely responses to clients including but not limited to communications involving deviations change management product disposition and all other quality agreement deliverables
Performs Quality approval of highlevel documents including process control strategy product specification and PPQ protocols/reports
Performs other duties as assigned
Minimum Requirements
Bachelors in Life Sciences or Engineering or equivalent with 8 years of applicable industry experience OR
Masters in Life Sciences or Engineering and 6 years of applicable experience OR
PhD in Life Sciences or Engineering and 4 years of applicable experience
Experience in customer relationship management or alliance management
Experience in quality assurance in a GMP environment
Experience in developing and implementing regulatory strategies
Preferred Requirements
Training and/or familiarity with Quality Risk Management principles
Project management training
Working & Physical Conditions
Ability to discern audible cues.
Ability to ascend or descend ladders scaffolding ramps etc.
Ability to stand for prolonged periods of time up to 60 minutes.
Ability to sit for prolonged periods of time up to 120 minutes.
ity to conduct work that includes moving objects up to 10 pounds.
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 viaemail 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.
EEO Information
Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.
ADA Information
If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .
Required Experience:
Manager
Employment Type
Unclear
