About this opportunity
Merck & Co. lists this Strategic Quality Programs Lead opportunity in holly springs, North Carolina. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Position Overview
The Senior Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program closure. This role ensures Fujifilm Biotechnologies, Holly Springs 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 FUJIFILM Biotechnologies, Holly Springs Quality. The Senior Program Quality Manager handles an average load of 1-3 programs and receives coaching & guidance from the Senior Director, Global Program Quality.
Company Overview
FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.
We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!
Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.
Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit: Description
What You'll Do
Acts as Primary Quality liaison and project team member between the client and FUJIFILM Biotechnologies, Holly Springs.
Leads the planning and execution of programs in alignment with Quality Agreements (vision, mission, strategy-goals-objectives).
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 cross-functional 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, action-risk 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 issues-risks-decisions 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 high-level documents, including, process control strategy, product specification, and PPQ protocols/reports.
Performs other duties, as assigned.
Knowledge, Skills, and Abilities
Collaborative attitude with the willingness to work with global peers and cross-functional teams toward company and department goals.
Excellent oral and written communications skills and fluency in English.
Excellent organizational and critical thinking skills.
Attention to detail and commitment to maintaining the quality standards.
Strong understanding of regulatory affairs in biopharmaceutical manufacturing.
Ability to navigate complex stakeholder interactions.
Knowledge of Project Management principles.
Proactive approach to regulatory intelligence and compliance.
Commitment to sustainability and innovative solutions.
Problem solving & conflict resolution.
Ability to manage multiple assignments while meeting timelines in a GMP environment.
Must be flexible to support 24/7 manufacturing facility.
Minimum Qualifications
Bachelor's 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 Qualifications
Training and/or familiarity with Quality Risk Management principles project management training.
Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:
Ability to discern audible cues.
Ability to stand for prolonged periods of time for up to 30 minutes.
Ability to sit for prolonged periods of time for up to 120 minutes.
Ability 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 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.
*LI-Onsite
EEO Information
Fujifilm is committed to 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 pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ( ).
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Worksite address
holly springs, NC, 27540, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.