Associate Director, Program Quality Management

Full-time

FUJIFILM Biotechnologies

Position Overview
The Associate Director (AD), Program Quality Management is responsible for building and sustaining the quality relationship with partners through transparent and trusting communications, working with Program Management and site SLTs to provide unprecedented delivery. This role is accountable for the quality aspects of customer programs from initial discussions through end of program review/close. The Associate Director, Program Quality Management works with customers to define quality requirements and governance for all programs, and agrees the process control strategy for the program, ensuring the right level of quality at the right time and demonstrates adaptability by ensuring processes meet regulatory requirements and support business aspirations (e.g. KojoX). The Associate Director, Program Quality Management works effectively, independently and within a team framework, across all business areas, levels of the organization, and with clients to deliver high quality and ensures timely delivery of QA services. This role operates on both a strategic level with senior executives and facilitates operational elements in actual program execution.
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:
Job Description
What You'll Do
Partners with customers to agree the quality standards/governance/responsibilities for programs, documents and approves Quality Agreements and Statements of Work (SOW) and/or change orders, as necessary.
Manages key product specific documentation, such as process control strategy, product specification and sample plan approvals ensuring the right quality at the right time and aligns the Quality Agreement/SOWs.
Leads, plans, and executes programs in alignment with Quality Agreements.
Acts as Quality point of contact for the Program Management team.
Ensures timely and effective communication between the program client and site quality teams, stakeholders, and applicable functions as necessary with appropriate attendance at site tier/customer project/ customer steering meetings.
Designs strong risk identification and management processes to highlight risk to programs, allowing solutions to be implemented without affecting the ability to deliver.
Drives decisions and recommendations with SLT and/or global quality.
Leads and coordinates client audits in partnership with the PQS team members providing strategic quality support.
Leads Quality Management Review for customer programs ensuring a focus on continuous improvement, identifying trends and risks and agreeing actions with the customer/site.
Ensures delivery of product specification files, annual product reviews, product quality management review and end of campaign reviews. Shares learnings through the organization and across programs.
Provides global PQM representation to customers with programs at multiple sites by working across sites to deliver customer Quality governance.
Partners with the Key Account Manager (KAM) organization to ensure regular feedback and input into relevant customer meetings.
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 within QA and QC such as product-specific stability studies and oversight to the program specific reference material, ensuring requalification's performed and material available for product testing if applicable.
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.
Strong verbal and written communication skills with ability to effectively present information to others.
Excellent organizational and critical thinking skills; problem solving & conflict resolution 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.
Proactive approach to regulatory intelligence and compliance.
Commitment to sustainability and innovative solutions.
Ability to manage multiple assignments while meeting timelines in a GMP environment.
Ability to coach, lead, and develop individual contributors.
Must be flexible to support 24/7 manufacturing facility.
Minimum Qualifications
Bachelor's degree in Life Sciences, Engineering or related science degree and 11+ years' experience in; OR,
Master's degree in Life Sciences, Engineering or related science degree with 9+ years of experience; OR,
D. in in Life Sciences, Engineering or related science degree with 7+ years of experience.
Experience in customer relationship management or alliance management.
Experience in quality assurance in a GMP environment.
Experience in developing and implementing regulatory strategies.
Experience managing projects, programs, or portfolios.
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 60 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 (View email address on us.fitly.work).

Apply

Vacancy posted 4 days ago

Similar jobs that could be interesting for youBased on the Associate Director, Program Quality Management in Holly Springs, NC vacancy

Senior Program Quality Manager (PQM)
...Position Overview The Senior Program Quality Manager is responsible for programs from the point of Quality Agreement signature through program... ...programs and receives coaching & guidance from the Senior Director, Global Program Quality. Company Overview FUJIFILM...
Suggested
Full time
Contract work
Flexible hours
FUJIFILM Biotechnologies
Holly Springs, NC
4 days ago
Associate Director
...Position Overview The Associate Director, QC Biological is responsible for management of multiple labs within the Quality Control department including QC Microbiology. The individuals will act as a representative of QC in cross functional meeting focusing on both startup...
Suggested
Contract work
Temporary work
Shift work
FUJIFILM Holdings America Corporation
Holly Springs, NC
4 days ago
Associate Director
...Associate Director Information Systems – Amgen Join to apply for the Associate Director Technology... ...libraries, and system lifecycle management in alignment with Operations Digital strategy... .... A discretionary annual bonus program, or for field sales representatives, a...
Suggested
Contract work
Remote work
Flexible hours
BioSpace, Inc.
Holly Springs, NC
4 days ago
Associate Director, Drug Product
...manufacturing operation. As Associate Director, Drug Product Manufacturing,... ...manufacturing site committed to quality, safety, and customer... ...staffing plan Establishing and managing budgets During Project... ...resource groups and recognition programs Opportunities to lead...
Suggested
Full time
Temporary work
Flexible hours
FUJIFILM Biotechnologies
Holly Springs, NC
25 days ago
Quality Director - Pool
$149k - $276.7k
...water filtration to industrial water management to pool products and more, our 9,000 global... ....We have an opportunity for a Quality Director to join our Apex, NC team. You will lead... ...Governance & ProgramsOwn and deploy quality programs (Quality Culture initiatives, leading...
Suggested
Permanent employment
Full time
Pentair
Apex, NC
4 days ago
Remote Neurology Associate Medical Director
...Allucent seeks an Associate Medical Director to join our team in a remote-capable role. You will ensure medical/clinical and safety integrity of trials and serve as the medical monitor to investigators and sites, particularly in neurology, with independent oversight and...
Remote job
Jobleads-US
Cary, NC
1 day ago
Senior Program Manager
...Position Overview Program Manager is accountable for the planning & delivery of programs from... ...of the Contract elements (BSA-MSA, Quality Agreement, PPS, SOW). Develop and maintain... ...; identify, escalate & mitigate risks associated with monthly-quarterly-annual financial...
Contract work
Work at office
FUJIFILM Corporation
Holly Springs, NC
5 days ago
Quality Control Manager
...Quality Control ManagerHeadquartered in Conyers, Georgia, Batchelor & Kimball takes pride... ...meet you! We are seeking a Quality Control Manager for our facility in Apex, NC that will... ...support the quality management needs of the program.Establishes metrics to identify trends...
Contract work
For contractors
Work experience placement
For subcontractor
Remote work
Batchelor & Kimball
Apex, NC
5 days ago
Direct Support Program Supervisor
...ResCare Community Living, a part of the Sevita family, provides quality services that empower individuals, enhance independence, and... ...skills, overcome challenges, and reach their full potential. Program Supervisor Are you looking for a career opportunity where you...
Full time
Part time
Work experience placement
Sevita
Apex, NC
10 hours ago
Technical Program Manager
...Technical Program Managers (TPMs) are responsible for overseeing complex technical projects| ensuring alignment with business objectives| and facilitating communication between teams. Project Management| Risk Management| Process Improvement A solid understanding of software...
Permanent employment
Contract work
Local area
Robotics Technologies LLC
Cary, NC
3 days ago
Operations Supervisor
...Company Overview At Liberty Waste Solutions, we're redefining waste management across North Carolina by delivering reliable, safety-focused, and environmentally responsible solutions. Our Apex Transfer Station is a key component of our post-collection network, processing...
Contract work
For contractors
Work at office
Local area
Liberty Waste Solutions
Apex, NC
2 days ago
Director of Revenue Operations- Remote
...Job Description Job Description Director, Revenue Operations Location: Remote - Candidates... ..., automation, integrations, lead management, and revenue processes. Identify operational... ...and holidays ~ Employee Assistance Program (EAP) ~ Optional accident, critical...
Full time
Remote work
MyComputerCareer Inc
Apex, NC
7 days ago
Director of Children, Youth & Families
...Carolina 27526 Full Time , On-Site The Director of Children, Youth, and Family... ...s Church, nursery, and other children's programming. • Select and organize curriculum and teaching... ...appreciation. Administration • Develop and manage ministry budgets. • Maintain attendance...
Full time
Seasonal work
Work at office
Local area
Night shift
Day shift
Afternoon shift
Weekday work
United Methodist Communications
Fuquay Varina, NC
18 days ago
PM Director de Cocina
...El Director de Cocina de Holly Springs es responsable de: · Siempre entregando alimentos apetecibles, de manera oportuna, que cumplan o superen Requisitos de calidad de Chick-fil-A · Entrenar los comportamientos de todos los Entrenadores, Líderes Asistentes, Líderes...
Full time
Local area
Chick-fil-A
Holly Springs, NC
more than 2 months ago
Director
...Vision insurance As the Preschool director at The Learning Experience, you will play... ...administration, operations, and educational programs of a preschool or early childhood... ...ensure smooth day-to-day operations. - Manage administrative tasks, including...
Local area
GSG Holdings
Apex, NC
16 days ago
PM Director de Cocina
...Director of Kitchen The Director of Kitchen at Holly Springs is responsible for: · Always delivering... ...food that meets or exceeds Chick-fil-A quality requirements · Training the behaviors of all Coaches, Assistant Managers, Managers, and Team Members working in the...
Night shift
Weekend work
Chick-fil-A
Holly Springs, NC
4 days ago
Manager, Project and Planning
...people-first approach will drive reliable, compliant production. As Manager, Manufacturing Support, you'll build and lead a talented team,... ..., growth-focused manufacturing organization committed to quality, safety, and operational excellence. Our teams work at the intersection...
Full time
Casual work
FUJIFILM Biotechnologies
Holly Springs, NC
14 days ago
Sr Program Manager, Continuous Monitoring
Senior Program Manager, Continuous Monitoring - Hybrid, Cary, North CarolinaWe’re a leader in data and AI. Through our software and services... ..., consultants, and assessment teams.Oversee the readiness, quality, and timely submission of Continuous Monitoring artifacts, evidence...
Full time
Local area
Work visa
SAS Institute
Cary, NC
10 hours ago
Senior R&D Program Manager
R&D Sr. Program Manager- Hybrid, Cary,NCWe’re a leader in data and AI. Through our software and services, we inspire customers around the... ...project managers, helping improve consistency and execution quality across the program.Support program-level financial planning,...
Full time
Local area
Work visa
SAS Institute
Cary, NC
10 hours ago
Quality Manager
...Quality ManagerSupport all test phase activities during the development lifecycle. Responsible for test plan creation, test execution, documentation, and compliance review. Create and execute manual and automated test scripts. Performing and documenting functional testing...
Syntricate Technologies
Cary, NC
5 days ago
Sr. Program Manager
...Our Mission We aim to be the leading provider of content management software and expertise, helping clients create, manage, publish... ..., and Financial Services. Position Summary The Sr. Program Manager, Professional Services, will be responsible for overseeing...
Full time
Contract work
Temporary work
Work at office
Immediate start
Remote work
Contiem
Cary, NC
3 days ago
Senior Program Manager
$79.24k - $87.16k
...Senior Program Manager The Hunt Institute's mission is to provide unbiased research, technical... ...Manager will report directly to the Director of State Engagement. The position is based... ...-oriented philosophy and personal qualities of trustworthiness, openness, accessibility...
Work at office
Local area
Remote work
Home office
Monday to Friday
Flexible hours
Afternoon shift
3 days per week
The Hunt Institute
Cary, NC
5 days ago
Global Quality Manager
...silicone-coated release liners for the converting industry. We have an exciting opportunity for a Global Quality Manager to join our team. Reporting to the Senior Director of Global Quality, this role provides tactical leadership for Loparex's global quality function,...
Loparex LLC
Cary, NC
10 days ago
DSW Associate Store Manager
...Supports and performs the following functions alongside store management: customer service, merchandising, omni activities and all inventory... ..., fulfillment and store recovery. Participates in monitoring associate compliance to all company policies and procedures, adheres to...
Night shift
Designer Brands
Cary, NC
3 days ago
Director, Regional Operations - Central NC
...Job Description The Regional Director of Operations Central North... ...Operations will oversee the management of all Center Managers in... ...implementation of new processes and programs as sponsored by FastMed... ...: EDUCATION: Minimum of an Associate Degree is required. Bachelor...
FastMed
Fuquay Varina, NC
13 days ago
Marketing Program Manager
$100k - $125k
...focus is in developing new therapies and programs to help transplant healthcare providers... ...Inc.Job Description:The Marketing Program Manager is a strategic execution role within the... ...into action with speed, discipline, and quality. The successful candidate brings strong...
Full time
Work at office
Asahi Kasei
Cary, NC
4 days ago
Operations Manager
We’re looking for an Operations Manager who can wear multiple hats. This is a unique hybrid role combining technical field work, sales... ...as our Lead Technician, managing day-to-day routes and ensuring quality service, while also helping grow the business through sales...
Austin Community College
Holly Springs, NC
4 days ago
Head of Operations
...Head of Operations Senior leadership role Deputy to the General Manager Flexible work arrangements About The Role We are seeking a... ...performance Partner with clinical leaders to ensure safe, high‑quality patient care and service consistency Ensure compliance with...
Flexible hours
Integral Diagnostics (IDX)
Apex, NC
4 days ago
Head of HR Enablement, U.S. Region
...fostering the One Novanta Culture and advancing manager capability, engagement, and scalable... ...this role ensures the delivery of high-quality HR support across the country/region... ...consistent local adoption and application of HR programs, processes, and tools. As an advocate...
Full time
Local area
Novanta
Apex, NC
10 hours ago
Digital Operations Associate, Downstream
...manufacturing. As a Digital Operations Associate, you'll support the tools... ..., Automation, and Quality to keep life-changing therapies... ...detail, organization, and time management; clear written and verbal communication... ...in applicable safety programs and adherence to all site...
Full time
Internship
FUJIFILM Biotechnologies
Holly Springs, NC
19 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Associate Director, Program Quality Management. Be the first to apply!