QA Program Manager

Fujifilm

Posted on : 13-06-2025

Employer Active

1 Vacancy

Job Alert

You will be updated with latest job alerts via email

Valid email field required

Send jobs

Send me jobs like this

Job Alert

You will be updated with latest job alerts via email

Valid email field required

Send jobs

Job Location

College Station, TX - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 13-06-2025

Job Description

Position Overview

Summary: The Quality Assurance Program Quality Manager (QA PQM) is responsible for the operational oversight and execution of program quality requirements from the point of Quality Agreement signature through program closure. This role acts as the primary Quality liaison for assigned client programs ensuring that program deliverables align with contractual commitments quality standards and regulatory requirements. Working in close collaboration with cross-functional teams the Program Quality Manager helps ensure successful program outcomes through detailed coordination compliance monitoring and proactive issue resolution.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more importantand we are looking for passionate mission-driven people like you who want to make a real difference in peoples lives.

From developing the next vaccine to advancing cell and gene therapies we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If youre ready to help transform the future of medicine join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and were proud to cultivate a culture that will fuel your passion energy and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located in in College Station Texas which combines a small-town feel with vibrant culture top-notch schools and close proximity to big city life. Nestled between major hubs its a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70000 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

Essential Functions for QA PQM I:

The major responsibilities/essential functions of this position including significant tasks responsibilities projects etc. in order of importance or impact include but are not limited to:

Will handle an average of one (1) or two (2) customer programs of minimal complexity and scope.
Serve as the primary Quality contact for assigned clients and programs participating as a core project team member to represent Quality interests throughout the program lifecycle.
Will assist and facilitate the planning and delivery of program quality activities per approved Quality Agreements and ensure compliance with FDA EU and other relevant regulatory bodies.
Work with functional areas after initial Scope of Work (SOW) is drafted to ensure all requirements within the quality agreement are achievable documented and aligned with business objectives.
Coordinate and track completion of contract elements within the Quality Agreement supporting timely and accurate delivery of commitments.
Communicate with the Project Manager and other stakeholders regarding requests or changes that impact quality requirements including initiating change control processes if necessary.
Support and participate in internal and client-facing program kickoff meetings providing education on key elements and deliverables.
Assist in organizing and running Quality project team meetings preparing agendas distributing meeting notes and maintaining an action and risk log.
Assign and follow up on quality-related tasks and accountabilities across the program team.
Monitor and communicate program quality performance risks and issues; escalate unresolved concerns to functional leaders when appropriate.
Support Quality review and approval of technical documentation such as product specifications and validation protocols.
Help prepare for and participate in client audits in collaboration with Quality team members.
Perform other duties as required to support departmental and business objectives.

Additional Essential Functions for QA PQM II

Will handle two (2) to four (4) customer programs of relatively moderate complexity and scope.
May assist in training of junior team members.
Serve as the primary Quality contact for assigned clients and programs participating as a core project team member to represent Quality interests throughout the program lifecycle.
Coordinate New Product Introduction (NPI) assessments with stakeholders.
Perform other duties as required to support departmental and business objectives.

Required Skills & Abilities:

Collaborative work style and ability to operate effectively within cross-functional teams.
Strong organizational skills attention to detail and ability to manage multiple assignments in a deadline-driven GMP environment.
Assess unusual circumstances and use sophisticated analytical and problem-solving techniques to identify the cause.
Excellent verbal and written communication skills in English.
Deliver timely responses and updates to clients on program quality activities including deviations change management and product disposition.
Resolve and assess a wide range of issues in creative ways and suggest variations in approach.
Receives minimal supervision for routine tasks and general directions only for new assignments.
Familiarity with regulatory standards including cGMP FDA EU and risk management practices.
Effectively adapts communication style for different audiences and frequently provides guidance to others on complex issues.
Enhance and strengthen relationships and networks with senior internal and external partners even when they are not familiar with the subject matter and may require persuasion.
Handles problems of varying complexity where analyzing information requires evaluating clearly defined factors.
Applies evaluation judgment and interpretation to determine the most appropriate course of action.
Works independently with review occurring at key milestones.
Develops solutions using limited data and precedents and modifies existing methods to address challenges.
Proactive problem-solving and conflict resolution skills.
Ability to work in office and manufacturing areas.
Ability to navigate complex and evolving program requirements and stakeholder expectations.
Experience with quality management systems documentation and tracking tools.

Working Conditions & Physical Requirements:

May require prolonged periods of sitting or standing.
Regular use of hands for computer work and documentation.
May require lifting up to 10 lbs.
Must be flexible to support a 24/7 manufacturing operation as needed.

Note: This job description outlines general duties and requirements and may be adjusted based on business needs. The Program Quality Manager (Level I/II) will not have direct or indirect personnel reports but will be responsible for leading program-specific quality activities through coordination and influence.

Basic Qualifications for QA PQM I:

Bachelors in Life Sciences Chemistry or Engineering or equivalent with 2 years of applicable industry experience.
Prior customer relationship management experience/project management experience.

Basic Qualifications for QA PQM II:

Bachelors in Life Sciences Chemistry or Engineering or equivalent with 4 years of applicable industry experience OR
Masters in Life Sciences Chemistry or Engineering and 2 years of applicable experience OR
PhD in Life Sciences Chemistry or Engineering and 1 years of applicable experience.
3 years of project management experience.
2 years experience in customer relationship management.

Preferred Qualifications:

Prior project management experience in industry or related.
Prior customer relationship experience in industry or related.
Additional certifications in project management (e.g. PMP) or Quality Management (e.g. Six Sigma ASQ CQE) are an advantage.
Training or experience in Quality Risk Management principles.
Prior drug substance or manufacturing experience including process validation transfer commercialization and manufacturing support and troubleshooting.

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 pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ( or ).

Required Experience:

Manager

Employment Type

Unclear

Company Industry

Key Skills

Apply Now

About Company

Fujifilm

Report This Job

Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.

Start Now

Dr.Job AutoApply

3X your job search with AutoApply's AI for faster dream job results.

QA Program Manager

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

Similar Jobs

Lead QA Engineer F/H/X

Business Development Manager

Account Manager (Fintech)

Account Manager (Fintech)

Senior Client Success Manager

Sales Manager with Spanish

Clinical Site Relationship Manager

Clinical Site Relationship Manager