Vice President of Commissioning, Qualification and Operational Readiness

Fujifilm

Posted on : 21-06-2025

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1 Vacancy

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Job Location

Durham - USA

Monthly Salary

Not Disclosed

Salary Not Disclosed

Vacancy

1 Vacancy

Posted on : 21-06-2025

Job Description

Position Overview

The work we do at FUJIFILM Biotechnologies (FB) has never been more important and we are looking for talented candidates to join us. Were growing our capabilities and looking for passionate mission-driven people like you who want to make a real difference in peoples lives. Join FB and help create the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here youll work alongside and learn from some of the most dedicated scientists engineers and manufacturers in the industry. Were proud to cultivate a culture that will fuel your passion energy and drive. This is what FB calls Genki.

Join us and discover a community that thrives on diversity and never scares away from a complex challenge. Take the opportunity to work with some of the most dedicated scientists engineers and manufacturers in the industry. At FB you determine whats possible.

Company Overview

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 mission-driven people like you who want to make a real difference in peoples lives.

Join FUJIFILM Diosynth Biotechnologies and help make 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.

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

The Vice President of Commissioning Qualification and Operational Readiness is responsible for the strategic leadership and management of Commissioning Qualification and Ops Readiness and Ops Readiness (C&Q/OR) activities across FDB including the design and implementation of a global harmonized C&Q/OR program across all FB GMP manufacturing facilities. The role will work closely with global and site stakeholders in Quality Engineering MSAT Operations Automation IT and other departments to develop implement and manage global C&Q/OR standards and procedures designed to ensure facilities utilities and equipment used for GMP production are fit for purpose and operate in a state of control. Utilizing a risk-based qualification strategy aligned with industry guidance the position ensures quality outcomes and compliance with health regulations to support the efficient and safe production of a diverse array of biopharmaceutical products.

The role will provide active oversight of C&Q/OR activities for large capital projects to ensure timely project delivery and compliant implementation of the global C&Q/OR program as well as engaging site teams to ensure GMP facilities utilities and equipment are maintained in a state of control. The role will serve as the system owner for FDBs electronic validation lifecycle management system.

The Vice President of Commissioning Qualification and Ops Readiness reports to the Global Head of Engineering and works closely with cross-functional teams to develop strategies that align with business goals ensuring safety compliance and continuous improvement. The role will have up to three direct reports up to eight indirect reports and reports directly to the SVP Global Expansions who is part of the Executive Leadership Team.

Key Responsibilities

Develop Global Standards:Develop implement and maintain global Commissioning and Qualification (C&Q) standards and procedures to ensure consistent application across the organization.
Program Development & Execution:Develop and implement comprehensive Commissioning and Qualification plans and protocols for new and existing facilities ensuring compliance with industry standards and regulatory requirements.
Align CQ/Ops Readiness Practices:Align CQ/Ops Readiness practices across the FDB Network to maintain uniformity and harmonization ensuring all sites operate under the same high standards.
Continuous Improvement Initiatives:Promote continuous improvement in C&Q performance through initiatives that enhance efficiency effectiveness and compliance.
Best Practices & Lessons Learned:Facilitate the sharing of best practices and lessons learned within the C&Q network to drive improvements and innovation.
C&Q Workforce Development:Focus on developing the C&Q workforce through education training and professional development opportunities to enhance skills and capabilities.
Collaboration & Integration:Work closely with Engineering Quality Assurance and Operations teams to integrate validation processes into project workflows ensuring seamless execution and compliance.
Regulatory Compliance & Risk Management:Oversee the preparation and review of validation documentation and conduct risk assessments to ensure compliance and mitigate potential issues.
Audit Facilitation & Communication:Prepare for and manage internal and external audits related to C&Q maintaining clear communication with stakeholders and regulatory bodies.
Industry Outreach & Participation: Engage in industry outreach including participation in industry standards development professional societies and STEM mentorship promoting the organizations presence and influence
And other job duties that may be assigned from time to time.
The Vice President of Commissioning Qualification and Operational Readiness is accountable for developing and executing strategies that ensure equipment and processes are fully compliant and perform consistently to achieve the companys quality standards.
Accountable for function financial results which impact organization performance.

Qualifications and Experience

Bachelors degree in Engineering Life Sciences or a related field is required.
An advanced degree or relevant certification in quality assurance or validation is preferred.
Minimum of 15 years of experience in C&Q with at least 5 years in a C&Q leadership role. Preference for experience in a global C&Q leadership role responsible for a multi-site C&Q program and oversight of C&Q for large capital projects.
Advanced technical knowledge and experience in the facilities utilities and equipment used in the production of biopharmaceutical intermediates and products including both large-scale stainless steel plants as well as plants using single use technology equipment.
Advanced technical knowledge and experience in the implementation of pharmaceutical regulations and industry standards including CFRs EudraLex ASTM E2500 ISPE Baseline Guide 5 etc.
Experience working in a changing project driven organisation
P&L oversight/responsibility
change management / large transformations or green field environment
Outstanding organizational and leadership abilities

Influence and Decision Making

This role significantly impacts operational efficiency product quality and regulatory compliance directly influencing the companys ability to meet its production and market goals effectively and without interruption.
Oversees team(s) to develop new methods and solve company-wide matters.
Interacts with internal and external executive level management requiring negotiation of extremely critical matters Influences policymaking and strategy based on communication strategies and persuasion skills. Partners with executive leadership team for the function to provide cohesive direction towards company goals.
Recognized as an influential leader.
Leads activities of one or more functional areas divisions product groups and services through subordinate directors / managers who have overall responsibility for the successful operation of assigned areas.
The position requires making critical decisions related to the validation processes including problem-solving resource allocation and ensuring regulatory compliance.
Develops and provides strategy vision and direction to multiple functions.
Implements company wide policies and practices. Provides input to executive management.
Anticipates factors that could influence strategies and company position in the market.
Establishes and develops broader company strategy and translates into multi-functional objectives.
Erroneous decisions will effect the companys success five years or longer.

Key Skills

Expert knowledge of C&Q processes and requirements particularly in regulated industries.
Strong analytical and problem-solving skills with a focus on preventive and corrective actions.
Proficiency in validation documentation and regulatory standards (e.g. FDA EMA).
Familiarity with continuous improvement methodologies and tools.
Strong leadership and communication skills for managing project teams and stakeholder relationships.
Proficiency in project controls software and integration with corporate systems.
Ability to analyze complex data sets and provide actionable insights and forecasts.
Familiarity with risk management and change control processes.
Recognized as an industry expert.
Outstanding organizational and leadership abilities

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 ().

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About Company

Fujifilm

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Vice President of Commissioning, Qualification and Operational Readiness

Fujifilm

Job Description

Position Overview

Company Overview

EEO Information

ADA Information

Employment Type

Company Industry

Key Skills

About Company

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