Vice President of Commissioning, Qualification and Operational Readiness Position Available In Durham, North Carolina

Vice President of Commissioning, Qualification and Operational Readiness
Job Locations
US-NC-Durham
Posted Date
3 days ago
(6/18/2025 7:54 PM)
Requisition

ID 2025-34734

Category Management Company (Portal Searching) Diosynth Biotechnologies
Position The work we do at Biotechnologies (FB) has never been more important and we are looking for talented candidates to join us. We’re growing our capabilities and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharmapanies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive. This is what FB calls Genki. Join us and discover amunity that thrives on diversity and never scares away from aplex challenge. Take the opportunity to work with some of the most dedicated scientists, engineers, and manufacturers in the industry. At FB, you determine what’s possible. Company The work we do at Diosynth Biotechnologies has never been more important—and 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 people’s lives. Join Diosynth Biotechnologies and help make the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharmapanies 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 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.”

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fujifilmus/en/about/region/careers Job 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 oues andpliance 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 andpliant 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 FDB’s 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,pliance, 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 theanization.

Program Development & Execution:

 Develop and implementprehensive Commissioning and Qualification plans and protocols for new and existing facilities, ensuringpliance 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, andpliance.

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 andpliance.

Regulatory Compliance & Risk Management:

 Oversee the preparation and review of validation documentation and conduct risk assessments to ensurepliance and mitigate potential issues.

Audit Facilitation & Communication:

 Prepare for and manage internal and external audits related to C&Q, maintaining clearmunication with stakeholders and regulatory bodies.

Industry Outreach & Participation:

Engage in industry outreach, including participation in industry standards development, professional societies, and STEM mentorship, promoting theanization’s 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 fullypliant and perform consistently to achieve thepany’s quality standards.
Accountable for function financial results which impactanization performance. Qualifications and Experience Bachelor’s 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 drivenanisation
P&L oversight/responsibility
change management / large transformations or green field environment
Outstandinganizational and leadership abilities Influence and Decision Making This role significantly impacts operational efficiency, product quality, and regulatorypliance, directly influencing thepany’s ability to meet its production and market goals effectively and without interruption.
Oversees team(s) to develop new methods and solvepany-wide matters.
Interacts with internal and external executive level management, requiring negotiation of extremely critical matters Influences policymaking and strategy based onmunication strategies and persuasion skills. Partners with executive leadership team for the function to provide cohesive direction towardspany 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 regulatorypliance.
Develops and provides strategy, vision and direction to multiple functions.
Implementspany wide policies and practices. Provides input to executive management.
Anticipates factors that could influence strategies andpany position in the market.
Establishes and develops broaderpany strategy and translates into multi-functional objectives.
Erroneous decisions will effect thepany’s 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 andmunication skills for managing project teams and stakeholder relationships.
Proficiency in project controls software and integration with corporate systems.
Ability to analyzeplex data sets and provide actionable insights and forecasts.
Familiarity with risk management and change control processes.
Recognized as an industry expert.
Outstandinganizational and leadership abilities
EEO Information Fujifilm ismitted to providing equal opportunities in hiring, promotion and advancement,pensation, 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 amodation inpleting this application, interviewing,pleting any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (fdbglobaltalentfujifilm). Options