Principal Quality Officer Position Available In Wake, North Carolina

Job Description:

Position OverviewThe Principal Quality Officer, (FUJIFILM LifeSciences) FFLS Corporate Quality Office is proactive senior levelposition designed to provide proactive compliance oversight throughadvisory audits, data-driven insights, and collaborative support at

FUJIFILM

Life Sciences platform level.

By fostering transparency,learning, and risk awareness, the FFLS Corporate Quality Officeassists FFLS companies turn audits into opportunities for growthwhile maintaining consistency, accountability, and regulatoryexcellence across the organization.

Company OverviewThe work we doat

FUJIFILM

Diosynth Biotechnologies has never been moreimportant-and we are looking for talented candidates to join us.

We’re growing our locations, our capabilities, and our teams, andlooking for passionate, mission-driven people like you who want tomake a real difference in people’s lives. We’re proud to cultivatea culture that will fuel your passion, energy, and drive what

FUJIFILM

Diosynth Biotechnologies calls Genki. Join us and discovera community that thrives on diversity and never scares away from acomplex challenge. At

FUJIFILM

Diosynth Biotechnologies, youdetermine what’s possible.

Job DescriptionPrincipalAccountabilities:

Auditing:

Prepare and conduct FFLS Group Quality Audits (e.g.as a proactive tool for integrating new companies/sites; supportingthose without recent Third Party Audits; and addressing sitesexceeding agreed action limits).

Auditing:

Peer-review colleagues’ audit reporting.

Auditing:

Support companies/sites with consultative auditsbuilding understanding of compliance requirements and bestpractices through training as needed.

Quality Oversight:

Collect and analyze compliance data creatingthe bi-annual Quality Health Oversight Report providing seniorleadership with a structured compliance status overview.

Quality Oversight:

Analyze Third Party Audit/Inspectionoutcomes to provide a comprehensive overview of compliance trends,recurring challenges and potential risks across FFLScompanies.

Strategic Insights:

Offer strategic recommendations and assistin identifying process improvement opportunities and innovativesolutions. Engage in high-level strategic discussions to drivecontinuous improvement initiatives. Independent reviewer andauthority responses and corrective actions as applicable, ensuringalignment with compliance expectations.

Information Management & Presentation Development:

Synthesizeinformation to support briefings and presentations. Transformcomplex data into impactful presentations for various audiences,including executive leadership and cross-functional teams. Conveykey messages and strategic initiatives effectively.

Effective Communication:

Ensure translation of FFLS CorporateQuality vision and goals into actionable directives. Facilitateteam alignment by maintaining clear and efficient communicationchannels.

Interpersonal Skills:

Foster strong working relationshipsacross all organizational levels. Collaborate with teams andstakeholders to drive alignment, foster teamwork and motivate theorganization.

Independent Work:

Operate autonomously, taking ownership oftasks and projects. Execute initiatives with minimal guidance,making informed decisions. All other duties as assigned.

Minimum Education and ExperienceRequired:

Master’s degree in Natural Sciences, Life Sciences or similarwith 12+ years within GxP from the biotech/pharmaceutical industryand extensive knowledge of relevant regulatory requirements OR 15+years experience within GxP from the biotech/pharmaceuticalindustry and extensive knowledge of relevant regulatoryenvironments. Minimum of 5 years as an Experienced GxP Lead Auditor Excellent understanding of business, value chain, andpharmaceutical industry as well as strong stakeholder andcollaboration skills in a multinational context.

Knowledge, Skillsand Abilities:

Exceptional communication skills, both written and verbal, withthe ability to convey complex ideas clearly and concisely. Fluency (verbal and written) in English Strong presentation skills, capable of engaging and influencingdiverse audiences. Excellent interpersonal skills and ability to collaborateeffectively with cross-functional teams. Understands the importance of involving stakeholders in dailywork and interact effectively with senior management. Ability to identify risk areas, manage time effectively, andreach conclusions while being flexible and adaptable tochange. Strong analytical skills with an eye for detail combined withthe ability to extract and apply into a tactical and strategiccontext. Self-motivated and able to work independently with minimalsupervision. Professionalism, tact, and discretion in handling confidentialmatters.

The salary range for this US remote role is $187,000 to$294,000/yr. dependent on a number of factors including but notlimited to experience and geographic location.

To all agencies:

Please, no phone calls or emails to any employee of

FUJIFILM

aboutthis requisition. All resumes submitted by search firms/employmentagencies to any employee at

FUJIFILM

via-email, the internet or inany form and/or method will be deemed the sole property ofFUJIFILM, unless such search firms/employment agencies were engagedby

FUJIFILM

for this requisition and a valid agreement with

FUJIFILM

is in place. In the event a candidate who was submittedoutside of the

FUJIFILM

agency engagement process is hired, no feeor payment of any kind will be paid.

EEO InformationFujifilm iscommittedto providing equal opportunities in hiring, promotion andadvancement, compensation, benefits, and training regardless ofnationality, age, gender, sexual orientation or gender identity,race, ethnicity, religion, political creed, ideology, national, orsocial origin, disability, veteran status, etc.

ADA InformationIfyou require reasonable accommodation in completing thisapplication, interviewing, completing any pre-employment testing,or otherwise participating in the employee selection process,please direct your inquiries to our HR Department(fdbglobaltalent@fujifilm.com). #J-18808-Ljbffr