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Overview

The Senior Director Global Quality Assurance, Audits & Inspections will be responsible for audit/CAPA activity timeline management, review of proposed audit observation/CAPA responses and proposed actions as well as Quality support across various functions. The incumbent will be responsible for contributing to the development and implementation of the global strategy and policy relative to quality management systems for FUJIFILM Diosynth Biotechnologies (FDB) to ensure excellence in compliance and the ability to withstand internal and external scrutiny. The incumbent will ensure that internal audit controls are implemented and are evaluated for compliance through audits and assessments across the FDB functions to minimize regulatory, legal, and business risk while effectively and efficiently supporting business goals. The incumbent will be responsible for leading the audits and inspection aspects of the Quality Systems and ensure compliance with company’s procedures, company policies, and regulatory guidelines. The role will be responsible for crafting, implementing, and driving an innovative corporate audit and inspection program. The individual will be sought out as the audit and inspection authority and will lead teams of quality professionals to ensure quality and compliance adherence to corporate audit and inspection program.

External US

At FUJIFILM Diosynth Biotechnologies, an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Hereyou willhavethe chance to learn from some of the most dedicated scientists, engineers, and manufacturers who are deeply committed to making an impact on people’s lives.We aredifferent.We strive for better. Our people never settle for the status quo and as you push the boundaries of your potential, you not only change your life,youchange others’ too. Our globalteam are looking for someone who shares our passion, drive, and energy – what we call Genki. Join us as our Senior Director Global QA, Audits and Inspections, and commit your life’s work to impacting where it matters most:human lives.

FUJIFILM Diosynth Biotechnologies (FDB) is transforming the customer experience – using trust as the cornerstone of our effort. Our Partners for Life Strategy lays out the direction for us to be the leading and most trusted CDMO in the biopharmaceutical industry. To further enable this strategy, we are looking for a Senior Director, Global Quality Assurance Systems, Audits and Inspections to join our Global QA Systems Leadership Team that oversees GxP activities at FDB. In this role you will be responsible for providing global strategic direction and leadership for the Global Quality audit program to assure compliance with regulatory requirements across FDB as well as supporting the continuous improvements of the FDB Quality Systems. You will have accountability for the audit program, assuring independent oversight, effectiveness in delivery on objectives and a strong quality voice. Advanced leadership skills and a partnership mindset, anchored by expert knowledge of the regulations governing preclinical research, drug development and post marketing activities (i.e., GCP, GLP/GCLP, and GMP), as well as a keen understanding of process controls will enable success in this role. This role will work closely with internal QA leads/stakeholders and external suppliers to assist in the planning, scheduling, conducting, and leading all aspects of GxP audits. They will collaborate internally and externally with internal manufacturing sites as well as Contract Service Providers (CSPs) for activities in compliance in Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing (GMP).

Main Activities and Responsibilities:

• Develop risk-based corporate audit strategy.

• Supervising activities related to inspection readiness, hosting and coordinating GxP inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.

• Developing, maintaining and ensuring the execution of a risk-based, proactive GxP Inspection Strategy

• Ensure the development of inspection risk-analyses and risk-mitigation plans and communicating to relevant cross-functional and Quality Leadership

• Supervising/Managing the collaboration with cross-functional internal and external partners to ensure a unified, optimal inspection strategy.

• Ensure the development, revision and maintenance of optimal tools, processes and procedures for inspection readiness, coordination and management.

• Ensure the creation and execution of the GxP Inspection Strategy

• Lead a team of Quality professionals and/ or consultants to carry out all defined GxP Inspection Readiness, Management and Hosting activities

• Collaborate with relevant cross-functional leaders to ensure a unified, optimal Inspection Readiness (IR) strategy

• Oversee (pro-actively) the adequate and timely fulfillment of all inspection commitments, timely communication with Inspectorates/Health Authorities, including responding to inspection findings and submission of inspection dossiers and pre-inspection requests and resolve any issue for timely and adequate closure of CAPAs.

• Maintain an up-to-date inspection forecast and inspection outcome tracker

• Ensure the provision of lessons learned sessions after inspections, identifying trends and best practices to implement process improvements.

• Chair quarterly Cross-functional Inspection Oversight Committee (IOC) meetings

• Guide and / or manage the creation/revision of relevant procedures

• Manage / review trends and report significant investigation / deviation issues and system deficiencies to senior management, as appropriate

• Manage internal auditor training program and coordinate and / or administered GxP audit training, as needed

• Participate and represent Quality in meetings and discussions, as needed

• Act as Quality Delegate for the Vice President of Corporate Quality Systems, as needed

• Support development of metrics and measures for Inspection Data to drive assessment and continuous improvement

• Participate in budget forecasting, planning, and tracking; monitor and maintain activities to stay within budget

• Provide coaching and mentoring of team members with training / orientation / qualification of new Quality staff

• Promote continuous improvement

• Provide support with the GxP Inspection Management Team for other inspection types (e.g. GLP/GLP and PV inspections)

• Other duties as assigned

Working Conditions & 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 the essential functions. While performing the duties of this job, the employee is regularly required to:

• Experience prolonged sitting with some walking, bending, stooping and stretching.

• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.

• Have a normal range of vision.

Supervisory Responsibilities:

The following Manager/supervisor level roles will directly report to the Senior Director Global Quality Systems: Director QA, Associate Director QA, Senior Manager QA, Manager QA, Consultant of Quality Assurance, Intern Quality Assurance.

Minimum Qualifications:

• Bachelor’s degree in a technical field (e.g. microbiology, chemistry, engineering, etc.) required

• 15+ years of leadership in Quality Management Systems and excellent understanding of business processes and how they are translated to digital solutions.

• Solid experience hosting inspections and audits and to comfortably be responsible for presenting

• A minimum of 10 years working in a Management role

• Experience working in the Biopharmaceutical industry

• Experienced in human performance processes

• Strong technical internal audit skills, including IT audit

• Familiar with operating conditions across diverse markets, including mature and emerging markets is desirable.

• Solid knowledge of governance, risk management and compliance program frameworks.

• Proven experience in developing and implementing risk-based audit plans.

• High level of integrity, ethics, and professionalism.

• Ability to work collaboratively with cross-functional teams and senior management.

• Strong leadership and team management skills.

• Demonstrated knowledge of global GxP practices required – Good Clinical Practices, Good Manufacturing Practices, Good Laboratory Practices, European Medicines Agency requirements, as well as regulatory requirements regarding computerized systems (21 CFR Part 11 and EU Annex 11)

• Knowledge of GXP regulations and guidelines, as it pertains to Quality Systems

• Ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple

• Ability to work effectively with various technical groups and a strong working knowledge in the following disciplines: API or DP manufacturing, analytical development/QC

• Ability to work in a collaborative team environment is essential, with a customer-focused approach

• Strong decision maker with the ability to utilize critical thinking to problem-solve

• Must have strong interpersonal and communication skills

• Experience writing, reviewing and editing SOPs, as well as other document types

• Strong analytical and organizational skills. To understand and accept his/her recommendations.

• Candidate needs to possess excellent people skills to influence, motivate, teach, and encourage direct staff as well as peers and senior leaders

Preferred Qualifications:

• Certified Auditor

• Advanced degree in a scientific discipline preferred.

• Experience in interaction with customers and enjoying the privilege of establishing and maintaining trusting relationships.

• Previous Organizational Change Management experience

As part of any recruitment process, FUJIFILM Diosynth Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

This is a global position that will support all our FDB sites. This position can be based at any of our locations around the globe. Benefits and compensation will be governed by the location that you are based from and considered your home site.

Although this may be a remote posting, the incumbent must reside within a reasonable commuting distance from one of the FDB US locations. The US salary range for this position is $220,000 to $290,000. Pay within this range varies by work location and is dependent on job-related knowledge, skills, and experience.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, genderidentifyor any other protected class. Ifan accommodationtothe application process is needed, please e-mail FDBUHR@fujifilm.com .

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumessubmittedby search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will bedeemedthe 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 wassubmittedoutside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

Job Locations US

Posted Date 13 hours ago (10/29/2024 1:27 PM)

Requisition ID 2024-28065

Category Quality Assurance

Company (Portal Searching) FUJIFILM Diosynth Biotechnologies