Director of Corporate Quality Assurance and Compliance
3 months ago
Overview
The Director of Corporate Quality Assurance and Compliance 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 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.
External US
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow’s medicines – our Genki – will always be our driving force. Whilst working asthe Director of Corporate Quality Assurance and Compliance in our global Quality team, you’ll be joining other motivated individuals who fuel one another’s passions and embrace every day as an opportunity. We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the trusted CDMO of choice for our customers.
In partnership with the site leaders, the Director of Corporate Quality Assurance and Compliance sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations. The incumbent will be responsible for leading various 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 digitally enabled corporate quality and compliance program that can respond quickly to a multifaceted geopolitical environment. The individual will be sought out as the subject matter authority and will lead project teams of quality systems professionals to ensure quality and compliance across the FDB network. The ideal candidate has the ability to work with ambiguity, creative approach to problem solving and ability to define a clear path forward with emphasis on keeping things simple. They will work in a collaborative team environment with a customer-focused approach. They are a strong decision maker with the ability to utilize critical thinking to problem-solve and must have strong interpersonal and communication skills.
This role will report directly to the VP of Corporate Quality & Compliance at FDB and will have no direct reports.
Main Activities and Responsibilities:
Lead the Global roll-out of the Veeva system to be the one KojoX quality management system of FDB Identify and lead the implementation of other digital quality systems to be the one KojoX quality management systems of FDB Contributes to defining quality objectives and strategies to meet customer requirements and FDB goals and objectives. Effectively manage the development, implementation, approval, and maintenance of global quality assurance systems and processes. Facilities groups or teams through the problem-solving and creative thinking processes leading to the development and implementation of novel approaches, systems, structures, and methods to ensure overall quality processes and services across the organization. Generates creative fresh solutions and approaches to customer issues and organizational quality processes. Partners in cross-functional activities to achieve organizational objectives. Design, develop and deploy digital quality systems in accordance with regulatory authority guidance and expectations Share strategic responsibility for management of quality systems, including but not limited to Quality Event management, Quality governance boards, Quality risk management program, continuous improvement projects Ensure that quality systems are designed and operate as appropriate to provide support in development and commercialization for GXP areas Define strategy and execute continuous improvement opportunities within Quality Systems Assess Quality Management System processes for potential gaps and remediation to ensure compliance with regulatory guidelines Own and drive completion of Corporate Quality Systems deviations, CAPAs, and change controls Establish metrics and report out to management and cross-functional areas to ensure routine monitoring of quality system health Oversee and manage the electronic quality management system, including workflow configuration and upgrades, as needed Be the SME and represent Quality on cross-functional teams Participate in audits and inspections representing Quality Systems Support departmental budget planning Other duties, as assigned by management Leads and manages processes that provide oversight and guidance to monitor and assure compliance with quality management system requirements and all applicable good practice regulations, e.g. clinical (GCP), commercial (GMP), Laboratory (GLP), Risk evaluation mitigation strategy, etc. Systems Thinking – Implements quality related solutions to organizational problems and develops organizational or service delivery systems in a way that factors in or encompasses the interactions of all the systems and organizational entities involved. Ensures FDB global procedures, SOPs, guidelines, and other standard materials required for departmental function are prepared, reviewed, and that staff are trained. Contribute to monitoring departmental actions and costs related to the overall utilization of resources required to meet operational requirements. Participants in due diligence and integration activities of newly acquired organizations. With the support of the FDB Legal Department interprets global legislation, regulations, and guidance for FDB to develop policies and standards, identify gaps and redundancies, and coordinate and implement remediation in collaboration with FDB senior management and other groups such as legal.Background and Education Requirements:
Bachelor’s degree in a technical field (e.g. microbiology, chemistry, engineering, etc.) required 10 years of (bio)pharmaceutical industry experience with at least 5 years of Quality and process leadership experience. 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 Previous experience identifying and deploying digital quality systems solutions across national and international networks Ability to work effectively with various technical groups and a strong working knowledge in the following disciplines: API or DP manufacturing, analytical development/QC 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 leadersPreferred Qualifications:
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 experienceWorking 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.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, gender identify or any other protected class. If an accommodation to the application process is needed,
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Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full timeJob Title: Director of Corporate Quality Assurance and ComplianceAbout the Role:The Director of Corporate Quality Assurance and Compliance will play a critical role in shaping the global quality strategy and policy for Fujifilm Diosynth Biotechnologies (FDB). This individual will be responsible for ensuring excellence in compliance and the ability to...
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Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full timeJob Title: Director of Corporate Quality Assurance and ComplianceAbout the Role:The Director of Corporate Quality Assurance and Compliance will play a critical role in shaping the global quality strategy and policy for Fujifilm Diosynth Biotechnologies (FDB). This individual will be responsible for ensuring excellence in compliance and the ability to...
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Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full timeJob Title: Director of Corporate Quality Assurance and ComplianceThe Director of Corporate Quality Assurance and Compliance will play a critical role in shaping the global quality strategy and policy for Fujifilm Diosynth Biotechnologies (FDB). This position requires a seasoned professional with expertise in quality management systems, regulatory compliance,...
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Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full timeJob Title: Director of Corporate Quality Assurance and ComplianceAbout the Role:The Director of Corporate Quality Assurance and Compliance will play a critical role in shaping the global quality strategy and policy for Fujifilm Diosynth Biotechnologies (FDB). This individual will be responsible for ensuring excellence in compliance and the ability to...
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Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full timeJob SummaryThe Director of Corporate Quality Assurance and Compliance will be responsible for developing and implementing 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.Main ResponsibilitiesLead the...
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Stockton-on-Tees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full timeJob SummaryThe Director of Corporate Quality Assurance and Compliance 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...
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