Director of Corporate Quality Assurance and Compliance

3 weeks ago

StocktononTees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time

Job Summary

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.

Main 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.
  • Facilitate 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.
  • Generate creative fresh solutions and approaches to customer issues and organizational quality processes.
  • Partner 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.

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 leaders

Preferred 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 experience

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.

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, please contact the Human Resources department at [insert contact information].

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