Director of Corporate Quality Assurance and Compliance

4 weeks ago

StocktononTees, Stockton-on-Tees, United Kingdom Fujifilm Corporation Full time
Job Title: Director of Corporate Quality Assurance and Compliance

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 withstand internal and external scrutiny.

Key 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
  • Contribute 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 problem-solving and creative thinking processes to develop and implement novel approaches, systems, structures, and methods to ensure overall quality processes and services across the organization
  • Generate creative 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
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
  • 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.

  • 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

Fujifilm Diosynth Biotechnologies (FDB) 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 identity, or any other protected class.

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