VP of Quality Systems and Compliance

Company: FUJIFILM Holdings America Corporation
Location: Durham
Posted on: May 14, 2022

Job Description:

Overview We are seeking a highly motivated individual to join us as Sr. Director, Global Quality Systems and Compliance. The job holder will provide oversight and guidance to our Global Quality processes, systems and compliance activities for the Fujifilm Diosynth Biotechnologies' growing organization. The successful candidate will lead a small global team of skilled professionals each specialising in quality critical areas which significantly impact our colleagues daily activities and our customers experience. External US The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important and we are looking for talented candidates to join us. We're growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people's lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you'll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. At FDB, passion - what we call Genki - lives inside everything we do. It's within each of our employees, inside our technology, behind our science, fore to our manufacturing process and facilities, in our therapies and biologics, and central to the accomplishments we help make possible for our customers. It's the Genki inside FDB that unites us across sites, energizes our work together forward, and peoples us toward our shared purpose of advancing tomorrow's medicines, together.We are seeking a highly motivated individual to join us as Sr. Director, Global Quality Systems and Compliance. The job holder will provide oversight and guidance to our Global Quality processes, systems and compliance activities for the Fujifilm Diosynth Biotechnologies' growing organization. The successful candidate will lead a small global team of skilled professionals each specialising in quality critical areas which significantly impact our colleagues daily activities and our customers experience.The job holder should possess the ability to apply a strategic view to the business while having proven skills of implementing major initiatives.Key responsibilities

• Lead a team of skilled colleagues who each have responsibility for a specific Global Quality Critical area. Ensuring a positive team dynamic which focuses on listening, encouraging and engaging both each other but equally employing those same values with our site based and business focused colleagues who we are here to support.
• Engage in building a positive Quality Culture and be a key advocate for One Team FDB that challenges the norm, embraces novel thinking and is at pace with technological advancements in line with compliance expectations and leading industry quality standards.
• Provide guidance and support to the sites and business units on wide reaching quality issues that lend themselves naturally to a more standardised model (operating standard).
• Receive input and learn what the needs of the ever growing organisation is and ensure that this is reflected in the Global Quality Strategy associated global quality systems.
• Work with leadership teams, internal functional management, and external regulatory bodies to ensure we sustain the current and anticipated levels of quality standards.
• Determine need, develop and maintain applicable company global policies and operating standards in compliance with applicable regulations and company strategies and philosophies.
• Prepare Global Quality budgets, monitor budgetary performance, and justify costs associated with activities within the Global Quality arena.
• Establish specific Global Quality goals, milestones and metrics with the objective of fulfilling our customer, regulatory agencies and internal customers expectations in terms of service, quality, efficiency and timelines.
• Provide critical quality topics for presentation to the Global Leadership Team for consideration and assessment.
• Participate in strategic planning and plan implementation, as well as business optimization, to help assure the success of the FDB organization.
• Support the greater Quality organization when engaging with regulatory agencies such as FDA, MHRA and EMA
• Participate in key client activities including, but not limited to relevant client meetings and Material Review boards as needed.
• Oversee the global quality assurance audit program at FDB, developing an appropriate audit schedule, conducting and reporting quality assurance audits and audit follow up activities.
• Oversee effective and compliant cGMP quality system computer and documentation systems.
• Manage activities related to a centralized quality document control function within FDB
• Support with identifying and interpreting regulations, directives, guidelines, and other pertinent information issued by applicable global regulatory agencies and other regulatory organizations as they pertain to the quality program and compliance activities.
• Perform other related duties as assigned.Essential skills
  • S./B.A. in a science, engineering, or related technical field is required
  • Advanced degree(s) preferred
  • 10+ years progressive experience working in the Pharmaceutical Industry, with varied functional and CDMO experiences desired
  • Experience working with business stakeholders within a cross-functional matrix environment
  • Fluency in relevant international regulations and guidelines (EMA, MHRA, FDA, ICH, etc.).
  • Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills. -Desirable skills
    • Has successfully worked in an international environment with a broad spectrum of cultures and backgrounds
    • Proven track record in scoping and managing large scale introduction of global systems and processes and monitoring the continued implementation and development of said systems and process
    • Ability to listen to both internal and external customer needs and expectations and adapt the Quality management system accordinglyFDBU: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 e-mail FDBUHR@fujifilm.com.FDBTWe are an equal opportunity and affirmative action employer. - All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state or local law. -If an accommodation to the application process is needed, please e-mail - -or call -979-431-3500.To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the 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 was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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