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FUJIFILM Diosynth Biotechnologies
United Kingdom
17 days ago
FUJIFILM Diosynth Biotechnologies
Raleigh, North Carolina, United States
17 days ago
FUJIFILM Diosynth Biotechnologies
United Kingdom
17 days ago

Description

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.

 

The job holder will oversee and manage Fujifilm Diosynth Biotechnologies (FDB) Global Audit and Inspection program and ensure it is designed for global expansion. The scope includes; Internal Audit, Vendor Audit and Supplier Audit programs.

 

You will be responsible for monitoring compliance to company policies and procedures and partnering with teams to identify and resolve quality issues using risk analysis and root cause analysis tools. This role requires the candidate to be able to work independently, challenge the status quo, identify gaps and drive process improvements using appropriate Operational/Process Excellence and Risk Management tools. This role will provide support to the global network to ensure we are in an inspection-ready state of compliance, and will monitor state of control performance metrics to ensure the health and continuous improvement of the PQS within FDB.

 

In addition, this job role will significantly contribute to the assurance that material and service suppliers within the scope of FDB meet applicable Regulatory Authorities and FDB requirements.

 

This role reports to the Head of Global Quality Management and Compliance

 

Responsibilities (include but are not limited to):

  • Accountable for the development, implementation, and management of FDBs Global Audit and Inspection process
  • Supports the sites audit teams and provides oversight, and strategic guidance to drive global compliance audits and develop/improve audit and inspection processes and procedures
  • Perform and/or oversee the global internal quality system audit program
  • Perform and/or oversee vendor and supplier audits at planned intervals to evaluate effective control and maintenance of site quality systems.
  • Work effectively across the matrix by engaging with the broader process owner network and local sites or functional process owners in designing and deploying Global Audit processes.
  • Create mechanism for supporting Regulatory Inspections process and subsequent outcomes and help to resolve complex non-compliant issues by the most efficient and effective methods
  • Identifies, assesses, resolves, and where needed, escalates potential compliance and/or quality risks
  • Support deployment of these global processes in close cooperation with relevant functions and Site Leadership Teams (SLTs).
  • Define Community of Practices (COPs), including roles, operating mechanisms, communication strategies, and levels of training and access
  • Liaise with Quality Leadership Team and other functional leaders to identify and empower COP members
  • Provide leadership, coaching, and training for applicable COPs including both the technical processes and the behaviors necessary to optimize GA&I and grow a “Best in Class” Quality Mind-set
  • Support site and function teams during regulatory inspections or audits, which may include direct interface with inspectors/auditors and writing/reviewing responses which in particular have direct impact to Global Audit & Inspection Policies and processes
  • Collaborate with your other Global Quality colleagues and SMEs to drive optimal execution of processes across FDB and external partner
  • Maintain global expertise through ongoing training and participation in industry forums by participating/leading benchmarking initiatives to stay abreast of changes
  • Ensure oversight of proper maintenance and approval of Global change controls and Global cGMP documents that impact on the Audit and Inspection process
  • Review and approve proposed changes to Global A&I systems and procedures in conjunction with the Head of Global Quality Management and Compliance.
  • Provide Quality guidance to product development projects and technical transfer activities.
  • Executes Global quality objectives in alignment with business plan goals and process improvement initiatives
  • Identifies, designs, and delivers training programs to drive a quality culture which focuses on Patients, People and Customers
  • Provide support and coaching
  • Perform other duties as required.

 

 

Basic Qualifications:

  • A minimum of 10 years of experience in Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e., research, analytical, quality, engineering, manufacturing)
  • Knowledgeable of GxP regulations and expectations for core health agencies; thorough understanding of regulatory requirements in relation to PQS
  • Familiar with electronic quality system tools
  • Strong program and project management experience with proven track-record of managing cross-functional programs and ability to manage multiple, simultaneous projects
  • Familiarity with developing and executing organizational change, including change management strategy and planning
  • Ability to set priorities and deliver results both independently but also have the ability to identify, manage, and/or escalate issues and risks to timelines
  • Ability to influence, initiate, and manage change

Preferred Qualifications:

  • Strong knowledge of quality systems and global regulatory requirements (e.g. 21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
  • Minimum of 8+ years of management/leadership experience.
  • Experience in the medical and/or pharmaceutical industry.
  • Strong Knowledge of Shingo/Lean Principles and HOP Principles
  • Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
  • Identifying, writing evaluating and closing CAPAs and experience with internal and external audit principles.
  • Strong knowledge of quality risk management, aseptic processing, and change control strategies.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.

 

Desirable skills

Skills/Competencies:

  • Clear ability to listen to others and refocus thinking to ensure the best possible solution is reached within the framework of local regulations and the need for operational agility
  • Demonstrated flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities
  • Demonstrated influential leadership expertise and experience with all levels of the organisation
  • Clear ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
  • Ability to communicate with presence and influence preparing and presenting persuasive written and verbal materials with employees and management at all levels
  • Poses strategic thinking capability with strong project management focus and ability to execute on these decisions while balancing conflicting priorities to deliver value added business results that meet high quality requirements with tight deadline
  • Demonstrated change agility in anticipating and leading others through change and ambiguity

FDBU:

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.

 

FDBT

We 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 FDBTHR@fujifilm.com 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.



Requirements

Basic Qualifications:

  • A minimum of 10 years of experience in Biopharm/Pharmaceutical industry with cross-functional experience in one or more areas (i.e., research, analytical, quality, engineering, manufacturing)
  • Knowledgeable of GxP regulations and expectations for core health agencies; thorough understanding of regulatory requirements in relation to PQS
  • Familiar with electronic quality system tools
  • Strong program and project management experience with proven track-record of managing cross-functional programs and ability to manage multiple, simultaneous projects
  • Familiarity with developing and executing organizational change, including change management strategy and planning
  • Ability to set priorities and deliver results both independently but also have the ability to identify, manage, and/or escalate issues and risks to timelines
  • Ability to influence, initiate, and manage change

Preferred Qualifications:

  • Strong knowledge of quality systems and global regulatory requirements (e.g. 21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
  • Minimum of 8+ years of management/leadership experience.
  • Experience in the medical and/or pharmaceutical industry.
  • Strong Knowledge of Shingo/Lean Principles and HOP Principles
  • Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
  • Identifying, writing evaluating and closing CAPAs and experience with internal and external audit principles.
  • Strong knowledge of quality risk management, aseptic processing, and change control strategies.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.

 

Desirable skills

Skills/Competencies:

  • Clear ability to listen to others and refocus thinking to ensure the best possible solution is reached within the framework of local regulations and the need for operational agility
  • Demonstrated flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities
  • Demonstrated influential leadership expertise and experience with all levels of the organisation
  • Clear ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives
  • Ability to communicate with presence and influence preparing and presenting persuasive written and verbal materials with employees and management at all levels
  • Poses strategic thinking capability with strong project management focus and ability to execute on these decisions while balancing conflicting priorities to deliver value added business results that meet high quality requirements with tight deadline
  • Demonstrated change agility in anticipating and leading others through change and ambiguity

FDBU:

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.

 

FDBT

We 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 FDBTHR@fujifilm.com 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.

Job Information

  • Job ID: 63244613
  • Location:
    United Kingdom
    Denmark
    Raleigh, North Carolina, United States
    Holly Springs, North Carolina, United States
    College Station, Texas, United States
    Thousand Oaks, California, United States
  • Position Title: Director of Global Quality Audit and Inspection (GA&I)
  • Company Name For Job: FUJIFILM Diosynth Biotechnologies
  • Job Function: Quality Assurance
  • Job Type: Full-Time
  • Job Duration: Indefinite

Please refer to the company's website or job descriptions to learn more about them.

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