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.
Keywords: FUJIFILM Holdings America Corporation, Durham , VP of Quality Systems and Compliance, Executive , Durham, North Carolina
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