Sr. Dir, Global Quality Systems Governance
Company: Emergent BioSolutions
Posted on: August 6, 2022
Those who join Emergent BioSolutions feel a sense of ownership
about their future. You will excel in an environment characterized
by respect, innovation and growth opportunities. Here, you will
join passionate professionals who advance their scientific,
technical and professional skills to develop products designed-to
The Director/Sr. Director of Global Quality Systems Governance will
oversee the deployment of Emergent BioSolutions Inc. (EBSI) Quality
Management System (QMS) framework across the GxP lifecycle. The
position will oversee the strategy, execution and performance of
EBSI's QMS including; defining, implementing and overseeing
execution of the framework, provide leadership and guidance to
Business Process Owners (BPOs) in design/development of their
respective quality system(s). Ultimately, the position will be
responsible to achieve an effective, efficient and continuously
Reasonable accommodations will be made to enable individuals with
disabilities to perform the essential functions.
--- Lead annual global QMS Quality planning activities, to drive
quality performance and quality across GxPs.
--- Leads the development and execution of EBSI's enterprise wide
QMS Governance Controls and related strategic, transformational and
continuous improvement objectives.
--- Ensure QMS framework processes are established, implemented,
audited, and continuously improved.
--- Establish and lead QMS Governance Board ensuring a platform for
the voice of impacted stakeholders, prioritization of deliverables
against business strategy, and transparency of the health of
systems across the enterprise and within the impacted
--- In collaboration with Quality System Business Process Owners,
develop project/change management and communication plans and
documents to ensure stakeholder engagement and progress as quality
systems are changing/continuously improving.
--- Ensure clear, concise, regulatory compliant policies,
procedures, are defined and implemented through the correct
implementation of EBSI's Enterprise One QMS framework.
--- Serve as a change agent for enterprise mindset (EBSI's One QMS
harmonization) efforts across sites, functions, and business units
promoting positive behavioral change.
--- Define metrics to measure and report on process
adoption/compliance (e.g., gap assessment tracking).
--- Ensure timely and accurate reporting via Quality Review
Boards/Management Review on the performance of EBSI's One QMS along
with associated needed improvements.
--- Participate in quality system process optimization
core/extended team meetings as required.
--- Collaborate with training teams to provide insight and guidance
on the planning and implementation of quality system related
--- Lead cross functional teams consisting of representatives to
ensure continuous improvement of the governing QMS framework
processes and related technologies.
The above statements are intended to describe the nature of work
performed by those in this job and are not an exhaustive list of
all duties. Nothing in this job description restricts managements
right to assign or reassign duties and responsibilities to this job
at any time which reflects management's assignment of essential
MINIMUM EDUCATION, EXPERIENCE, SKILLS
--- Degree level in Life Sciences and/or Information Systems,
Advanced degree and/or MBA an advantage
--- People management experience (direct/matrix).
--- 10-12 years of experience in the Biopharma/Pharmaceutical
industry with cross-functional experience in quality systems
--- Excellent leadership, interpersonal, communication, negotiation
and problem-solving skills
--- Sound understanding of regulated activities, health authority
expectations, and GxP.
--- Excellent organizational awareness (e.g., Research &
Development, Commercial Manufacturing, interrelationship of
departments, business priorities), including significant experience
working cross-functionally and in global, cross- cultural
--- Experience developing and executing large-scale organizational
change, including change management strategy and planning.
--- Proven ability to understand complex processes/problems and
facilitate coach teams to optimal solutions
--- Ability to design and implement global business
processes/policies with a critical thinking approach and enterprise
--- Proven experience managing/influencing stakeholders across a
broad spectrum of GxP topics.
Successful applicants for this position must be fully vaccinated
against COVID-19 as a condition of employment. Individuals with
qualifying medical issues or sincerely held religious beliefs or
practices that may prevent them from getting the vaccine may
request an exemption from the vaccine requirement.
There are physical/mental demands and work environment
characteristics that must be met by an individual to successfully
perform the essential functions of the job. This information is
available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with
disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action
Employer and values the diversity of our workforce. Emergent does
not discriminate on the basis of race, color, creed, religion, sex
or gender (including pregnancy, childbirth, and related medical
conditions), gender identity or gender expression (including
transgender status), sexual orientation, age, national origin,
ancestry, citizenship status, marital status, physical or mental
disability, military service or veteran status, genetic information
or any other characteristics protected by applicable federal, state
or local law.
Information submitted will be used by Emergent BioSolutions for
activities related to your prospective employment. Emergent
BioSolutions respects your privacy and any use of the information
submitted will be subject to the terms of our .
Emergent BioSolutions does not accept non-solicited resumes or
candidate submittals from search/recruiting agencies not already on
Emergent BioSolutions' approved agency list. Unsolicited resumes or
candidate information submitted to Emergent BioSolutions by
search/recruiting agencies not already on Emergent BioSolutions'
approved agency list shall become the property of Emergent
BioSolutions and if the candidate is subsequently hired by Emergent
BioSolutions, Emergent BioSolutions shall not owe any fee to the
Keywords: Emergent BioSolutions, Albany , Sr. Dir, Global Quality Systems Governance, Other , Maryland, New York
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