Associate Director, Quality Risk Analysis
Company: Alexion Pharma Spain S.L.
Posted on: February 25, 2021
Associate Director, Quality Risk Analysis Attention: If you are
a current Alexion employee, please apply via
Alexion's internal Life & Career portal . Note that you will need
to be connected to the VPN if you are applying away from the
office. Alexion does not contact candidates via instant messaging
or chat tools. At no time will we ask candidates for fees
associated with obtaining software, nor do we provide employees
with a cashier's check to purchase new equipment. If you are
contacted in this manner, please be aware that it is fraudulent,
and please do not provide any information or money to these
individuals. Applicants should only apply through this Alexion
website. Any fraudulent activity should be reported to
GSOC@alexion.com Share this job * This position can be based from
the Alexion location of Boston, MA or can be remote/virtual, based
anywhere in the United States and may require up to 20% travel.
Position Summary The Associate Director Quality Risk Analysis will
be instrumental in contributing to the growth, integration, and
further advancement of Quality Risk Management and Risk Analysis
across Alexion's Global Quality and Operations organizations.
She/He will be responsible for the oversight and maintenance of the
Quality Risk Register and Risk Reporting platform and serve as the
key point of contact for the organization for this core service.
She/He will actively be involved in risk workshops and risk
assessments, as well as the launch of a new Center of Excellence in
Risk Management. This is a new and exciting role for the
organization and will shape the strategy for risk reporting and
risk management plan, which will include establishing key risk
indicators, thresholds and organizational risk appetite framework.
Procedures & Processes
- Responsible for assiting in the evaluation of the effectiveness
and ongoing evolution of Alexion's Quality Risk Management Program
and Approaches through development of mitigation and improvement
- Work in close collaboration with the other business units to
ensure consistency in risk assessment, management, mitigation, risk
register documentation and actioning.
- Support the development, execution and/or facilitation of Risk
Assessments (GxP), Risk Workshops, and Risk Management
- Direct the implementation of compliant risk management
operations within area of responsibility by guiding teams on
accurate and timely responses to risk management issues and ensure
strategic approach to meeting company objectives.
- Drive a performance management culture by mobilizing and
developing individuals at all levels, encouraging cross-team
collaboration to achieve positive results for the
- Maintain Alexion's Global Quality Risk Register Platform,
including reporting and development of analytics, and key
attributes of enterprise risks.
- Monitor, analyze and prepare reporting of risks within the
Quality Operation's business units, including establishing risk
thresholds and key risk indicators.
- Conduct analysis of risk assessments and rankings and develop
risk analytics and reporting dashboards to support Management
Reviews and inform decision making.
- Contribute insights and key takeaways to Quarterly Management
Reviews, Executive Management Reviews and Board presentations.
- Support development of the data strategy for risk management,
as part of a larger data and analytics roadmap for Quality.
- Build a partnership model across the business to utilize data
and insights to look at innovative ways to assess and inform on
risk, outcome, and control (e.g. internal auditing, QMS Compliance)
- Challenge and stress test current risks and controls,
self-assessments and strategies.
- Coordinate with other organizational Risk and Compliance teams
as appropriate to ensure integrated end to end coverage of risks
and coordination of monitoring, assessment and other
- Contribute to the team's efficient and effective operation by
close collaboration with and monitoring risk management projects
and activities to control costs, mitigate risks, adhere to business
and industry standards and implement industry best practices.
- Broad knowledge and experience in risk management tools and
techniques (including, but not limited to: FMEA, FMECA, FTA,
- Strong knowledge of GXP compliance, as well as USP, PIC/S, ICH
and FDA guidelines is required
- Strong working knowledge of Operational Risk program elements
and principles including but not limited to Internal & External
Operational Losses, Risk Control Self Assessments (RCSA), Key Risk
Indicators, and Scenario Analysis
- Strong analytical and problem-solving skills
- Experienced in use of statistical software (e.g., SAS, Excel
VBA, Minitab and Tableau); solid and demonstrated understanding of
advanced statistical approaches
- Knowledge of Quality Systems
- Expertise in project management principles and application
including the ability to manage multiple projects simultaneously;
Ability to multi-task projects and evaluate priorities with minimal
Communication and Collaboration
- Must possess strong verbal and communication skills, and a
well-developed ability to constructively work across functional
areas and levels to achieve results.
- Ability to work in a Global Environment
- Proficiency in developing presentations to facilitate
meaningful discussions, with clearly communicated analysis,
findings, and impact
- Must demonstrate the ability to grow and perform in areas of
- Passion for excellence
- Bachelor's degree in business management, engineering or
science discipline is required
- Direct experience leading and supporting risk management
activities in a pharmaceutical, medical device, or related
regulated industry, is required (risk facilitation, training,
- 8+ years broad experience in Pharmaceutical Industry or a
related regulated industry. Valid operational experience includes
quality management, risk management or other relevant experience
working at a regulatory health authority. Broad business awareness
a plus. *LI-MB1 Some opportunities happen only once in a lifetime -
like a job where you have the extraordinary opportunity to change
lives. At Alexion, such opportunities arise through our unwavering
mission to serve patients and families affected by rare diseases.
These patients are our guiding star, and we act with integrity,
urgency, and discipline because we know their lives are at stake.
Alexion--is a global biopharmaceutical company focused on serving
patients and families affected by rare diseases and devastating
conditions through the discovery, development and commercialization
of life-changing medicines. As a leader in rare diseases for more
than 25 years,--Alexion--has developed and commercializes two
approved complement inhibitors to treat patients with paroxysmal
nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic
syndrome (aHUS), as well as the first and only approved complement
inhibitor to treat anti-acetylcholine receptor (AchR)
antibody-positive generalized myasthenia gravis (gMG) and
neuromyelitis optica spectrum disorder (NMOSD).--Alexion--also has
two highly innovative enzyme replacement therapies for patients
with life-threatening and ultra-rare metabolic disorders,
hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D)
as well as the first and only approved Factor Xa inhibitor reversal
agent. In addition, the company is developing several
mid-to-late-stage therapies, including a copper-binding agent for
Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for
rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D
inhibitor as well as several early-stage therapies, including one
for light chain (AL) amyloidosis, a second oral Factor D inhibitor
and a third complement inhibitor.--Alexion--focuses its research
efforts on novel molecules and targets in the complement cascade
and its development efforts on the core therapeutic areas of
hematology, nephrology, neurology, metabolic disorders and
cardiology. Headquartered in--Boston, Massachusetts,--Alexion--has
offices around the globe and serves patients in more than 50
countries. Further information about Alexion can be found at:
www.alexion.com . As a leading employer in our industry, Alexion is
proud to offer a highly competitive package of base and incentive
compensation as well as a comprehensive benefits program designed
to support the health, wellness and financial security of our
employees and their families. Benefits include group medical,
vision and dental coverage, group and supplemental life insurance,
401(k) with company match, tuition reimbursement, relocation
assistance and much more. Alexion participates in E-Verify process.
To learn more, please click on attached document(s)
Keywords: Alexion Pharma Spain S.L., Boston , Associate Director, Quality Risk Analysis, Executive , Boston, Massachusetts
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