IT Quality Management Regional Lead - New York, United States - AstraZeneca

Description

Job Title -
ITQuality Management Regional Lead
Career Level - F
AstraZeneca is a global, innovation-driven

BioPharmaceutical

business that focuses on the discovery,

development

and commercialisation of prescription medicines for some of the world's most serious diseases. But

we're

more than one of the world's leading pharmaceutical companies. At AstraZeneca,

we're

dedicated to being a Great Place to Work, where you are empowered to push the boundaries of science and unleash your ambitious spirit.

There's

no better place to make a difference to patients,

society

and the planet.
As

an


ITQuality Mana

gement

Associate Director

,

you'll

work in the
ITQuality & Compliance

team

of the Strategy, Performance & Quality Function in Global IT. This role is crucial to accelerating our compliance efforts as we integrate

new technologies

, like AI, that require a fundamental rethinking of compliance capabilities, frameworks, and delivery mechanisms to ensure all
ITprojects and services achieve compliance

.

You

will also

optimise

utilisation, managing engagement of resources in the most effective way and driving knowledge sharing and innovation.
Typical Accountabilities
As

an


ITQuality Management

Associate

Director, you will lead a

regional

team of

Quality Management professionals

to ensure

that our
ITsystems and services are compliant, reliable, and ready for inspection

s

. You will work across

the full lifecycle and value chain, delivering compliant

projects and services

r

eporting to

a

Director of
ITQuality Management

. You will

be responsible for

leading, managing and developing a high performing team of Global
ITQuality Management professionals, as well as

supporting

the broader
IT
QMleadership team to develop the skills and capabilities

for the future

across the full


QM
organisation.
In collaboration with the
QMLT,

you will

drive excellence and simplification in the design of our internal processes for supporting inspection readiness, ensuring adherence to standards and data principles

.
Using initiative and a self-driven approach to

identify

and deliver continuous improvement opportunities, the lead will be expected to:

E

nsure that

all


IT
systems used by sites

remain

compliant throughout

their

lifecycle

,

with

the

relevant

compliance policies

,

standards

and government

regulations.

Drive and deliver improvements in our Compliance performance through Lean and automation

to continuously improve Quality Management

services.

Utilise

effective education and training

to

help protect our

LtO

and embed a compliance

culture.

Own and embed the quality management planning approach and processes ensuring that organisational and supplier compliance risks are

identified

, assessed, and mitigated in support of AZ's license to

operate

.

Identify

, communicate, and manage trends in

operational

compliance risks, breaches, and issues, ensuring


CAPA
to mitigate the risks are discussed and agreed with

Stakeholders

Drive

accountability across
ITthrough effective planning, governance and

Operational Health

reporting of key

c

ompliance metrics and measures

by interpreting Quality insights for senior stakeholders

Provide compliance input to the preparation for

internal management reviews,

external regulatory and internal AZ inspections as

required

.

Drive

the continuous monitoring, improvement and digitisation

of our processes,

services

and tools,

through applying LEAN thinking and techniques, and exploiting tools

and

automation.

Apply specialist knowledge to support strategic thinking around how to manage compliance activities in the
IT
organisation.

Utilise your depth of industry and compliance experience to provide direction to programme/project

/service

managers and

system owners

, in the development of a risk-based approach for the delivery of

compliant


IT
solutions.

Collaborate closely with

the
QMLT to ensure

the provision of

appropriate


QM
resource

capability and

capacity

in line

with customer expectations,
ITstrategy and the needs of

AZ.

Ensure

capability within the team to

deliver high quality


IT

QM
project and system deliverables to support external regulatory

inspections.

Work with the wider Quality Management team to ensure changes to processes and accountabilities align to, and are compatible with, the AZ
ITPolicies and Standards

Essential skills and Experience
Knowledge of industry good practice and standards such as ISO 9000, ISO 27002, CMMI, GAMP,

GxP

, ITIL, S404 Sarbanes Oxley
Extensive experience in multiple areas of quality and compliance within a Pharmaceutical/Biotech environment
Leading diverse groups of quality,

compliance,

and business stakeholders with varied and often conflicting priorities
Developing quality, compliance and risk strategies and articulating the strategic direction for regulated organisations
Experience of

running Quality and Compliance

across functions and geographies in large,

complex

and sometimes uncertain
ITenvironments, leading

business

and
ITpartners from across the business
Continuous improvement/Compliance Improvement
Driving risk,

quality

and compliance assurance across multiple aspects of global operation
Internal auditing and external regulatory inspection management
Proven challenge, negotiation & influencing

capabilities.
Strong Change Management Leadership
Strong collaboration and relationship building skill with both internal and external stakeholders, enabling effective enterprise

collaboration.
Strong people development

and motivation

skills, attracting talent and investing in long-term development of

others.
Highly constructive and enabling

coach.
Good

Presentation, Communication & Facilitation skills
Strong leader

drives accountability and inspires the organization to do the right

thing.
Pragmatic decision making - analyses

highly complex

situations, assessing risks and balancing strategic and tactical compliance/quality

requirements.
Tenacity - challenges the status quo by surfacing challenging and complex issues to get simple and desirable

outcomes.
Ability to stay calm under

pressure.
Excellent consulting and business engagement experience, capable of discussing technical
ITterms with a non-technical business

audience.
A self-starter with

high levels

of drive, energy,

resilience,

and a desire for professional excellence

Desirable Skills/Experience:

Design and implementation of Quality

Management

Systems as integral to an overall Business System
Broad
ITmanagement experience including project or service

management.
Familiarity with technical concepts in infrastructure or applications
Relevant External Professional Qualification/Certification/Experience
Ability to drive innovation in a Compliance and Quality

environment.
External Advocacy

representing

global organisations and collaborating with quality/compliance/risk related external industry forums/trade

associations.
Key Relationships to reach solutions.
Internal (to AZ or team)
Internal audit & assurance teams/functions.

ITand Business groups supporting the full lifecycle and value chain

:

Project

/Service

Management

Enterprise/Information

Architecture


ITSecurity

Other SMEs/Standard Owners

System Owners

Business

Performance

Service Introduction and Service Delivery

Procurement

Business QA

External (to AZ)
Third Party Suppliers / External Consultants

Regulatory inspectors/auditors

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