Associate Director, Cell Therapy Learning Lead

The

Associate

Director,

Cell Therapy

Learning Lead

(

AD

CT

LL

)

role

will work in a collaborative manner with other members of the

Cell Therapy Clinical Operations

(CTCO)

Business Processes, Quality & Learning

(BPQL)

team

.

This role

is responsible to

both

oversee and lead the

develop

ment

of

learning materials

for Cell Therapy

specific

procedures as well as to

support the

delivery Clinical Execution Excellence, ensuring an effective end-to-end delivery of clinical trials.

The

AD CT LL

role will function

to support

teams across CTCO

in order to

ensure that all CTCO trials are

prepared for

both

internal and external audits

and inspections

.

The

AD CT LL

role has a specific area of expertise within CTCO BPQL in the following manner:

Work closely

with CTCO Process Owners

in order to

ensure that any established processes adhere

to AZ global quality standards

.

Deliver or drive the development

of

quality

related

initiatives and

continuous

improvement programmes

that would support improved Quality and

C

ompliance

within

CTCO trials

and within CTCO-related processes and initiatives

.

F

irst

line

of

Q

uality support to

all

CTCO trials

and CTCO-related initiatives.

To

operate

within established AstraZeneca

networks

, including but not limited to Process Quality,

Learning & Transformation

(PQLT).

Typical responsibilities:

Learning Materials Development

Lead and manage the delivery

of assigned learning

objectives

and

priorities for CTCO

Ensuring that

existing and updated materials meet AZs requirements

regarding

process clarity,

CT

CT

LL

work

s

closely

wit

h the BPQL team

,

ensuring:

Insights related to CTCO-specific

p

rocess-related

issues requiring corrective actions are documented for potential future process improvements.

Process KPIs & measurement:

Support de

velop

ment

,

using quality-related data

to

inform process and business improvement activities

.

Perform

effective

ness checks as needed

to

support the remediation of study-related CAPAs and if needed to

verify the

uptake and adoption of new and changed

CTCO-related

processes

.

Escalate

, as needed,

to

2

nd

Line Quality and the broader CTQN

any issues or risks

related t

o any

CTCO-related studies or initiatives

Communicate on a routine basis, relevant quality-related

insights

and feedback to the greater CTCO organization