Senior Specialist Marketing Company Operations Quality Poland

AstraZeneca is one of the world’s leading biopharmaceutical companies, delivering innovative medicines for diseases that pose major challenges to modern healthcare. Our strength comes from the diversity of our people—their experiences, passion, and potential—fueling meaningful progress every day. We act with shared values and the highest ethical standards, combining science, responsibility, and ambition.

If you want to make a real impact for patients and grow in an environment that values diversity and collaboration, join us as

Senior Specialist Marketing Company Operations Quality Poland

r

esponsible party for overseeing the design,

implementation

and delivery of a common Quality system

and strategy for GMP and GDP activities across in Commercial marketing company for

all of

the AZ product

portfolio in country. Participates in development of Global AZ MCOQ Quality Strategy and executes country

strategy for MCOQ Quality and Marketing Company GMP/GDP aligned with AZ’s bold ambition strategy for

market expansion, product

launches

and accessibility. Accountable for assurance of compliance with worldwide

standards for all local GMP & GDP activities and connects the MC offices the broader Operations Quality and

R&D organisation

operating

under One AZ QMS.

Core Accountabilities

For given country, develop, support and drive excellence in MCOQ GMP&GDP Quality activities to

maintain

the

local License to Operate.

Primary point of GMP&GDP contact for the country and

maintains

an effective governance structure to ensure

oversight of quality activities.

Provides leadership for GMP & GDP (Good Manufacturing and Good Distribution Practice) strategy and

activities across market and commercial SET area as the Quality partner to Commercial SET leader, Regional

Commercial Head and Global Safety

.

Participates in defining the strategy for the commercial global

markets

ownership and execution of MCOQ

GMP and GDP Quality System and framework in country

.

Define, develop,

deploy

and

monitor

the GMP/GDP policies and standards and execution in country markets

.

Accountable for a Country MC Quality Management Review process,

preparation

and execution and

escalations to Operations, Commercial and R&D Sr. Leadership and SET members

.

Represents

Quality on cross-functional and cross SET teams and steering committees related to MC market

.

Drive global standardisation,

simplification

and improvement of MCOQ Quality business processes.

Develops and sustains a high-quality organisation that delivers against global processes, and aims to

continuously improve in competence, compliance

standards

and innovative delivery of results.

Provide training, supporting and coaching structure for regional Quality MCOQ network roles

.

Participates in strategy and regional

objectives

setting for the MCOQ organisation

.

Is the primary point of

expertise

for GMP & GDP activities

impacting

the MCOQ organisation in country

.

Plans, reviews and manages budget for the Country MCOQ Quality organisation

.

Accountable for compliance assurance and working to one set of GMP & GDP standards and processes, as

well as common

GxP

process across the MC

GxPs

.

Accountable for Country specific regulatory requirements related to manufacture and distribution of AZ

product in country, including but not limited to release of product atched, resolution of Issue

Management

,

recalls,

influence and decisions on local regulatory agency interactions, audits and inspection

readiness and compliance to gain nd

maintain

AZ licence to

operate

.

Responsible for MCOQ GMP&GDP input into divestments/acquisitions/licensing agreements in country

.

Demonstrated ability to work independently and in project settings to deliver

objectives

.

Keeps own knowledge of best practices, industry

standards

and new developments in quality management

up to date

.

Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate

future developments in AstraZeneca’s Quality related needs

.

Responsible for managing Quality Standards and expectations across a broad range of services

in order to

provide a high quality,

timely

and cost-effective service

.

Employs prepared information to discuss, plan and help carry out improvement plans, priority setting,

investigation reports,

quality

or performance improvement recommendations

.

Ensures adherence to Quality, Health and Safety, Good Manufacturing Practice, Good Laboratory Practice

and regulatory requirements of own work and others work

.

Responsible for ensuring that policies and standards meet regulatory requirements

.

Ensures compliance with Good Manufacturing Practice, Safety

Health

and Environment and all other

relevant regulations

.

Carries out compliance reviews and reporting for external suppliers including issue resolution with senior

M

anagement

and AZ site leaders, this may include, but is not limited to, the review and approval of investigation reports

and

participation in issue management teams

.

Responsible for country preparation for Regulatory Agency and AstraZeneca inspections/audits and

r

esponses

.

Supports local MC to deliver the license to

operate

, including but not limited to support for GMP&GDP

audits and inspections, implementation effective

self-assessment

programs in the country of responsibility.

Responsible for ensuring QMS compliance and continuous improvement in the Region and all issues are

M

anaged

concerned and closed on time, risks are

identified

and escalated to Global Quality.

Promotes a Quality Culture in the MC sets strategy in the region and locally for execution of GMP/GDP

excellence.

Responsible for the achievement of country KPIs and objectives/Quality Plans. Ensure country trends are

addressed through development of country continuous improvement plans.

Adheres to Good Manufacturing Practice and Safety Health and Environment and ensures regulatory

compliance

Contributes to development procedures in area of specialism and provides some technical input into the

development of global standards for function and globally

.

Proactively looks for opportunities to

identify

change and make efficiency savings, influence decisions and

deliver the results whilst ensuring and

appropriate level

of compliance

.

The jobholders are directly involved with/lead working groups, teams, and projects to proactively provide

a

global perspective and to drive consistency and standardization in all matters related to quality and GMP

compliance

.

3rd Party management responsible for storage & distribution of samples to HCP

.

Education, Qualifications,