Job Description

Pfizer is the world\xe2\x80\x99s premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for people. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Why Patients Need You

Our Temperature Control Technology and Innovation (TCTI) validation team makes sure that customers and patients have the medicines they need, when they need them with 100% compliance. You\xe2\x80\x99ll help bring medicines to the world even faster by embracing challenges, imagining what\xe2\x80\x99s possible and taking action to make it a reality.

What You Will Achieve

Working within a dynamic validation team of TCTI and Supply Chain Experts, you will play a critical role in Supporting the thermal qualification of controlled temperature shipping systems for Intercompany Operations and In-Market distribution to support the efficient flow of products and services through the Pfizer supply chain cycle. You will ensure that the products arrive on time and within acceptable quality parameters, by establishing strategies for selecting thermal packaging conveyances for the Global Supply chain.

Through your extensive knowledge in Cold chain & temperature-controlled management, you will guide the execution and continuous improvement of logistics processes and systems to meet customer requirements.

As a manager, you will be accountable for promoting, deploying, and supporting the implementation of a One-Pfizer approach for temperature control technology and innovation across the network. You will be able to take a leadership role to facilitate agreements between different teams. It is your dedication and hard work that will make it possible for Pfizer\xe2\x80\x99s customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

The Transport Qualification Manager will be responsible for the following:

Support the thermal qualification of controlled temperature shipping systems for Intercompany Operations and In-Market distribution.

Supporting timely filing of MLA/BLA, and other MOH/BOH licensing and regulatory amendment applications

Establishing strategies for selecting thermal packaging conveyances for the Global Supply chain

Establish requirements for global thermal profiles per global MOH and BOH requirements in support of qualification and thermal bracketing strategies.

Ensure the execution of shake/drop and shock/vibe studies are executed per ASTM standards.

Coordinate training and implementation of controlled temperature shipping system for Pfizer Manufacturing and Distribution Centers

Support thermal studies across the network to support Zero Defects Strategy

Responsible for compiling data to be filed in the Qualification and Validation section of Shipping Solutions in regulatory dossiers.

ROLE RESPONSIBILITIES

New Product Launch (NPL) Support:

Oversee the deployment of controlled temperature shipping technologies including the identification, selection, qualification and implementation of solutions to support Business and Operational unit requirements.

Work with PharmSci and Global Technical Services teams to provide controlled temperature shipping technology perspectives and support for new products.

Serve as the technical representative to support GTS for controlled temperature logistics.

Act as a key interface/SME for controlled temperature shipment technologies between Business and Operational units for all NPL\xe2\x80\x99s

Responsible for executing data models using global seasonality data for the development of temperature control solutions.

Leverage controlled temperature shipping component supplier capabilities in the initiation and evaluation of system development/improvements.

Establish strategy for the execution of IQ/OQ/PQ for new product launches .

Lead for query and audit responses regarding commercial transport.

Existing Product Support:

Review deployed controlled temperature shipping technologies including qualification of implemented solutions and execute studies as necessary to close identified gaps.

Contribute to the regional controlled temperature packaging visibility initiative.

Serve as the key SME/technical representative to support for controlled temperature logistics for BAU.

Leverage controlled temperature shipping component supplier capabilities in the initiation and evaluation of system development/improvements.

Support annual-regulatory amendments for shipping validation

Validation and qualification support

When required, will author operational, performance qualification protocols and reports.

Responsible for drafting technical documentation supporting qualification strategies established by Global TCTI Functional leads.

Ensures logistics compliance with regional regulatory requirements where accountable.

Distribution Warehouse Operational Support:

Responsible for providing technical-transfer training of the controlled temperature shipping solution.

Ensure work instructions from packing/unpacking and appropriate change-control support is provided.

Support during Supply Chain Quality Investigations

Writing test plans and protocols for operational support as needed

General Operations Support

Real time shipment intervention and ensuring follow up actions with transportation suppliers are actioned against predefined playbooks and Standard Operating Procedures.

In-Transit Handling Guidance Support to the Logistics Delivery Ops and Carriers

Qualifications

Master\xe2\x80\x99s degree in Thermal Engineering preferred.

Bachelor\xe2\x80\x99s degree, with proven experiences in Pharmaceutical Logistics, Thermal Engineering, Transportation or Supply Chain management in an international environment with experiences on temperature controlled/cold chain logistics and Transport Qualification.

In depth knowledge of a broad range of controlled temperature shipping solutions, components, systems, monitoring equipment, best practices and governing regulations.

In depth understanding of the regulatory guidelines impacting the requirements for qualifying and utilizing temperature control shipping systems

General knowledge of cold chain and cold chain shipment requirements.

Understand the concepts of product label claim and stability data and how to apply to the qualification process.

Understanding of processes used in development and qualification of controlled temperature shipping systems.

Proven project management and complex problem-solving skills

Impeccable technical writing skills

Ability to effectively manage and influence cross functional teams.

Ability to create visual keys to summarize a complex problems/ship scenarios.

Effective verbal and written communication via various channels such as email, teams chat, WebEx and Teams meetings.

Can evaluate the latest technology advances and apply industry principles and applications.

Can determine areas of potential risk to business success and generate gap analysis.

Subject matter expert in relevant materials, design and principles

Technical functional skills:

Can analyze operational process problems and provide support in determining appropriate corrective and preventative actions.

Demonstrate knowledge through practical application.

A propensity to pursue goals with energy and persistence.

Willingly share information and ideas with colleagues

Can articulate the issues and solutions to both the team and to senior management.

Maintains clear communication with customers (internal and external) and monitors customer expectations.

Nice-to-Have

Master\'s degree Thermal Engineering preferred.

Strong leadership acumen with the ability to lead cross functional meetings to drive strategic decision-making.

Must be detailed oriented with the ability to translate regulatory requirements into logistics strategy.

Ability to work with multi-cultural teams and collaborative environment.

Ability to work in a matrixed organization.

Interacts with others in a transparent, honest and authentic fashion. Ensures stakeholders are confident of one\'s intentions as well as those of the organization.

Understands and acknowledges the differing needs of stakeholders and works to achieve success in a mutually beneficial manner.

Highly organized and ability to prioritize activities on a daily basis.

Work Location Assignment: UK and EU Site or Remote

The closing deadline for applications is July 9th.

All applicants must have the relevant authorisation to live and work in the UK / EU as applicable.

Purpose

Breakthroughs that change patients\' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let\xe2\x80\x99s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms \xe2\x80\x93 allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

Logistics & Supply Chain Mgmt

Pfizer