Transport Qualification Manager

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Job description

Why Patients Need You

Our manufacturing logistics and supply team makes sure that customers and patients have the medicines they need, when they need them. You'll help bring medicines to the world even faster by embracing challenges, imagining what's possible and taking action.

What You Will Achieve

• 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 dossier

How You Will Achieve It

New Product Launch 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's

• 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

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 TCL Functional leads

• Ensures logistics compliance with regional regulatory requirements where accountable

Distribution Warehouse Operational Support

• Responsible for doing tech-transfer 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

Technical Skills

• Master's degree with focus in thermodynamics preferred

• Minimum of Bachelor's degree, 3-5 years 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.

• 3-5 years of experience working with regulatory bodies

• In depth knowledge of a broad range of controlled temperature shipping 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

• 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

PHYSICAL/MENTAL REQUIREMENTS

• 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

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be able to work in a global environment across multiple time zones

• Up to 25% travel

• Nonstandard business hour support (e.g. weekends) as required

OTHER DETAILS

• Eligible for Relocation Package

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Logistics & Supply Chain Mgmt

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