What are the responsibilities and job description for the Transport Qualification Manager position at Pfizer?
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
E xisting 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
- Last Date to Apply: November 11, 2021
- 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.