General Summary

This Director level role holds Global QO responsibility for oversight and operational support for the worldwide transportation activities related to Pfizer's current and future portfolio, including different C19 vaccine formulations and Gene Therapy products.

This is a key, senior position, providing leadership over a global, virtual team of quality professionals.

The incumbent will proactively interact with and support Intercompany Operations (IO) stakeholders, Logistic Solutions and Compliance (LSC), Logistic Delivery Operations (LDO) and Digital to ensure that all Pfizer products are transported under the appropriate conditions and according to global Board of Health (BoH) expectations. In addition, the incumbent will liaise with quality teams in PGS sites, External Supply Quality (ESQ), Supply Chain Quality (SCQ) and Logistic Center Quality (LCQ) to support the introduction of new distribution and transportation models. This role has responsibility for the exploration, evaluation, qualification, onboarding and monitoring of suppliers in the transportation area, such as freight forwarders, ocean/airlines, suppliers of monitors, shipper boxes etc.

The role provides the quality authority for lane characterization, qualification of the shipping solutions (active and passive), lane procedures and associated controls and works with the quality function of pick and pack locations to ensure that product is packaged appropriately for transportation. The role leads complex quality investigations in the transportation area and ensures inspection readiness for transportation in support of PCO's, LCs and PGS sites across the globe.

Principal Duties & Responsibilities (include but not limited to):

• Provides strategic direction to a team of quality professionals across global locations
• Ensure that appropriate resources are in place and are effectively organized to support compliant transportation and new transportation models
• Provides senior oversight to a cross functional team of quality professionals that are located in different parts of the world.
• Supports colleague development, performs talent reviews and develops plans for succession
• Ensures an effective process for due diligence, qualification and onboarding of IO Suppliers is in place and that execution is performed accordingly.
  • Performs due diligence audits and reports back the findings to quality senior management to endorse the use of the suppliers
  • Negotiates quality agreements
  • Onboards the new suppliers on Pfizer systems such as QTS, SMS, CLM

• Provides an effective routine quality oversight of IO suppliers
  • Ensures compliance with GDP and Pfizer's expectations
  • Develops plans to address identified gaps, monitor remediation and CAPA effectiveness
  • Conducts regular reviews of quality performance with the suppliers and active participation at associated Business Review Meetings.
  • Supports investigations related temperature excursions, damages and theft that are caused by the processes of suppliers

Educational Qualification & Experience Required

• A minimum of a Bachelor degree in Sciences or Engineering
• Significant Manager to Director level experience is required within the pharmaceutical industry - preferably within the Quality and/or Compliance fields
• Able to work well in a matrix organization set up and influence key stakeholders. Good interaction and clear communication skills with multiple stakeholders is required.
• Worked extensively with contractors and service providers.
• Fluent in English (spoken and written), ability to speak and read other languages will be an added advantage.
• Excellent Quality Decision Making skills
• Experience with formation and management of effective teams in a virtual environment
• Good Knowledge of EU Good Distribution Practices
• Experience with maintenance of budgets