Quality Manager

The key role of Pfizer SCQ is to establish and maintain an appropriate and sustainable Product Quality System and Quality Culture within Pizer and any contractor related to GMP/GDP activities, so that compliance with Pfizer and Regulatory authority expectations and protection of Pfizer patients/customers from any product quality risk are ensured. SCQ is the main point of contact for the investigation and resolution of all product quality issues discovered or originating in the PCO and for interacting with the relevant local stakeholders, PGS and local regulatory authorities on such issues. Coordinates and monitors the product quality and compliance activities at the PCO to ensure that current regulatory expectations are met and facilitates internal and regulatory GMP inspections. Acts as a qualified person responsible to local authorities and oversees Qualified person's activities for all Pfizer quality compliance issues, if needed.

Role description and Main responsibilities

Maintenance of the compliance to the local BOH regulations

• Coordinate the product quality and compliance activities at the PCOs, to ensure current BOH expectations are met.
• Act as the Qualified / responsible Person to local authorities or support Qualified Person activities for all Pfizer Product Quality Compliance issues in the market.