External Supply Operations Quality Manager (Fixed Term Contract)
Randstad inhouse services, specialty pharma, is looking for a resource on behalf of Pfizer srl to be included in the Rome office in the role of External Supply Operations Quality Manager.
Responsibilities: - The ESOQ Manager is accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements.
- This is highly independent position operating with minimal supervision, interacting with high levels of management both at contract manufacturers and within Pfizer.
- (S)he will operate as spokesperson for ESOQ and will focus on developing relationships, independently negotiating, developing and communicating Pfizer quality requirements with contract manufacturers.
- ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e. g.
External Supply, Regulatory, Technical Support, Quality, PGS sites and R&D) and will lead virtually-based cross functional teams.
- Initiate, review and approve regulatory changes through Pfizer enterprise system (i. e PDM) for changes initiated by or impacting ESOQ managed contractors.
- Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.
- Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
- As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meeting for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.
- Support and Perform Lot Disposition for Biotech semi finished and finished products (if applicable).
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