Senior AssociateExternal SupplyOperationsQuality (ESOQ)

Role Description:

• The Global External Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives." 

• External SupplyOperationsQuality (ESOQ) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.

• ESOQis responsible forthe Quality& Regulatorymanagement of approximately 300 contract manufacturers, packagers, and supply partners globally.

Responsibilities:

• Accountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured & testedin accordance withc-GMPs, the registration file and anyadditionalcountry specific requirements.

• Provide Quality Leadership and act as regulatory expert within the VSOT, advising of regulatory strategy and potential supply constraints if any.

• Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems aremaintained.

• Supportinternalandexternalpartners with auditing activitiesrelatedto ESOQ activities, or activitiesata portfolio of contractors-(RQA audits orregulatoryinspections)asapplicable

• Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence

• Support onboarding activities of new CMO's or product launches within the portfolio as applicable.

• Make product Quality decisionsleveragingcomprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.

• Influence quality decision making in line with industry and Pfizer requirements

• Partner with colleagues to develop and negotiate Quality Agreements.

• Initiate,reviewand approve regulatory changes throughPfizerenterprise system (i.ePDM) for changesinitiatedby orimpactingESOQ managed contractors.

• Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Productregistrationsand Post approval variations.

• Main point of contact for Global ChemistryManufacturing & Controls (GCMC)dept.or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) forregulatoryactivities involving the ESOQ contractors.

• As the Regulatory Expert,participatein Virtual Site Operating Teams (VSOT) or similarmeetingsfor ESOQ managed contractors and if needed,participatein Site Quality visits at the contractors.

• Support and Perform Lot Disposition for Biotechsemi-finishedand finished products (if applicable).

Qualifications:

• Minimally 5years of experience in GXP setting and/or Regulatory Affairs role (Pertinent Master's degreerequired).

• Expertisein external suppliers/contractors, Change Management and Regulatory

• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS,PDM,Documentum platforms

• Command of English languagerequiredand multi-lingual is a benefit

• Strong verbal and written communication including presentation skills

• Shows strong negotiation skills and is diplomatic in communication with internal and external customers

• Demonstrated ability to manage multiple projects and priorities

• Demonstrated ability to prioritize work, to act and work independently and to report items asrequiredto Team leader

• Demonstratedexcellentorganizationskills

• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor

• Developing personal leadership to manage cross functional projects

• Developingabilitytoresolveconflicts

• Takes initiatives and is proactive, persistent

• Has a broad GMP and technicalknow-howto handle emerging issues

• Able to report remotely and deliver work independently