Role summary:

　　Actively contributes as part of the ESOQ Tier 2 structure to ensure that Pfizer network of External suppliers / CMO's / partners are supported to deliver high quality products, on time, and in compliance with all established standards and agency guidelines/applicable GMP regulations. Some regional specific roles may have region specific responsibilities.

　　Responsible for:

　　Managing all aspects related to product quality or compliance for a portfolio of external contract manufacturers (CMO) and suppliers that supply materials/product(s) to Pfizer according to established procedures.Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained.Supporting internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors - (RQA audits or Regulatory Inspections) as applicableSupporting internal and external partners with Compliance Assessments to ensure current GMP adherenceSupporting onboarding activities of new CMO's or product launches within the portfolio as applicable.Make product Quality decisions leveraging comprehensive 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 requirementsProvide Quality Leadership within the cross functional virtual site operating teams (VSOT).Partner with colleagues to develop and negotiate quality agreements.On time disposition of Product.May identify, develop, and implement continuous improvement initiatives related to ESOQ processes to ensure compliance with the latest internal and external standards.Ensuring the adequate tracking and documentation of all required quality related actions in the relevant system(s) and ensuring that all required escalation processes are followed.Leading and supporting investigations, market complaints, risk assessments in support of products within your portfolio. Connect with SMEs where neededWorking independently, receiving instructions primarily on unusual or complex problems.Building, maintaining, and developing relationships with key stakeholders, both internal and external to Pfizer.Supporting ESOQ leadership on other tasks as required

　　Where required for Regional Activities:

　　China

　　Measures for the Supervision and Administration of Pharmaceutical Production, Person In Plant based on quality risk both for production and testingManagement of MAH Quality systems, including and not limited to Site Self-inspection, Local Document & record, Procedures, Training, new Regulations InterpretationHost and manages BoH inspections on behalf of MAH for Pfizer investmentVendor management including directly managed vendor and indirectly managed vendor (materials suppliers managed by CMO)

　　Japan

　　Support of "The Pharmaceutical Officer" and "The Quality Assurance Officer" as Quality Assurance section of Market Authorization Holder based on Japanese Pharmaceuticals Law (GQP) Manage and control Quality Related Information in case of Product Recall, Supply Shortage, and serious quality issue for Marketing Authorization Product based on Japanese Pharmaceuticals Law (GQP)Oversight not only direct manage CMO but also upstream in-direct manage CMO which is described in Approved Form based on Japanese Pharmaceuticals Law (GQP)

　　Basic Qualification:

　　Minimally Bachelor of Science Degree, Pharmacy, Engineering, or related technical disciplineMinimally 5 years experiences in Pharmaceutical or Medical Device Quality Assurance roles with direct responsibility for product quality decisions and /or 10 years' experience in the pharmaceutical or medical device industry.Advanced computer skills for MSOffice and good knowledge of enterprise systems such SAP, QTS, Vault, PDM, Documentum platformsProficient in English (written and spoken)Strong technical writing skillsStrong verbal, written communication, and presentation skillsDemonstrated personal leadership to work in virtual teams and in cross functional projects/initiativesDemonstrated experience managing complex quality and compliance activitiesProblem solving attitude and open to innovationDemonstrated managerial/organizational skillsTakes initiatives and is proactive, persistentGood organizing and planning skills and a high sense of urgencyDemonstrated ability to act and work independently and to report items as required to line managerDemonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practicesDemonstrated technical know howProven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.

　　Preferred Qualifications:

　　Master's degree and + 10 years relevant pharmaceutical experience.Demonstrated experience in pharmaceutical manufacturing activities (API, DP, Biotech, Oral Solid Dosage, Aseptic) applicable to the roleExperience with external suppliers/contractorsExperience on managing investigations (DMAIC, 6sigma, ...)Candidate demonstrates the ability to influence and collaborate with peers

　　Other info:

　　Reporting line - ESOQ Quality Operations Lead (Team Leader)Up to 20% travel

　　Work Location Assignment: Flexible

　　Additional Information

　　In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.Please note there is no relocation support available for this position

　　How to apply

　　Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!

　　Purpose

　　Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

　　Digital Transformation Strategy

　　One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

　　Equal Employment Opportunity

　　We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

　　Quality Assurance and Control

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