ROLE RESPONSIBILITIES GMQG Processes, Services and Operating ModelContribute to local, regional and global quality strategic initiatives in partnership with GMQG leadershipLead the development and execution of country quality strategic initiatives based on risk and business needs, in close collaboration with Local Medical Management, GMQG Leadership, BU Markets and other key stakeholders (e.g., Platform Line management [Safety, Regulatory]Participate in local Risk Management Forums, governance boards, and appropriate regional governance structures, as neededDrive and oversee effective management of Serious Quality Events/Quality Events (SQE/QE) and Corrective and Preventive Actions (CAPAs) in GMQG scope for assigned markets, as per Pfizer requirementsOversee SQE/QE and CAPA performance within assigned markets and ensure performance is within required standards.Enable implementation and regular reporting of medical quality performance analytics, monitor and drive quality performance for the assigned marketsPartner with GMQG Asia Cluster Team Lead and Business Process Owners (BPOs) to drive implementation of policies and procedures in scope of GMQG in assigned markets, and ensure that proper controls and oversight is in place for local country medical documentsExecute monitoring procedures aligned with global and/or local quality plans and reports findings to GMQG leadershipEnsures all non-compliance findings are addressed with Pfizer colleagues for remediation and analyzes results for trends that may require escalation because of systemic issues Partners with various cross-functional key stakeholders to lead and/or participate in ad hoc special projects, as neededAUDIT AND INSPECTIONLead continuous audit/inspection readiness efforts in collaboration with applicable headquarters’ inspections management teams, Business Units, and Platform Line representativesRepresent GMQG and serve as the point of contact during all PCO audits and inspections for relevant business processes across the assigned markets and serve as the escalation point to resolve local audit related queries and manage remediation plansSupport local regulatory authority inspections as per Pfizer standards, depending on inspection scopeMonitor audit/inspection outcomes for assigned markets, share learnings, flag areas of concern to Asia Cluster Team Lead and PCO Medical LeadershipSOPs, PROCEDURES AND TRAINING OVERSIGHTDevelop (and/or support the development), implement and maintain relevant in-country controlled documents within the scope of QMS04 in collaboration with relevant Subject Matter Experts,Ensure local controlled documents within GMQG remit are compliant with applicable Pfizer policies and procedures and regulatory requirements.Facilitate local implementation of global SOPs and ensure relevant communication is cascaded accordinglyProvide input to draft Global /SOPs /Policies/Working Instructions and related training materials offering the country perspective and local impactEnsure local training curricula are maintained in line with Pfizer standardsSupport training compliance reporting for local colleaguesBASIC QUALIFICATIONS Advanced academic qualifications in science, health, business or technology- related field preferred, with equivalent relevant professional experience5+ years of pharmaceutical industry experience managing multiple and highly complex projects3-5 years of experience in the fields of Internal Audit, Assurance, Risk Management, Quality Standards, Compliance, Safety, Medical Affairs, including experience with highly matrixed teamsKnowledge of relevant Medical Affairs processes, compliance, regulatory requirements and other global/local evolving legislationExperience creating and executing quality plans and risk mitigation strategies for medical activitiesExcellent organizational, analytical, strategic, interpersonal, written and oral skillsSelf-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.PREFERRED QUALIFICATIONSDemonstrated strength in influencing and negotiation skills and ability to communicate effectively and build relationships at all levels of the organizationAbility to maintain a calm demeanor through challenging and complex situationsDemonstrated success in developing/redesigning processes and measuring effectiveness and efficiency Work Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Quality Assurance and Control#LI-PFE