Medical Quality and Oversight Manager

1 week ago

Makati City, National Capital Region, Philippines Pfizer, S.A. de C.V Full time

We're in relentless pursuit of breakthroughs that change patients' lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer's purpose – Breakthroughs that change patients' lives – we have established a clear set of expectations regarding "what" we need to achieve for patients and "how" we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

The Medical Quality Governance Manager (MQGM), reports to the Global Medical Quality Governance (GMQG) Asia Cluster Team Lead and is accountable for successful execution of local quality related activities and risk mitigation for identified medical processes for Medical in Worldwide Medical & Safety (WMS) and Business Unit (BU) Medical Affairs.

As an active member of the GMQG Regional GMQG EM-China group, as well as a liaison with the Pfizer Country Office (PCO) Medical leadership team, the MQGM will continuously implement strategic medical quality initiatives within assigned market(s). The MQGM is accountable for implementing aspects of the GMQG framework and operating model aligned with the Medical Affairs Quality Oversight Committee (MA QOC) and supports the execution, tracking, and remediation of quality plans and communicates the results to country medical leadership for all assigned countries.

This role delivers medical quality oversight and quality consultation activities locally and is accountable for audit and inspection readiness. The MQGM draws upon best practices and identifies innovative ways of working and uses continuous improvement efforts to continually strengthen local quality and overall adherence with medical processes to help ensure a state of control for relevant business processes.

The MQGM works with the GMQG Asia Cluster Team Lead to drive consistency and enable increased communication and information sharing across Regional GMQG Leadership, Medical Excellence, and PCO colleagues, while promoting a culture of quality locally.

ROLE RESPONSIBILITIES

GMQG Processes, Services and Operating Model

  • Contribute to local, regional and global quality strategic initiatives in partnership with GMQG leadership
  • Lead 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 needed
  • Drive 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 requirements
  • Oversee 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 markets
  • Partner 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 documents
  • Execute monitoring procedures aligned with global and/or local quality plans and reports findings to GMQG leadership
  • Ensures 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 needed

AUDIT AND INSPECTION

  • Lead continuous audit/inspection readiness efforts in collaboration with applicable headquarters' inspections management teams, Business Units, and Platform Line representatives
  • Represent 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 plans
  • Support local regulatory authority inspections as per Pfizer standards, depending on inspection scope
  • Monitor audit/inspection outcomes for assigned markets, share learnings, flag areas of concern to Asia Cluster Team Lead and PCO Medical Leadership

SOPs, PROCEDURES AND TRAINING OVERSIGHT

  • Develop (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 accordingly
  • Provide input to draft Global /SOPs /Policies/Working Instructions and related training materials offering the country perspective and local impact
  • Ensure local training curricula are maintained in line with Pfizer standards
  • Support training compliance reporting for local colleagues

BASIC QUALIFICATIONS

  • Advanced academic qualifications in science, health, business or technology- related field preferred, with equivalent relevant professional experience
  • 5+ years of pharmaceutical industry experience managing multiple and highly complex projects
  • 3-5 years of experience in the fields of Internal Audit, Assurance, Risk Management, Quality Standards, Compliance, Safety, Medical Affairs, including experience with highly matrixed teams
  • Knowledge of relevant Medical Affairs processes, compliance, regulatory requirements and other global/local evolving legislation
  • Experience creating and executing quality plans and risk mitigation strategies for medical activities
  • Excellent organizational, analytical, strategic, interpersonal, written and oral skills
  • Self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.

PREFERRED QUALIFICATIONS

  • Demonstrated strength in influencing and negotiation skills and ability to communicate effectively and build relationships at all levels of the organization
  • Ability to maintain a calm demeanor through challenging and complex situations
  • Demonstrated success in developing/redesigning processes and measuring effectiveness and efficiency

PHYSICAL/MENTAL REQUIREMENTS

NA

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Periodic travel to other Pfizer locations may be required, teleconferences outside of normal working hours

#LI-PFE

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs
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