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The Role
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. The M edical Quality Governance specialist (MQG S ) drives medical quality, audit/inspection readiness and risk mitigation within in-country TA Medical Affairs. T he MQG S is expected to interact closely with the in-country Medical Affairs, the Platform Line organizations, other quality and compliance representatives (e.g., Commercial Quality, Supply Chain/Product Quality, Compliance) and is a member of the relevant country medical and quality/compliance leadership teams or communities (e.g. Country Medical Council).
Medical Quality Governance(MQG) 팀은 의학부 직원의 활동 전반에 대한 Level 1 Quality를 담당하는 조직입니다. 주요 역할은 의학부 직원의 Medical‑to‑Medical communication 및 PMS/RWE study 관련 활동의 quality를 관리• 지원하는 것입니다. 해당 포지션은 Medical Affairs 경력, RWE/PMS 연구 경험 및 GCP 관련 경험을 보유한 분, 그리고 이에 대한 quality 업무 경험이 있으신 분을 우대합니다. 한편, GMP 관련 업무는 본 포지션의 범위에 포함되지 않으므로 우대 요건으로 고려되지 않습니다.
What You Will Achieve
In this role, you will:
[Quality Management]
[ Audits & Inspections ]
[ Issue Escalation and Quality Event Management SOPs & Other Procedures ]
[ Training ]
[ Monitoring ]
[ PCO-Specific Responsibilities ]
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Pfizer 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
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety. The M edical Quality Governance specialist (MQG S ) drives medical quality, audit/inspection readiness and risk mitigation within in-country TA Medical Affairs. T he MQG S is expected to interact closely with the in-country Medical Affairs, the Platform Line organizations, other quality and compliance representatives (e.g., Commercial Quality, Supply Chain/Product Quality, Compliance) and is a member of the relevant country medical and quality/compliance leadership teams or communities (e.g. Country Medical Council).
Medical Quality Governance(MQG) 팀은 의학부 직원의 활동 전반에 대한 Level 1 Quality를 담당하는 조직입니다. 주요 역할은 의학부 직원의 Medical‑to‑Medical communication 및 PMS/RWE study 관련 활동의 quality를 관리• 지원하는 것입니다. 해당 포지션은 Medical Affairs 경력, RWE/PMS 연구 경험 및 GCP 관련 경험을 보유한 분, 그리고 이에 대한 quality 업무 경험이 있으신 분을 우대합니다. 한편, GMP 관련 업무는 본 포지션의 범위에 포함되지 않으므로 우대 요건으로 고려되지 않습니다.
What You Will Achieve
In this role, you will:
[Quality Management]
- Drive Level 1 medical quality oversight and business support at the market level.
- Lead the development of country medical quality strategic initiatives based on risk and business needs, in close collaboration with local medical management, IMQG, and other key stakeholders (e.g., Platform Line management [Safety, Regulatory]).
- Execute Global Quality Plans. Develop and maintain Country Operational Plans as applicable.
- Demonstrate MQG value proposition to internal stakeholders and external customers.
- Quality Consulting activities (e.g., answer to queries on medical quality requirements).
- Conduct a Self-inspection for safety management activities periodically (e.g., on a yearly basis) in accordance with local regulations (e.g., Enforcement Rule on Safety of Medicinal products).
[ Audits & Inspections ]
- Support continuous medical inspection readiness efforts in collaboration with applicable global inspections management teams, Business Units, and Platform Line representatives.
- Communicate relevant audit and inspection trends to respective country stakeholders, ensure that applicable actions are taken to address country gaps.
- Develop and maintain the in-country Regulatory Inspection Site Notification Plan.
- Coordinate Regulatory Quality Assurance Pfizer Country Organization (PCO) audits and vendor audits (vendor audits if in IMQG remit, depending on scope), including management of audit Corrective & Preventive Actions (CAPAs).
- Support Corporate Audit requests within scope of IMQG as appropriate .
- Support external inspections as appropriate in partnership with global inspection management teams.
- Support maintenance of professional records for Medical Affairs colleagues.
[ Issue Escalation and Quality Event Management SOPs & Other Procedures ]
- Drive effective management of quality events (QE) and CAPAs for PCO scoped QEs within MQGM remit and act as the Business Line Quality Group role.
- Monitor and drive PCO QEs and CAPA performance.
- Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the medical Quality Management System (QMS).
- Act as local QMS01 expert and build PCO awareness on issue escalation & remediation requirements in partnership with other quality lines.
- Develop or support the development, implementation, and maintenance of in-country controlled documents within the scope of QMS04 and within MQGM remit in collaboration with relevant Subject Matter Experts (SME).
- Ensure local controlled clinical and medical documents within MQGM remit follow applicable Pfizer policies and procedures and regulatory requirements.
- Facilitate local implementation of global Standard Operating Procedures (SOPs) and ensure relevant communication is cascaded accordingly.
- Provide input to draft Global SOPs, Policies, Work Instructions (WI ) and related training materials offering the country perspective and local impact.
[ Training ]
- Ensure local training requirements in MQGM remit are included in the appropriate curricula .
- Ensure local curricula in MQGM remit are maintained in line with Pfizer standards.
- Facilitate local training compliance reporting for in-country Medical Affairs where needed.
- Act as a local Expert on QMS07 and Pfizer's Global Learning Management System.
- In collaboration with local management, identify additional training needs on quality related areas (in addition to MEL mandatory requirements); facilitate , support , conduct of additional training for identified areas.
[ Monitoring ]
- Identify local areas for monitoring ( e.g. via quality reviews) in collaboration with in-country medical management and IMQG as appropriate .
- Execute monitoring activities as defined by applicable global quality plans.
[ PCO-Specific Responsibilities ]
- Support Business Continuity planning for Medical Management.
- Manage the filing and archiving of MQG related documents, as appropriate .
Here Is What You Need (Minimum Requirements)
- Scientific or technical degree is preferred: BS or MS and over 3 years' experience in compliance/SOP management, auditing, QA/QC, or related field
- Experience in In ter ventional / Non-international studies including PMS is highly preferred.
- Fluency in English
- Appreciation of the regulatory compliance issues relating to the local medical function
- Previous experience in medical affairs activities is valued
- Supervisory experience in a matrixed organization is valued
- Excellent technical writing, communication, and presentation skills
- Proficiency in Microsoft Office, Microsoft Project
- Experience in preparing and participating in audits and inspections
Bonus Points If You Have (Preferred Requirements)
- Expertise in managing multiple complex projects
- Consultancy skills
- Ability to work independently
- Able to lead without reporting line authority at senior level
- Project Management expertise
- Excellent verbal, written, and presentation skills
- Collaboration, interpersonal and facilitation skills
- Continuous Improvement and/ or organizational effectiveness expertise
- Display sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization
- Collaborate efficiently across functional and country boundaries, respecting communication, functional priorities, and cultural differences in interpersonal relationships
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Pfizer 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
What the Team is Saying
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Pfizer Compensation & Benefits Highlights
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Healthcare Strength — Official materials describe comprehensive medical, dental, vision, and mental-health support, plus fertility/family‑building and transgender‑inclusive coverage; eligible Pfizer medications are noted as available at no cost in U.S. plans. Wellness resources such as telehealth and preventative programs are also emphasized.
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Retirement Support — Company documents highlight a 401(k) with matching contributions plus an additional Retirement Savings Contribution beyond the match. Financial planning support and company‑paid life and disability insurance further bolster long‑term security.
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Leave & Time Off Breadth — Corporate pages and job postings describe paid vacation and holidays, caregiver leave, and paid parental leave for both parents. Materials also note that details can vary by role and location.
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The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Employees engage in a combination of remote and on-site work.
Typical time on-site:
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