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PURPOSE & SCOPE
ORGANIZATIONAL RELATIONSHIPS
MAIN RESPONSIBILITIES / DUTIES
Quality Management:
Audits & Inspections:
Issue Escalation and Quality Event Management:
Management of SOPs & Other Procedures:
Training:
Monitoring:
REQUIRED SKILL SET
Education & Experience:
Desired technical and behavioural skills:
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
- The Medical Quality Manager (MQM) drives medical quality, audit/inspection readiness and risk mitigation within in-country Medical Affairs BU.
- The MQM scope spans the local areas that are in scope of the Global Medical Affairs Quality Oversight Committee and Cross-Functional Processes with medical involvement or inspection risk, based on the agreement with the Business Process Owner, International Medical Quality (IMQ) and/ or country needs.
ORGANIZATIONAL RELATIONSHIPS
- The MQM 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).
MAIN RESPONSIBILITIES / DUTIES
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, IMQ, and other key stakeholders (e.g., Platform Line management [Safety, Regulatory]).
- Execute Global Quality Plans. Develop and maintain Country Operational Plans as applicable.
- Demonstrate MQ value proposition to internal stakeholders and external customers.
Audits & Inspections:
- Lead 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 IMQ remit, depending on scope), including management of audit Corrective & Preventive Actions (CAPAs).
- Support Corporate Audit requests within scope of IMQ 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:
- Drive effective management of quality events (QE) and CAPAs for PCO scoped QEs within MQM remit and act as the Business Line Quality Group role.
- Monitor and drive PCO QEs and CAPA performance.
- Act as local QMS01 expert and build PCO awareness on issue escalation & remediation requirements in partnership with other quality lines.
Management of SOPs & Other Procedures:
- Develop or support the development, implementation, and maintenance of in-country controlled documents within the scope of QMS04 and within MQM remit in collaboration with relevant Subject Matter Experts (SME).
- Act as local expert on QMS04 and ensure local controlled clinical and medical documents within MQM 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
- Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the medical Quality Management System (QMS).
Training:
- Ensure local training requirements in MQM remit are included in the appropriate curricula.
- Ensure local curricula in MQM 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 IMQ as appropriate.
- Execute monitoring activities as defined by applicable global quality plans.
REQUIRED SKILL SET
Education & Experience:
- Scientific or technical degree is preferred: BS or MS and over 3 years' experiencein compliance/SOP management, auditing, QA/QC, or related field
- Understanding of the local promotional compliance environment
- Appreciation of the compliance issues relating to the local medical function
- Experience in a matrixed organization is valued
Desired technical and behavioural skills:
- Fluency in English
- Expertise in managing multiple complex projects
- 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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
Pfizer New York, New York, USA Office
Pfizer Hudson Yards Office
66 Hudson Blvd E, Suite 20, New York, NY, United States, 10001
Pfizer Madison, New Jersey, USA Office
1 Giralda Farms, Madison, NJ, United States, 07940
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