Premier·ère Adjoint·e – Gouvernance de la qualité médicale / Medical Quality Governance (MQG) Senior Associate

Pfizer•Kirkland, QC

2d•$69,750 - $116,250•Hybrid

About The Position

The Medical Quality Governance (MQG) Senior Associate supports Medical Quality, Audit/Inspection Readiness and Risk Mitigation across all Medical Affairs’ therapeutic areas/categories for Pfizer Country Medical Operations. The MQG Senior Associate scope spans the local areas that are in scope of the Global Medical Affairs Quality Oversight Committee (MA QOC) and Cross-Functional Processes with medical involvement or inspection risk, based on the agreement with the Business Process Owner (BPO), International Medical Quality Governance (IMQG) and/ or country needs. The MQG Senior Associate receives functional oversight from the in-country Senior MQGM. The MQG Senior Associate is expected to interact closely with the in-country Medical Organizations, the Platform Line organizations, other Quality and Compliance representatives (e.g., Commercial Quality), and may participate in relevant country medical and quality / compliance teams or communities.

Requirements

University Degree (e.g., bachelor’s in health sciences)
Knowledge and understanding of document management in a regulated environment
Knowledge and understanding of Quality systems, processes, audits and inspections
Ability to work to tight timescales and prioritize own work.
Fluency in English. Bilingualism is an asset (French and English)
Project management-related skills
Ability to work independently
Excellent interpersonal, organizational and communication skills (both verbal and written)
Strong analytical and systematic skills with a process-oriented mindset; a problem solver focused on delivering results.
Experience in using a range of digital platforms
Confident and competent with digital compliance requirements.

Nice To Haves

Bilingualism (French and English) is an asset

Responsibilities

Support local Level 1 Medical Quality Oversight and Business Support at the market level
Contribute to 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])
Support the execution of Global Quality Plans. Collaborate to the development and maintenance of the Country Operational Plan, as applicable
Demonstrate MQG value proposition to internal stakeholders and external customers
Identify and report adverse events and product complaints as per Corporate and Regulatory standard procedure, including Your Reporting Responsibilities (YRR) training.
Support continuous medical inspection readiness efforts in collaboration with applicable headquarters inspection management teams, Medical Affairs therapeutic areas/categories, and Platform Line representatives
Assist with the development and maintenance of the in-country Regulatory Inspection Site Notification Plan
Provide support for the coordination of Regulatory Quality Assurance (RQA) Pfizer Country Office (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
Assist with the maintenance of professional records for Medical Affairs colleagues.
Support effective management of Quality Events (QE) and CAPAs for PCO scoped QEs within MQG remit and act as the Business Line Quality Group role
Assist with the monitoring of PCO QEs and CAPA performance
Collaborate with local QMS01 expert(s) and build PCO awareness on issue escalation & remediation requirements in partnership with other quality lines (e.g., CQ).
Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the medical Quality Management System (QMS)
Contribute to the development, implementation, and maintenance of in-country controlled documents within the scope of QMS04-GSOP and within MQGM remit in collaboration with relevant Subject Matter Experts (SME)
Act as local expert on QMS04-GSOP and ensure local controlled clinical and medical documents (LCMCDs) within MQGM remit follow 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 Policies/SOPs/Work Instructions and related training materials offering the country perspective and local impact.
Act as a local Subject Matter Expert on QMS07-GSOP, local training management and Pfizer’s Global Learning Management System
Assist local Senior MQGM with development & maintenance of local job roles (to match the Global roles or stand-alone job roles) based on Canadian training needs
Support assignment of local/global job roles to respective groups accordingly
In collaboration with Senior MQGM and local Management, identify additional training needs on quality-related areas (in addition to the Learning Management System mandatory requirements in place); facilitate / support / conduct of additional training for identified areas
Supports training completion compliance for in-country Medical Affairs, where needed.
Participate in, and sometimes lead, ad hoc projects initiated by the MQG Team, to assist the effectiveness of the team, utilizing specialist knowledge of global and local electronic systems and processes.