Pfizer Medical Quality Oversight Manager Jobs in Nigeria
Pfizer Medical Quality Oversight Manager Jobs in Nigeria
Pfizer - Good health is vital to all of us, and finding sustainable solutions to the most pressing health care challenges of our world cannot wait. That's why we at Pfizer are committed to applying science and our global resources to improve health and well-being at every stage of life.
We strive to provide access to safe, effective and affordable medicines and related health care services to the people who need them.
The Medical Quality Oversight Manager (MQOM) role drives quality management, compliance, inspection readiness, training, process improvements, and oversight needed to ensure high quality performance of Pfizer Country Medical Operations.Drive the local Country Quality Management System
Contribute to regional and global quality strategic initiatives in partnership with Global MQO leadership
Lead the development of country quality strategic initiatives based on risk and business needs, in close collaboration with Local Medical Management, MQO Leadership, BU Markets and other key stakeholders (e.g., Platform Line management Safety, Regulatory)
Development and maintenance of Country Quality Plan
Participation in Country Medical Council
Demonstrate value proposition of MQO to internal stakeholders and external customers.
Quality consulting activities (e.g., answer to queries on medical quality requirements, CEPs, Promotional Compliance)
Ensure appropriate connections to internal stakeholders across lines
Participate in appropriate regional governance structures (e.g. Promotional Materials Steering Group)
Audits & Inspections:
Lead continuous inspection readiness efforts in collaboration with applicable headquarters inspections management teams, Business Units, and Platform Line representatives
Communicate relevant Inspection / audit trends to respective country stakeholders, drive that applicable actions are taken to address country gaps
Develop and maintain the in-country Regulatory Inspection Action Plan. Lead, coordinate or support local regulatory authority inspections as per Pfizer standards, depending on inspection scope
Coordinate internal audits within the scope of in-country Medical Operations, including management of audit Corrective & Preventive Actions (CAPAs). Support external inspections as appropriate
Support maintenance of professional records for Medical colleagues
SOPs & Other Procedures:
Support the process for impact assessment of new or revised regulatory requirements and legislation impacting the Medical Quality Management system
Develop (and/or support the development), implement and maintain in-country controlled documents within the scope of QMS04 in collaboration with relevant Subject Matter Experts, meeting the business needs for the area under the scope of MQOM
Ensure local controlled documents within MQO remit are in compliance 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
Quality Issues Management and Escalation:
Upon identification of risk or potential quality issue, escalate to management as per Pfizer standards
Drive effective management of quality issues and CAPAs. Act as the Business Line Quality Group role for PCO scoped SQEs, within MQO remit.
Ensure training requirements are included in the appropriate curricula
Ensure local curricula are maintained in line with Pfizer standards
Facilitate local training compliance reporting to in-country Medical Management
Act as a local Subject Matter Expert on local training management and Pfizer’s Global Learning Management System
Ensure country colleagues have sound knowledge of regulatory requirements: in collaboration with local Management, identify additional training needs (in addition to P2L mandatory requirements); facilitate / support / conduct of additional training for identified areas.
Support training compliance reporting for regional colleagues
Identify areas for quality reviews in collaboration with in-country Medical Management and Platform Lines, and Regional Medical Quality Oversight, as appropriate
Conduct quality reviews and report on results or defined quality analytics to in-country Medical Management, Platform Lines and Regional Medical Quality group, as appropriate
Scientific or technical degree is preferred: BS or MS and over 3 years’ experience in compliance/SOP management, auditing, QA/QC or related field
Understanding of the local promotional compliance environment
Appreciation of the regulatory compliance issues relating to the local medical function
Previous experience in a role involved in the drug development process is valued
Supervisory experience in a matrixed organization is valued
Knowledge of training design and tools and experience in applying training methodology is considered a plus.
How to Apply
Interested and qualified candidates should apply online by 30th January, 2019.
For more information and job application details, see; Pfizer Medical Quality Oversight Manager Jobs in Nigeria
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