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Medical Quality Oversight Manager

Client of Manpower Middle East

Posted on August 6, 2018

3 - 4 years United Arab Emirates - United Arab Emirates

Bachelor of Science. Any Nationality

Opening 01

Job Description

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• 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 the Clients Country Medical Operations.
SCOPE
• The MQOM scope spans the local areas that are defined by the Medical Quality Management System (QMS), where these impact in-country Medical Operations. This may include lines beyond Medical, e.g., Commercial, where these are involved in regulated activities governed by the Medical QMS.
Geographic area covered by the role
Algeria, Tunisia, West Africa, NEAR, Morocco
MAIN REPONSIBILITIES / DUTIES
This role will parner and support the Country MQOLs (Medical Quality Oversight Liasons) in the 5 countries under the scope of the MQOM to ensure the Medical Quality Responsibilities are covered. Here are the MQO responsibilities at country level:
Quality Mgmt
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 the Client's 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 Client's 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 Mngt and Escalation
• Upon identification of risk or potential quality issue, escalate to management as per Client's standards
• Drive effective management of quality issues and CAPAs. Act as the Business Line Quality Group role for PCO scoped SQEs, within MQO remit.
Training
• Ensure training requirements are included in the appropriate curricula
• Ensure local curricula are maintained in line with the Client's standards
• Facilitate local training compliance reporting to in-country Medical Management
• Act as a local Subject Matter Expert on local training management and the Client 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
Quality Reviews
?
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
? REQUIRED SKILLS
Education & Experience
• 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

Desired technical and behavioral skills:
• Fluency in English
• Expertise in managing multiple complex projects
• Consultancy skills
• Ability to work independently
• Able to lead withou 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
• Displays sensitivity to manage relationships and ability to build collaborative working relationships with colleagues and associates both within and external to the organization;
• Collaborates efficiently across functional and country boundaries, respecting communication, functional priorities and cultural differences in interpersonal relationships


Pharma / Biotech / Clinical Research

Quality / Testing / QA / QC / Inspector

Desired Candidate Profile


Keywords

Project management Analytics Auditing LMS Continuous improvement Subject Matter Expert Regulatory compliance Training management Management audit Internal audit

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Client of Manpower Middle East

ManpowerGroup is a leading global name in innovative workforce solutions and caters to the human resource requirements of both small and large organizations across various industries. Founded in 1948, ManpowerGroup has expanded its reach from one office to a strong international network of 3, 500 of fices in 80 countries. The company involves working with over 400,000 clients and 304 million associates every year and assists them in increasing the productivity of their businesses by providing them with human resource and services like training & development, recruitment & assessment, career management and workforce consulting.



The company has a vision to be a leader in the creation and delivery of innovative workforce solutions and services. The Group cares about its people and offers them various opportunities to develop their careers through proper training and planning.

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