Medical Quality Officer
The Medical Quality Officer role drives quality management, compliance, inspection readiness, training, process improvements, and oversight needed to ensure high quality performance of Pfizer Country Medical Operations.
- Contribute/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
- 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)
- Participate in/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
- Participate in/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
- Drive the local impact assessment of new and revised local regulatory requirements and ensure these are appropriately documented in in-country controlled documents within MQO remit
- 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
- 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
- Secure Promotional Compliance and adherence to related local requirements (e.g. ENLI)
- Support or drive implementation of quality related projects as agreed with local management
- FCPA/Promotional Compliance related approver roles
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 and Danish
- 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
- 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
- High level of IT user skills
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
A career at Pfizer offers opportunity, ownership and impact.
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