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Medical Quality Manager

3 - 7 years

0 Lacs

maharashtra

Posted:1 week ago| Platform: Shine logo

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Skills Required

compliance auditing qaqc project management verbal communication written communication presentation skills interpersonal skills continuous improvement organizational effectiveness relationship management collaboration sop management facilitation skills

Work Mode

On-site

Job Type

Full Time

Job Description

Role Overview: As the Medical Quality Manager (MQM) at our company, your main responsibility is to drive medical quality, audit/inspection readiness, and risk mitigation within the in-country Medical Affairs BU. You will be working closely with the in-country Medical Affairs, Platform Line organizations, and other quality and compliance representatives to ensure the highest standards of quality management. Key Responsibilities: - 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, collaborating with local medical management and other key stakeholders. - Execute Global Quality Plans and develop Country Operational Plans as applicable. - Lead continuous medical inspection readiness efforts in collaboration with global inspections management teams. - Communicate relevant audit and inspection trends to country stakeholders and ensure necessary actions are taken. - Develop and maintain the in-country Regulatory Inspection Site Notification Plan. - Coordinate Regulatory Quality Assurance audits and vendor audits. - Drive effective management of quality events (QE) and Corrective & Preventive Actions (CAPAs) for PCO scoped QEs within MQM remit. - Develop, implement, and maintain in-country controlled documents within the scope of QMS04. - Ensure local training requirements in MQM remit are included in the appropriate curricula and maintain local curricula in line with Pfizer standards. - Identify local areas for monitoring in collaboration with in-country medical management and execute monitoring activities as defined by global quality plans. Qualifications Required: - Scientific or technical degree preferred: BS or MS with over 3 years of experience in compliance/SOP management, auditing, QA/QC, or a related field. - Understanding of the local promotional compliance environment and compliance issues related to the local medical function. - Experience in a matrixed organization is valued. - Fluency in English. - Expertise in managing multiple complex projects and ability to work independently. - Strong project management skills. - Excellent verbal, written, and presentation skills. - Collaboration, interpersonal, and facilitation skills. - Continuous improvement and organizational effectiveness expertise. - Ability to build collaborative working relationships with colleagues and external associates. - Efficient collaboration across functional and country boundaries, respecting communication and cultural differences. Additional Details: Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.,

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