Regional Quality Assurance Manager: Africa Operations
7 days ago
This role is responsible for overseeing assigned Contract Manufacturing Organizations (CMOs) portfolio and ensuring all aspects of manufacturing, testing, and release for pharmaceutical products at external supplier sites comply with International and Local standards of current Good Manufacturing Practice (cGMP), current Good Distribution Practice (GDP) regulatory requirements, AQDs, and the applicable Quality Agreements.
Key Responsibilities:- Act as Single Point of Contact (SPOC) for all quality-related activities at assigned external suppliers in the region.
- Provide quality presence, risk assessment, and input to technical meetings with external suppliers and establish good working relationships.
- Co-design and execute Quality Management Systems (QMS) for CMOs management and implement in the related region.
- Responsible for overseeing the quality performance of CMOs with corresponding Key Performance Indicators (KPIs) set.
- Provide front-line support to manage all quality-related issues.
- Responsible for coordination of all GMP and GDP related topics with CMOs, related to operations and/or compliance.
- Communication with CMOs and customers.
- Co-design and execute Sales and Operations Planning (S&OP) meetings with CMOs based on defined frequencies within ESO.
- Oversee, coordinate, and manage product life-cycle changes, product line extensions, or new product launches to ensure orderly and timely transitions of production flow.
- Provide timeous support to the Sales and Supply Chain Teams for batch release.
- Adhere to internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance training.
- Manage and maintain Transport Validation requirements in accordance with GDP for all products.
- Ensure completion of all assigned Company training within the specified timelines.
- Forward all received Product Quality Complaints, Adverse Events, and Medical Information Requests to the relevant person in Quality Assurance/Pharmacovigilance/Medical Affairs.
- Perform any other duties assigned by Senior Management.
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