Divisional Supplier QA Manager Full Time

• Supports implementation of strategy at suppliers, ensuring compliance is maintained and business needs supported. Any areas of risk to product quality, patient safety, or market supply are managed directly by this position, including establishment and execution of appropriate actions and communication to senior leadership.
• Provide QA activities for suppliers ensuring compliance to applicable regulatory requirements and Quality Agreements and in co-operation with all relevant functions.
• Lead the quality related activities at Suppliers producing divisional products on behalf of Abbott, to ensure safe, efficacious, and quality product can be supplied in accordance with regulatory and business requirements.
• To ensure that divisional suppliers maintain compliance to applicable regulatory requirements and Quality Agreements.
• Provide expertise to site supplier QA to drive best practices across Division.

Core Job Responsibilities :

• Develop and consistently execute a quality strategy for divisional suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.
• To ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases where they are not.
• Support to complete goals with cross-functional/divisional scope ensuring alignment with EPD business strategy.
• Participate on QA cross-functional teams to support suppliers including active participation in Business Management Reviews, as necessary.
• Represent QA in strategic business meetings and communicate with senior management.
• Assure compliance of all divisional products & materials manufactured at suppliers.
• Act as the quality review for significant supplier exception events for impact on product quality, safety, efficacy, and impact to the regulatory filing.
• Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for Suppliers, which identify and address quality, operational, and organizational issues.
• Provide QA expertise to internal and cross-functional teams.
• Provide expert knowledge on all relevant regulations and standards and maintain such knowledge current.
• Act as QA SME in cross-functional and cross-divisional project teams, working with other functions including pharmacovigilance, regulatory, commercial, divisional product protection to integrate Quality strategy.
• Promote continuous improvement, innovation, simplification aligned with Abbott and EPD strategy.
• Embed and drive appropriate risk-based decision making.
• Preparation & maintenance of Audit preparation and Supplier Ownership change form.
• Management of Supplier Performance Monitoring
• Management of Quality Technical agreement with suppliers.
• Management of Supplier change notifications.
• Support in Alternate Supplier Development
• Management of Approved supplier list

Supervisory/Management Responsibilities :

Direct Reports : 0

Indirect Reports : 0

Position Accountability/Scope :

This position is responsible and accountable for :

• Providing QA expertise for divisional suppliers that produce global products for EPD.
• Ensuring that divisional suppliers maintain compliance with the Quality Agreements and local and international regulations as required by markets supplied and ensuring that the quality systems are appropriate so that the product safety, efficacy, and quality are maintained.
• Decision making as it pertains to quality issues for products manufactures at suppliers impacting EPD business and strategy.

Minimum Education :

• M Pharma in Pharmaceutics
• B- Pharma
• Post Graduate Diploma in Regulatory Affairs.

Minimum Experience/Training Required :

• Total combined years : 8+ in QA, Operations or Pharmaceutical
• Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.
• Knowledge of international and local quality system and compliance legislations and standards, including but not limited to pharma.
• Excellent verbal and written communication skills in Business English.