Divisional Supplier QA Manager

Job Description

Primary Job Function:
u2022 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.
u2022 Provide QA activities for suppliers ensuring compliance to applicable regulatory requirements and Quality Agreements and in co-operation with all relevant functions.
u2022 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.
u2022 To ensure that divisional suppliers maintain compliance to applicable regulatory requirements and Quality Agreements.
u2022 Provide expertise to site supplier QA to drive best practices across Division.

Core Job Responsibilities:
u2022 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.
u2022 To ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases where they are not.
u2022 Support to complete goals with cross-functional/divisional scope ensuring alignment with EPD business strategy.
u2022 Participate on QA cross-functional teams to support suppliers including active participation in Business Management Reviews, as necessary.
u2022 Represent QA in strategic business meetings and communicate with senior management.
u2022 Assure compliance of all divisional products & materials manufactured at suppliers.
u2022 Act as the quality review for significant supplier exception events for impact on product quality, safety, efficacy, and impact to the regulatory filing.
u2022 Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for Suppliers, which identify and address quality, operational, and organizational issues.
u2022 Provide QA expertise to internal and cross-functional teams.
u2022 Provide expert knowledge on all relevant regulations and standards and maintain such knowledge current.
u2022 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.
u2022 Promote continuous improvement, innovation, simplification aligned with Abbott and EPD strategy.
u2022 Embed and drive appropriate risk-based decision making.
u2022 Preparation & maintenance of Audit preparation and Supplier Ownership change form.
u2022 Management of Supplier Performance Monitoring
u2022 Management of Quality Technical agreement with suppliers.
u2022 Management of Supplier change notifications.
u2022 Support in Alternate Supplier Development
u2022 Management of Approved supplier list

Supervisory/Management Responsibilities:
Direct Reports: 0
Indirect Reports: 0

Position Accountability/Scope:
This position is responsible and accountable for:
u2022 Providing QA expertise for divisional suppliers that produce global products for EPD.
u2022 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.
u2022 Decision making as it pertains to quality issues for products manufactures at suppliers impacting EPD business and strategy.

Minimum Education:
u2022 M Pharma in Pharmaceutics
u2022 B- Pharma
u2022 Post Graduate Diploma in Regulatory Affairs.

Minimum Experience/Training Required:
u2022 Total combined years: 8+ in QA, Operations or Pharmaceutical
u2022 Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.
u2022 Knowledge of international and local quality system and compliance legislations and standards, including but not limited to pharma.
u2022 Excellent verbal and written communication skills in Business English.