Job Description
Primary Job Function:
- Ensure quality oversight of divisional suppliers in line with Abbott and EPD quality standards, local regulatory requirements, and Quality Agreements.
- 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.
- Support the implementation of Quality strategy with divisional suppliers, ensuring compliance with regulatory requirements and business objectives.
- Act as QA contact for divisional suppliers, ensuring timely communication with the Supplier QA leadership.
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.
- Prepare and maintain supplier quality metrics / reports for divisional suppliers.
- Collaborate with cross-functional teams (regulatory, supply chain, manufacturing, commercial) to resolve supplier-related quality matters.
- Support in Alternate Supplier Development.
- Ensure Approved supplier list is maintained up to date.
- Escalate risks and critical quality issues to the Supplier QA Manager, providing input and recommendations.
- Support continuous improvement of supplier quality processes at the divisional level.
- Preparation & maintenance of Audit preparation and Supplier Ownership change form.
- Prepare and maintain supplier quality metrics and reports for divisional suppliers.
- Management of Supplier Performance Monitoring
- Management of Quality Technical agreement with suppliers.
- Management of Supplier change notifications.
- Support in Alternate Supplier Development
Supervisory/Management Responsibilities:
Direct Reports: 0
Indirect Reports: 0
Position Accountability/Scope:
This position is responsible and accountable for:
- QA oversight of divisional suppliers within 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:
- Bachelor's degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries.
Minimum Experience/Training Required:
- Minimum Five years experience in Quality Assurance or related functions within the pharmaceutical industry.
- Practical knowledge of supplier quality management, GMP/GDP requirements, and regulatory compliance.
- Excellent verbal and written communication skills in Business English.
