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Summary:

This position is responsible for managing, developing and maintaining an effective and compliant Supplier Quality System for the Elstree facility in accordance with the Baxter Global Quality System; ensuring compliance with all applicable processes, systems, and provisions of the Quality System, including regulatory requirements such as MDSAP, ISO 13485 and FDA (21 CFR) part 820. MDD & MDR.

This will be achieved through the operational management of key elements of the Quality System including but not limited to the Global Supplier Quality Tracking Systems.

Role and Responsibilities:

This section contains a list of the responsibilities of this role.  The incumbent will perform other duties assigned.

• Manage quality assessments of suppliers to analyze compliance and assess risk activities for the Elstree facility.
• Line manager to Quality System personnel
• Site SME for the change control system and process, working with SME’s to assess and analyze risk prior to change. 
• Site lead for training administration and controlled form system
• Support product label design and approvals for new or existing product changes.
• Support notified body and regulatory authorities inspection.
• Managing the tracking, reporting, adequacy of actions, verification, closeout, and trending of all corrective and preventive actions for supplier audits performed via the Trackwise module.
• Utilise SME’s / auditor(s) to assist the audit / supplier assessment process by collecting and analyzing objective evidence regarding issues and risks. Reporting findings to management team.
• Work with in-house SMEs for the preparation of supplier performance management reports depicting trends and useful data for to present at management review meetings.
• Work with suppliers to improve performance scoring.
• Participate in site projects as a representative of Supplier Quality, as required, including implementation of supplier changes (SNCs).
• Support global activities, including new part / item and supplier approvals.
• Co-ordinate Supplier Corrective Action Requests, ensuring adequacy of actions, verification, closeout, and trending of all corrective and preventive actions.
• Co-Ordinate the site Internal Audit program (Quality and EHS), ensuring audits and corrective actions are completed on time.  Perform own scheduled audits.
• Support the Quality Systems team where required in document publishing, complaints management, change control management and non-conformance management.
• Attend meetings as a representative of Quality, and chair specific meetings as designated by the Head of Quality where Supplier Quality is the focus.
• Involvement and support in plant-wide strategic planning programs and activities where alignment with Supplier Quality is noted.
• Keep updated on Baxter Global Supplier Quality System through attendance of interplant meetings network.
• Keep updated in regulatory trends through attendance at related conferences, seminars, internal meetings, and other training methods such as independent study of periodicals, Internet, or other literature.
• Take on Delegate responsibilities as required by the Head of Quality.
• Participate in continuous improvement initiatives such as EMS, Lean, and 6-Sigma. Identify and lead continuous improvement projects with the objective of achieving quality, reliability and cost improvements for supplier management.

Qualifications, Skills and Experience:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Bachelor’s degree in scientific or technological subject
• A minimum of 2 plus years’ experience required in the areas of GMP regulations that pertain to the medical devices / pharma / biologics - Quality, Manufacturing, Engineering or related field which where possible 1-2 years of supervisory experience is preferable
• Solid understanding of device regulations, including 21CFR Part 11 and 820, ISO 13485 and Medical Device Directives or Regulations
• Previous experience of auditing device/pharma companies/ suppliers is required

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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