Baxter - Supplier Quality Manager

Essential Duties and Responsibilities:

1. Set Quality system requirements to suppliers, including those for services, indirect quality relevant purchases (non-BOM), and QS requirements for suppliers in global markets

2. Perform Qualification of suppliers to medical device, pharmaceutical, combination devices, and/or biologics standards and oversee their placement on the Approved Supplier List (ASL), including ensuring the creation and maintenance of supporting evidence (Supplier Master File)

3. Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics

4. Improve/develop quality systems at selected suppliers for QMS and compliance improvement

5. Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods

6. Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements

7. Assist in preparing for and defending Purchasing Controls in inspections by external agencies or internal Baxter audits of Purchasing Controls processes; Manage and oversee Purchasing controls CAPA, including root cause identification, and effective and timely closure

8. Develop and/or deliver training to internal teams and suppliers.

9. Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed

10. Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions,

11. Coordinate duties and responsibilities of acquisition or divestiture with the facility, develop/execute/complete associated protocol and ensure that all requirements have been completed and facility is live or divested in the GSQ TrackWise database

12. Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.

Qualifications:

- Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, FDA cGMP, MDD, Eudralex, other global or regional equivalent

- Working knowledge of US and International cGMP for API and Excipients

- Experience in Product/process development and/or supplier quality improvement;

- For SQA with technical background, a good knowledge of production/quality development and control methods; CtQ definition, DfSS, SPC, APQP, FMEA, Control Plans, etc.

- Auditing skillsets, up to and including certified SQ lead auditor training; Quality Management System auditing, and where possible, special process auditing skills

- Knowledge of Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business and organization

- Collaboration and Teamwork: Good communications, facilitation, coordination and team skills

- Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions

- Ability to manage the Quality relationship with assigned key suppliers/stakeholders

- Competence in supporting on-site/off-site supplier quality development including coordination/management of resources

- Multi-tasking skills in a demanding fast paced environment

- Superior time-management skills

- Attention to details and a passion for quality

- Superior written and oral communications skill sets

- Willingness to travel (up to 50%)

- Willingness to work as Individual Contributor

Education and/or Experience:

8+ years of experience in Quality, Manufacturing, Engineering or related field.

For SQ Assurance Associates supporting drugs, Pharmaceutical Manufacturing experience is preferred

- Experience performing laboratory methods

- Experience auditing drug manufacturing facilities

- Experience in root cause analysis, corrective and preventive action methods; Expertise/experience in problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA / 5WHY etc.

- Experience with data analysis and reporting using basic Excel toolkit and advanced statistical /process packages such as Minitab or Visio and Powerpoint