at Baxter Healthcare Corporation in Round Lake, Illinois, United States
Job Description
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
Your Role at Baxter:
Independently manages Supplier Quality Assurance activities for assigned suppliers focused on an assigned commodity (including resins, plastics, and molding; or Active Pharmaceutical Ingredients (APIs), excipients, and chemicals; or packaging, glass, needles, devices). Responsible for activities such as execution of quality assessments/audits, negotiation and implementation of Quality Agreements, monitor and reporting of metrics. Manage Quality and Compliance related issues between suppliers and Vantive.
What you'll do:
Set Quality system requirements to suppliers within the employee's defined commodity portfolio,
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)
Conduct and oversee supplier audits-qualification and re-qualification, including finding closure; Collect, trend and report supplier quality metrics
Oversee and negotiate Quality Agreements between suppliers and Baxter.
Improve/develop quality systems at selected suppliers for QMS and compliance improvement
Develop purchasing controls processes, procedures and systems, including those for BOM, non-BOM, services, spare parts and Third Party Finished Goods
Evaluate and improve the effectiveness of purchasing controls and supplier quality processes and procedures, including Quality Agreements
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
Develop and/or deliver training to internal teams and suppliers.
Execute SCAR management, effective and timely closure and Review/risk assessment of Supplier Quality Notifications and their escalation to SCARs and NCR where needed
Accountable for NCR as assigned, conducting NCR timeliness and effectiveness reviews, and trending for corrective/preventive actions,
Support Manufacturing, Regulatory, Quality and Purchasing organization for third party suppliers related activities, as applicable.
What you'll bring:
Higher level of technical education (e.g., Science degree, Diploma, or Alternative technical Bachelor's degree or non-technical degree, diploma or Certificate)
5+ years of experience in Quality, Manufacturing, Engineering or related field; cross-industry experience a plus (e.g., automotive, aerospace, combination products, pharmaceuticals)
Manufacturing experience is preferred in resins, plastics, and molding; or API, excipients and chemicals; or packaging, glass, needles, and medical devices. Experience with other commodities relevant to medical devices or pharmaceuticals will also be considered
Experience performing laboratory methods
Experience auditing manufacturing facilities relevant to the defined supplier commodity portfolio
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
Knowledge of pharmaceutical and/or medical device regulations, e.g., ISO 13485, ISO 9001, FDA cGMP, MDD, Eudralex, other global or regional equivalent
Working knowledge of US and International cGMP as it applies to the... For full info follow application link.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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