Supplier Quality Assurance

19 hours ago

Indianapolis, Indiana, United States Integrated Resources, Inc ( IRI ) Full time

Title: Supplier Quality Management

Location: Indianapolis, IN

Duration: 12+ months

Job Description:

  • The Global Supplier Quality Management (GSQM) contractor is responsible for executing the Global Supplier Quality Management (GSQM) Program in support of Client new site expansions.
  • The position ensures that the Supply Chain & Affiliates organization provides central execution support in onboarding suppliers, materials, and GMP service providers in a timely manner to support project timelines with new site expansions.
  • The contractor is responsible for partnering, consulting and interfaces with business partners to implement across networks and functions to meet business needs.
  • The GSQM process focus is to provide a globally holistic process in which GMP supplier and GMP service provider's Supplier Quality Management activities are globally consistent, available, and executed by a central function to maintain patient safety, product quality, and technical elements at the highest standard and compliance.

Key Objectives/Deliverables:

  • Execute supplier quality management process in compliance with Global Quality Standards (GQS305, GQS301 & GQS307) in addition to others, as applicable.
  • Assist procurement, supply chain, GQAAC, MMQA, TS/MS, and manufacturing functions in identifying and managing material suppliers and GMP Service Providers.
  • Execute SAP and TW138 activities in the approved supplier list (ASL) process of suppliers and/or GMP service providers for Client site expansions on behalf of the sites. Collaborate with SAP Business QA as needed.
  • Collaborate and communicate with manufacturing/affiliate sites across the networks (API / Manufacturing / Packaging / DPEM / APIEM / Devices) to ensure process execution is robust and effective, and barriers are escalated.
  • Develop and communication processes to manage the Global Supplier Quality Management (GSQM) process and related initiatives.
  • Provide support to ensure maintenance of the supplier's quality management data, including approved supplier and GMP service provider list, in the appropriate systems, e.g., SAP, VeevaVault (QDocs), TrackWise.
  • Support execution of Certification Package Review Board and global certification packages for global SAP Manufacturing Plants (MPs) materials.
  • Partner with Global TS/MS to develop and execute the material risk control strategy (material risk, product acceptance risk, specification controls).
  • Provide input and support for supplier-related change controls.

Qualification:

  • Associate's degree or other advanced education or training.
  • Excellent knowledge in manufacturing operations, quality, and supplier quality management is preferred.
  • Experienced in SAP, TrackWise, and Veeva QualityDocs is preferred.
  • Experienced in Change Management.
  • High ability in execution of MS Office basic suite (Teams, OneNote, OneDrive, Sharepoint, PowerPoint, Excel).

Additional Skills/Preferences includes:

  • Five (5) years of minimum experience at a manufacturing site within QA organization.
  • Good knowledge of quality management; Supplier Quality Management; ISO and GMPs.
  • PowerApps, PowerBI, Tableau experience.
  • Knowledge of GQS, CQP, LQP

Additional Information includes:

  • May require visits to Client manufacturing sites.
  • Proficient English oral and written skills and experience.

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