Quality Assurance Representative

The Global Supplier Quality Management (GSQM) contractor is responsible for executing the Global Supplier Quality Management (GSQM) Program in support of company new site expansions.

The position ensures that 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 to partner, consult and interface 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:

The following activities will be performed according to established procedures, guidelines, forms and tools. These responsibilities are not intended to be all-inclusive nor are they all to be performed by one person:

• 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 company 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 communicate processes to manage the Global Supplier Quality Management (GSQM) process and related initiatives.

• Provide support to ensure maintenance of the supplier 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.

This implies establishment and maintenance of a comprehensive knowledge of all applicable regulations, technical knowledge, and training to meet these responsibilities.

Personal Development

• Be continually aware of current industry trends and regulatory agency interpretation of GMP/cGMP and other relevant requirements, in particular, those related to the Supplier Management Programs.

• Maintain good interpersonal and communication skills with business areas with emphasis on verbal and technical writing skills.

• Complete required training and qualifications for the roles identified in the Learning Plan (LP).

Quals--

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).

• Demonstrated ability to communicate and deliver constructive feedback to customers, including excellent interpersonal and oral presentation skills…. as well as strong written communication skills.

• Creativity in strategy development and problem solving.

• Ability to work independently and as part of a team with minimal supervision.

• Ability to communicate, convince, train.

Additional Skills/Preferences includes:

• Five (5) years of minimum experience at 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 company manufacturing sites.

• Proficient English oral and written skills and experience