Job description

Job Description:

Responsibilities:

Execute the 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 the 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).

Education:

Associate’s Degree or other advanced education or training.

Experience:

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:

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